Executive Director, Quality Assurance

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Executive Director, West Point Quality Assurance, reports to the Associate Vice President, West Point Site Quality Head, and supports all Quality Assurance and GMP compliance activities relating to the manufacture of vaccine products including medical device combination products (MDCP) at the West Point site to ensure compliance with all applicable marketed health authority regulations and specifications. The Site Quality Assurance lead is a member of the site Quality leadership team and is responsible for implementing Divisional, Company and Site policy, procedures and guidelines across the site. This role directly leads activities in the execution, oversight and improvement of Quality System functions relating to vaccine and MDCP GMP compliance including:

1. Coordinates and directs teams of multi-disciplined professionals in areas of process and systems, as they relate to Quality System enhancements.

2. Oversees the execution of key Quality Systems, including:

a. Change control

b. Deviation Management

c. Documentation, including SOP administration and issuance of controlled forms and batch records

d. Annual Product Reviews

e. Data Governance

f. Agency reporting of BPDRs, FARs, MDRs and market actions

g. Internal auditing

h. Laboratory Quality Assurance

i.. CAPA and Commitment management

j. Complaint and Adverse Event Management

k. Supplier Management including Quality Agreements

l. Quality Council and Quality Management System

3. Maintains compliance proficiency and utilizes this information to identify and evaluate emerging trends, evolving regulations for incorporation to Quality Systems requirements including:

a. Leadership in health authority regulatory inspections

b. Review of inspection reports from other sites/health authorities

c. Attending and participating in local quality forums

d. Participation in industry working groups

e. Surveillance of health authority regulatory publications and guidance

4. Acts as the primary liaison for health authority regulatory inspections, in collaboration with the Site Quality Head.

5. Performs trending within Quality Systems to identify actions for improvement. Sponsors multi-department, site-based teams regarding compliance initiatives, problem solving, continuous improvements and assessments.

6. Responsible for hiring and ensuring Quality Assurance personnel are trained, and administers all personnel policies and development programs. Ensures personnel operate within established policies/procedures of Merck and in compliance with cGMPs and all applicable governing regulations.

7. Responsible for managing the Quality Line Oversight rotational program, which includes Acceptable Quality Limit sampling across the site.

8. Responsible for managing the Laboratory Quality Assurance team, which includes Quality Assurance oversight for all laboratory activities including approval of testing results and laboratory deviations, protocols and change controls.

Education:

• Bachelor's Degree with at least 15 years of industry experience

• Masters or PhD preferred

Required:

• 10 + years of work experience in a medical device, pharmaceutical, biologic and/or vaccine manufacturing environment or a strongly related, similarly regulated field.

• Concurrently, five (5) years of managerial experience, with responsibility for direct and indirect reports.

• Strong understanding of cGMPs, FDA and EMEA regulatory standards. Strong compliance mindset.

• Excellent writing skills.

• Strong lean mindset with MPS/Kata capabilities.

• Ability to be self-motivated and work independently, yet collaboratively in team settings and within matrix organizations to achieve objectives.

• Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position.

Preferred:

• Previous work within Sterile/Vaccines manufacturing companies or regulatory authorities.

• Experience in compliance remediation activities at plant sites.

• Experience and/or exposure in Plant audits and Supplier Audits

• Experience in Regulatory Commitments implementation and effectiveness

• Minimum of two (2) different management pathway roles or experiences

• Accountable for actions, drives results, and learns from mistakes.

• Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions.

• Communicates influences and escalates issues and decisions, as appropriate.

• Goes to the shop floor to see the problems and work directly with people on the shop floor.

• Demonstrates tolerance for ambiguity.

• Experience in CAPAs effectiveness and Implementation

• Previous exposure to documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls.

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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R230162