Total 31 Manager Corporate Affairs Executive job vacancies in Quality Assurance / Control category in The United States of America

Job Responsibilities:

1. New product registration:

• Prepare and compile registration dossiers in accordance with relevant regulatory requirements including: 
  

  • Constructing/ editing letters of response/ justification/ declaration and clinical documentation for submission packages in accordance with guidelines checklists.

  • Compile/ review/check material for dossier prior to submission, incorporate feedback from relevant stakeholders.

  • Conduct checks on artworks to ensure in compliance with local regulation.

• Submit product registration applications to local health authorities  according to target submission timelines.
• Liase with and respond to additional requests or queries from health authorities and follow up (when necessary) until approval per target timelines.
• Liase with enternal and external stakeholders/ departments to build rapport and to achieve target outcomes.

2. Comply with regulatory requirements: to maintain validity of existing licenses/ certification/ authorization (e.g, product licenses, manufacturing licenses, establishment license, GDPMD licenses, import/ export license) through timely variations and/ or renewals to ensure supply continuity.

3. Keep abreast of regulatory updates from health authorities in the drugs, cosmetics, and medical device space.

• Assess regulatory updates on impact to business and communicate insights on approach to handle affairs.
• Propose solutions to arising issues.

4. Update and maintain database of regulatory and product registration information.

5. Good maintenance of final submitted documentation and local repository.

6. Ensure compliance with quality procedures stipulated for regulatory affairs, its administartive maintenance, and plan/ suggest improvements to operations.

7. Support any audits or inspections.

8. Guide/ oversee work performance and development of direct report.

9. Provide input for periodic operation metrics/ budget initiatives by managing  operating expenses within approved budget for the year.

10. Handle any other assingment as advised by supervisor.

Requirements: 

• Possess a Bachelor Science
• Work experience in regulatory affairs.
• Familiar with drugs/ cosmetics/ medical device regulatory landscape and GxP related matters.
• Proficiency in Microsoft Office Applications and relevant regulatory system software.
• Adopt good practices in documentation and communication.

Perks & Benefits

• Allowance ( mileage,transportation)
• Medical insurance

工作職責：

1、新產品註冊：

• 根據相關監管要求準備和編制註冊檔案，包括：
  

  • 根據指南清單建立/編輯提交包的回應/理由/聲明和臨床文件。

  • 在提交之前編譯/審查/檢查檔案資料，納入相關利害關係人的回饋。

  • 對藝術品進行檢查，以確保符合當地法規。

• 根據目標提交時間表向當地衛生部門提交產品註冊申請。
• 與衛生當局聯絡並回應其他請求或詢問，並跟進（必要時）直至按照目標時間表獲得批准。
• 與內部和外部利害關係人/部門聯絡，建立融洽關係並實現目標成果。

2. 遵守監管要求：透過及時變更和/或更新來維持現有許可證/認證/授權（例如產品許可證、製造許可證、企業許可證、GDPMD許可證、進出口許可證）的有效性，以確保供應連續性。

3. 隨時了解衛生當局在藥品、化妝品和醫療器材領域的最新監管動態。

• 評估監管更新對業務的影響，並就處理事務的方法傳達見解。
• 針對出現的問題提出解決方案。

4.更新和維護監管和產品註冊資訊資料庫。

5. 妥善維護最終提交的文件和本機儲存庫。

6. 確保遵守監管事務、行政維護規定的品質程序，並規劃/建議營運改善。

7. 支持任何審計或檢查。

8. 指導/監督工作績效和直接報告的發展。

9. 透過在年度核准的預算內管理營運費用，為定期營運指標/預算計畫提供輸入。

10. 處理主管建議的任何其他分配。

要求：

• 擁有科學學士學位
• 監管事務方面的工作經驗。
• 熟悉藥品/化妝品/醫療器材監管環境和 GxP 相關事宜。
• 熟練Microsoft Office應用程式和相關監管系統軟體。
• 在文件和溝通方面採用良好的做法。

津貼和福利

• 津貼（里程、交通）
• 醫療保險

About Us

The Singapore Human Resources Institute Pte Ltd is an HR Training institution that caters to the knowledge and skill development needs of both local and international adult learners. With a comprehensive training and education curriculum, SHRI Academy offers lifelong learning opportunities and a diverse range of academic programs, from basic certificates to master degree levels under its SHRI School of Human Capital Management. SHRI ACdemy is a 4-year EduTrust-certified institute (12/10/2021 to 11/10/2025)

Primary Responsibilities:

• Develop and Enforce policies and procedures and initiates corrective actions.
• Contributes information and analysis to strategic plans and reviews; prepares and completes action plans; implements programs to improve overall productivity, quality, and customer-service standards
• Design and Completes internal audits; determines system improvements; implements change.
• Prepares quality documentation and reports by collating, analysing and summarising information and trends including processes and recommending necessary changes to the Director (L&D)
• Main Liaison Person with the relevant authorities (such as CPE & SSG).
• In the capacity as MR under SSG, to submit Course Proposal for the application of funding and course accreditation until approval stage.
• Responsible for the proper archiving and documentation of all ERF and EduTrust-related documents.
• Preparing for audits and assessments conducted by regulatory bodies, including ERF audits and EduTrust certification.

Secondary Responsibilities:

• Prepare timely reports for management information, including sales budget for the Academy Team.
• Participate in relevant corporate activities and initiates spearheaded by the Management.

Key Responsibilities:

Quality Assurance Management:

• Develop and implement a comprehensive quality assurance program for airline back office and corporate travel management services
• Establish communicate and monitor quality standards performance metrics and key performance indicators KPIs
• Conduct regular quality audits and evaluations of processes transactions and customer interactions

Team Leadership

• Lead mentor and motivate a team of quality assurance professionals
• Provide coaching and training to ensure consistent and high-quality performance
• Foster a culture of accountability continuous improvement and teamwork within the quality team

Continuous Improvement

• Identify areas of improvement and work with cross-functional teams to implement enhancements
• Proactively address service gaps and implement corrective actions to prevent future issues
• Stay up to date with industry best practices and emerging trends to enhance our services Quality

Reporting

• Create and distribute regular quality reports to management highlighting performance trends areas for improvement and success stories
• Analyze data to identify root causes of quality issues and recommend solutions

Client and Stakeholder Communication

• Collaborate with clients to understand their quality expectations and feedback
• Act as a liaison between clients and internal teams to address quality concerns and implement improvements

Compliance and Standards

• Ensure compliance with industry regulations and quality standards
• Keep abreast of changes in regulations and standards to maintain compliance

Ensuring all Quality Management Systems GxP, relevant  to  ISO 9001 ;2015  and GLP & GMP guidelines and applicable statutory regulatory and client requirements.

o   Conducting Internal Audits as per Internal Audit Program.

o   Conducting external audit as per External Audit program.

o   SOP  Management .

o   Training Management .

o   Change Management, Deviation Management and CAPA in compliance with GxP, Regulatory and Client requirements.

o   Handling the Regulatory/ISO/client audits and tracking for the efficient closure of CAPA.

o   Participating actively in investigations related to critical non compliances.

o   Conducting “FOR CAUSE” audits to investigate Quality issues.

o   Coordination with BSI auditor to get ISO & GLP , GMP certifications , NABL Certifications and any additional as per Management requirements .

o   Risk  Assessments ,  Qualification of Instruments and Equipments . CSV validation .

o   Knowledge of archival management.

Any additional responsibility that business demands

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus

Responsibilities:

· Prepare and review compliance handbook

· Handle MAS filings and inquiries from regulatory bodies

· Perform regular compliance checking to ensure compliance with regulatory requirements

· Handle KYC and AML-related matters as well as client onboarding compliance check

· Provide relevant advisory to business/support units and other AML teams on matters relating to compliance issues, transaction monitoring review and investigation conducted by the unit

· Perform analysis of suspicious transaction/activity reports to identify AML risk trends to support the AML risk management and controls within the Group

· FATCA / CRS reporting in accordance with relevant requirements

· Handle CPT related matters, such as update of CPT register

· Develop regulatory governance frameworks, policies, and procedures to effective management of regulatory risks for company, clients

· Facilitate and address any MAS queries and external authorities, as well as internal and external audits

· Familiar with outsourcing guidelines and prepare relevant policies, procedures and documents in compliance with MAS regulations and guidelines

· Undertake other ad-hoc duties as assigned

Requirements:

· University Degree in Business, Law, Finance or related disciplines

· At least 3 years of strong compliance experience in local regulatory compliance and risk management, with demonstrable knowledge of relevant regulatory requirements

· Strong knowledge or prior experience in key regulatory requirements such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, and AML/CFT regulations

· Work independently, self-motivated, strong analytical skills and ability to exercise sound judgment and manage execution under pressure

· Familiar with FATCA and CRS reporting is preferred

· Effective communicator in both English and Mandarin to liaise with Mandarin speaking clients

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus

1. Support the implementation of quality measures for nursing homes, which includes:Planning and organizing engagements with nursing homes to share the purpose and details of the quality measures.

• Presenting (using Tableau) and analysing the data for the quality measures.
• Preparing reports for CCOs and AIC management.
• Addressing questions from CCOs with regards to the quality measures.

2. Support the development of quality measures for other eldercare services, which includes:

• Reviewing local service/regulatory requirements, good practices, international practices to identify potential quality measures for home nursing care and other community-based care services.
• Conducting a preliminary analysis and presenting the findings.
• Liaising with other AIC Divisions to support the team’s quality measurement work.
• Organising meetings with the appointed workgroup, who will deliberate and select the quality measures for the sector.

3. Assist in the implementation of other key quality initiatives such as:

• Facilitating discussions with nursing homes to develop action plans with the aim of improving the safety culture in their organisations.
• Supporting the implementation of a quality assurance programme involving nursing homes and home nursing care providers.

Job Requirements:

• Degree in any discipline with 1 to 3 years of working experience. Entry-level candidates will also be considered
• Experience in data collection, analysis, visualisation and reporting; and knowledge of the community care sector would be an advantage
• Familiarity with analytics and statistical software e.g., Tableau, Stata would be an advantage
• Effective interpersonal, engagement and follow-up skills
• Strong written and verbal communication skills
• Passion for quality and ageing issues
• Resilient and results-oriented

Responsibilities:

· Prepare and review compliance handbook

· Handle MAS filings and inquiries from regulatory bodies

· Perform regular compliance checking to ensure compliance with regulatory requirements

· Handle KYC and AML-related matters as well as client onboarding compliance check

· Provide relevant advisory to business/support units and other AML teams on matters relating to compliance issues, transaction monitoring review and investigation conducted by the unit

· Perform analysis of suspicious transaction/activity reports to identify AML risk trends to support the AML risk management and controls within the Group

· FATCA / CRS reporting in accordance with relevant requirements

· Handle CPT related matters, such as update of CPT register

· Develop regulatory governance frameworks, policies, and procedures to effective management of regulatory risks for company, clients

· Facilitate and address any MAS queries and external authorities, as well as internal and external audits

· Familiar with outsourcing guidelines and prepare relevant policies, procedures and documents in compliance with MAS regulations and guidelines

· Undertake other ad-hoc duties as assigned

Requirements:

· University Degree in Business, Law, Finance or related disciplines

· At least 3 years of strong compliance experience in local regulatory compliance and risk management, with demonstrable knowledge of relevant regulatory requirements

· Strong knowledge or prior experience in key regulatory requirements such as the Securities & Futures Act, Financial Advisers Act, MAS Notices and Guidelines, and AML/CFT regulations

· Work independently, self-motivated, strong analytical skills and ability to exercise sound judgment and manage execution under pressure

· Familiar with FATCA and CRS reporting is preferred

· Effective communicator in both English and Mandarin to liaise with Mandarin speaking clients

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus

The Role

My Client is a global Infrastructure and Corporate Firm and they are looking for a Group Compliance Manager to join the team in Singapore. They are a leading Conglomerate with multiple businesses and we are looking for candidates who are keen to grow their career in a leading brand name within the industry.

Responsibilities

• To implement and roll out Compliance, Internal Controls, and Anti Bribery Framework
• Develop and ensure that internal Compliance and Controls policies are robust
• End to end Compliance duties such as Anti Bribery, Code of Conduct, FCPA etc
• Spearhead new Compliance programs such as Sanctions and provide advisory to the business leaders
• To support any new systems and training related to Compliance
• Ensure that the Compliance polices are in line with local laws and regulations
• Implement new Data Privacy policies and procedures
• Any other adhoc Compliance related projects and processes.

Requirements

• Minimally 7 years of Compliance experience in a Corporate setting
• Strong understand of functions across Audit, Risk, and Internal Controls
• Ability to work independently and remotely with global stakeholders.
• Strong interpersonal skills with the ability to influence senior leaders

Take charge of this opportunity to welcome a new career challenge in 2024.

EA Personnel No R1985201

BeathChapman Pte Ltd

Licence No 16S8112

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus

Duties and Responsibilities :

• Assist Senior Manager of Quality & Compliance to oversee the ISO Quality Management System held by the company.

• Work with internal stakeholders from Air Freight, Ocean Freight, Logistics, Courier, Cross Border Trucking Departments in achieving and meeting the set quality standards and procedures.

• Conduct training to stakeholders on topics related to quality standards and procedures.

• Work with internal stakeholders to understand and to meet the needs of customers.

• Gather quality objectives achievement metrics by internal stakeholders.

• Gather quality objectives achievement metrics by key suppliers.

• Work with internal stakeholders to gather customer satisfaction metrics.

• Monitor compliance to national and international quality standards and related regulations.

• Participate in quality related activities such as audit, qualification program, claims etc

Requirement

Minimum 2 years’ experience in quality management QC related field

Diploma level or higher. Knowledge of ISO9001, ISO13485 or SS620, TAPA or TradeFIRST.

Computer literate.

Details oriented with Excellent communication skills

Able to meet deadlines

Experience in managing a team

Prior working experience in freight forwarding/Logistics industry is a plus