Job Description
As a member of the Medical Device Combination Products Quality QMS group, the Associate Director, will participate in and/or lead various initiatives in support of our Manufacturing and Research Division's QMS Purchasing Control objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data.
The Associate Director will collaborate and interact with cross-functional and cross-divisional teams to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives related to Purchasing Controls.
Key Functions:
- Developing, documenting and maintenance of supplier quality agreements, audits of suppliers, supplier information, procedures, and systems to ensure compliance with MDCP current Good Manufacturing Practices (cGMPs), other Global Health Authority Regulations and our company's requirements.
- Accountable for other Quality Programs, as assigned.
- Understands the evolving global health authority regulatory requirements and works proactively to assure our company's is in a state of compliance.
- Works on all purchasing control phases for MDCP suppliers: planning, supplier evaluations/audits, supplier selection/acceptance, quality agreements, maintenance, and sustainability.
- Supports Supplier Audits, as Medical Device and Combination Product SME.
- Integrate Purchasing Control Activities into Integrated Project Plan for each MDCP Program (with target dates) for execution.
- Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation action plans (incoming inspection and final assembly processes) for MDCP suppliers.
- Support the development of our company's supplier specification based on intended use and our company's user needs which includes defining list of requirements needed to be specified to supplier (quality, technical, commercial, supply) - shelf life, critical attributes, essential performance requirements, etc.
- Participates on our company teams supporting MDCP cGMP and quality issues related to pure Medical Devices and the device constituent part of a Combination Product.
- Manage activities within electronic computer systems, e.g., Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems, etc.
- Supports the development and implementation of MDCP Quality Agreements, Supplier Agreement, Global Procedures, as needed.
- Provides training and coaching to initiate quality improvements with Supplier Quality Management, Procurement, Supply Chain and Sites, as needed.
- Support MDCP sites with new/revised Quality Agreements and/or Global Procedures.
- Perform related duties, as assigned.
Minimum Education and Experience Requirement:
- Bachelor of Science (BS) degree in a science or engineering discipline with a minimum of eight (8) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products. OR
- Master of Science (MS) degree in a science or engineering discipline with a minimum of six (6) years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products.
Required Experience and Skills:
- Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents.
- Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products.
- Must be able to build relationships within a team environment.
- Experience using computer systems for Quality Management Systems.
- Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.
- Experience authoring, reviewing and approving Quality Management System documents.
- Solid organizational skills including attention to detail and multi-tasking skills.
- Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others.
- Effective written and oral communicator, ability to speak up and contribute to a team forum.
Preferred Experience and Skills:
- Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for our company's Quality Manual.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
