Associate Director, Quality Systems

2 weeks ago

West Point, United States Merck Sharp & Dohme Full time

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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**Position Responsibilities**:

- The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers.
- Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits.
- Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes.
- Maintain an understanding our company policies, procedures, and guidelines.
- Maintain awareness of evolving industry and regulatory trends/regulations.
- Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits
- Coordinate with Site Quality leads on audit refusals and postponements.
- Lead project initiatives, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet site, management, and regulatory expectations

**Education Minimum Requirement and Experience**:

- Bachelor’s degree in science (BS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with ten (10) years’ experience performing audits and/or quality operations experience. **OR**:

- Master’s degree in science (MS) in Chemistry, (Micro-) Biology, Engineering (or equivalent) with eight (8) years' experience performing audits and/or quality operations experience.

**Required Experience and Skills**:

- Thorough understanding of Quality Management Systems and process to support the manufacturing of drug substances, drugs products, and medical devices.
- Ability to work independently with limited supervision in a virtual-management environment.
- Excellent communication, negotiation, influencing, and strategic thinking skills.
- Review and approve audit reports (as assigned).
- Must be detail oriented and organized.
- Must be a positive change agent and able to adapt in a dynamic environment.
- Must have the ability to travel globally approximately 50% of the time.

**Preferred Experience and Skills**:

- Extensive experience auditing biologics and vaccine manufacturing sites.
- External engagement in regulatory or industry forums.
- Prior experience at a health authority performing GMP inspections.
- Demonstrated ability to establish and maintain collaborative relationships with key stakeholders.
- Demonstrated ability to lead and drive results for business initiatives.
- Demonstrated ability for process improvement.
- Experience with development, implementation ,and optimization of IT tools to deliver business outcomes.

**Travel Expectation**:

- Minimum 50% travel

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

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.**

**US and Puerto Rico Residents Only**:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualifie

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