Total 2 Director/C-Level Business Development job vacancies in Quality Assurance / Control category in The United States of America

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

WORKING AT ABBOTT:

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

THE OPPORTUNITY:

The Director of Technical Quality Support is responsible for directing a team of quality engineers focused on validation and design control of products and processes, including software and technical quality assurance personnel. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight for FDA communications regarding compliance issues. Provide strategic consulting for the division by interfacing directly with the divisions on policy development and deployment. Develop and assess key metrics. Provide senior management with impact of regulatory changes.

This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements.

Work effectively with multiple different divisions and medical device technologies.

Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.

Responsible for:

Quality assurance activities for software and firmware development for health care products, including both medical and non-medical applications

Quality assurance activities for hardware development for health care products.

Creating and maintaining an efficient, highly motivated, quality engineering organization.

WHAT YOU’LL WORK ON:

• Provide overall direction and leadership for validation, design and qualification to assure product quality for application software, embedded firmware and hardware products for medical monitoring systems.
• Develop, implement and improve quality policies, processes and procedures, automated systems and reporting systems.
• Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department.
• The incumbent must understand the details of the areas involved. Possess strong leadership skills, an overall knowledge of healthcare industry regulations, ability to effectively negotiate and strong communication skills.
• Provide strategic consulting for programs being developed or implemented.
• Facilitate policy development and deployment throughout the corporation.
• Work to achieve program standardization between businesses.
• Develop and assess metrics for each center.
• Lead and facilitate implementation of new regulations.
• Train our various businesses on new requirements for compliance.
• Standardize approach to implementation of new regulations.
• Provide oversight of quality and compliance goals.
• Interface directly with the divisions on policy development and deployment
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
• Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process, including on-market risk evaluation and assessments. Making decisions on whether or not to take action on market to remedy non-conforming product on-market.
• Utilizes practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) experience with Agile/Lean software development lifecycle process
• Complies with worldwide regulations, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assure line of communication with DVP QA and Senior Leaders on critical quality issues that may result in potential business interruption.
• Assure business continuity in leadership positions and critical roles through talent management planning and development.

QUALIFICATIONS:

• Bachelor's Degree in Engineering, Computer Science or technical discipline or equivalent experience in software field.
• Master’s degree in a technical discipline ideal.
• Minimum 10 years in Progressive work experience in software related medical device or high technology industries. Minimum 10 years prior management experience.
• Requires technical background and direct experience of product development activities for software and/or hardware for leading edge medical devices.
• Demonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the products.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel, including internationally >50% of time.

APPLY NOW:

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

     

The base pay for this position is

$155,300.00 – $310,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

AQR Abbott Quality and Regulatory

        

LOCATION:

United States > Abbott Park : AP52

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 50 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Career Category

Compliance

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Director Compliance – Business Development and Program Effectiveness

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will support Business Development initiatives and build and execute a strategy to measure the effectiveness of our Ethics & Compliance program. The Director will report to the Vice President of Worldwide Compliance and Business Ethics (WC&BE) and will serve as a key member of this Vice President’s leadership team. You will evaluate Amgen’s business development opportunities from an ethics and compliance perspective, including merger and acquisitions, joint ventures, strategic equity investments, licensing opportunities, research and clinical development collaborations, and other transactions that advance the execution of Amgen’s growth strategy. You will also directly identify opportunities for transformation of Amgen’s Compliance-related metrics and key performance indicators. This will involve continually assessing WC&BE programs, the external environment, and relevant data to develop and execute on a strategy for assessing and evaluating each element of Amgen’s Ethics and Compliance program.

As a Compliance Director, you will:

• For business development opportunities, (1) conduct and evaluate the results of compliance-related due diligence, (2) assess and propose mitigation strategies for associated risks, (3) review and help negotiate compliance-related agreement provisions, (4) lead post-deal integration and implementation for WC&BE, and (5) understand and communicate impact of transactions on internal stakeholders

• Maintain and continually enhance WC&BE business development playbook

• Proactively and continually assess opportunities for measuring program effectiveness across the areas of policies and procedures, training, communications and Code of Conduct; business ethics; reporting, investigations and monitoring; processes, capabilities, technology and automation; and program execution

• Bring a succinct point of view and business perspective, backed by data, to the WC&BE leadership team and other relevant leadership teams along with strong decision-making skills and the ability to understand and successfully implement WC&BE strategies

• Consistently monitor external industry trends and regulatory environment, and integrate inputs across WC&BE, to create practical strategies to measure effectiveness and drive continuous improvement

• Assess performance, identify, retain and develop key talent for the organization while crafting the future of the organization so as to develop the best team

• Deploy strong leadership and communication skills and the ability to influence vertically, diagonally and horizontally

Domestic travel up to 20% for business-related activities may be required

Location: While hybrid from accessible commute to Amgen Thousand Oaks, CA is preferred this role may also be in a remote capacity with some expected travel.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The compliance professional we seek is an innovative leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Compliance, Legal, Audit, Monitoring, Regulatory or similar experience

Or

Master’s degree and 7 years of Compliance, Legal, Audit, Monitoring, Regulatory or similar experience

Or

Bachelor’s degree and 9 years of Compliance, Legal, Audit, Monitoring, Regulatory or similar experience

Preferred Qualifications:

• Pharmaceutical/Biotech industry experience, particularly in Compliance, Legal, Audit, Monitoring, Regulatory Affairs, and/or cross-functional experience in Sales, Marketing, or Medical

• Strong communication skills and the ability to influence those around him/her

• Strong collaborator and self-starter

• Strong executive presence

• Critical thinker and strategic, creative and proactive problem solver who effectively drives issues to closure

• Agile and able to adjust to ambiguity, complexity and changing directions quickly to meet urgent business needs

• Working knowledge and understanding of Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers, Pharmaceutical Research and Manufacturers of America (PhRMA) Code, U.S. Federal Anti-Kickback Statute (AKS), False Claims Act (FCA), current Corporate Integrity Agreements (CIAs), Accreditation Council for Continuing Medical Education (ACCME) guidelines, Prescription Drug Marketing Act (PDMA), FDA commercial guidelines, U.S. Federal and State data privacy laws and regulations, U.S. Federal and State transparency reporting requirements, similar laws and regulations in countries outside the U.S., and other relevant laws and regulations

• Understanding of sales, marketing, value & access, product promotion, disease education, device regulatory, clinical research, and healthcare compliance

• Strong ability to synthesize and analyze vast amounts of complex data, and clearly and concisely articulate relevant points and conclusions at the right altitude depending on the purpose and the audience

• Ability to initiate, handle, prioritize, and follow through on a high volume of work

• 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear.

Join us. careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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Salary Range

175,069.00 USD - 200,609.00 USD