Associate Director, Quality Assurance

1000 Merck Sharp & Dohme LLC; West Point (PA); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is seeking an Associate Director to provide quality oversight and strategic leadership for Clinical Supply Chain activities across the development portfolio.

The role focuses on ensuring clinical supplies are available, fit for use, and compliant with regulatory requirements, with emphasis on cross-functional collaboration and continuous improvement across global sites.

Qualifications

• Bachelor’s Degree in Scientific Discipline with 8+ years relevant experience in pharmaceutical GMP/R&D
• Experience leading quality oversight for clinical supply chains
• Strong knowledge of cGMP in an R&D environment

Responsibilities

• Provide in-depth technical and quality expertise in clinical supply operations and Medical Device/Combination Products
• Develop and execute quality and stakeholder engagement strategies
• Evaluate and disposition materials ensuring compliance with policies and regulatory requirements
• Coordinate investigations related to deviations and significant quality events
• Identify quality trends and lead resolution of issues impacting product quality or supply chain reliability

Skills

Clinical supplies R&D

Regulatory compliance

Cross-functional collaboration

Continuous improvement

Leadership

Education

Bachelor's Degree (Science)

Advanced degree (optional)

Job description

Job Description

The Associate Director, Clinical Supplies Quality, Global Development Quality provides quality oversight, disposition support, and strategic quality leadership for Clinical Supply Chain activities supporting clinical development programs across the company’s portfolio. The role is accountable for ensuring clinical supplies are available, fit for use, and compliant with applicable regulatory requirements.

Key Areas of Responsibility

Key areas of responsibility include U.S. quality operations and disposition, global distribution planning and management, Medical Device/Combination Product supply activities, and acquisition integration.

Primary Activities

Primary Activities: This position requires close, cross-functional collaboration with key stakeholder groups, including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development & Manufacturing, and Quality Assurance sites and functions across the clinical supply chain. The role also requires the ability to navigate dynamic, high-impact, and highly visible situations to help ensure continuity of the company’s clinical development portfolio and minimize disruption related to clinical supply issues. In addition to the responsibilities outlined above, the incumbent is expected to independently lead and execute the following activities:

• Provide in-depth technical and quality expertise in clinical supply operations, integration activities, Medical Device/Combination Products, and emerging technologies.
• Develop and execute quality and stakeholder engagement strategies, as well as continuous improvement initiatives aligned with business objectives, while streamlining processes, procedures, and technology-enabled ways of working.
• Evaluate and disposition Medical Device/Combination Product materials, ensuring they are manufactured in accordance with applicable company policies, procedures, and governing regulatory requirements.
• Coordinate and/or support investigations related to deviations and significant quality events.
• Identify quality trends, potential compliance gaps, and emerging risks, and proactively lead resolution of significant issues that may impact product quality or clinical supply chain reliability.

Required Skills

• Strong technical expertise in R&D activities related to clinical supplies, with preferred experience in Medical Device/Combination Products and emerging technologies.
• Strong compliance knowledge and understanding of regulatory agency expectations, including the ability to interpret and apply cGMP requirements within an R&D environment.
• Demonstrated experience working with external partners and cross-functional stakeholders, with the ability to engage, influence, and align subject matter experts and senior leaders.
• Demonstrated knowledge of continuous improvement methodologies, with the ability to lead complex, cross-functional initiatives that improve processes, systems, and ways of working.
• Demonstrated leadership capability, including strategy development and deployment, with a track record of delivering measurable business, quality, or operational benefits.

Preferred Skills

• Preferred experience in Medical Device/Combination Products and emerging technologies.

Required Education/Experience

• Bachelor’s Degree in Scientific Discipline with 8+ years relevant experience within the pharmaceutical industry or Good Manufacturing Practice (GMP) related field (including Technical, Engineering, Quality or Operations) or advanced Degree with 6+ years relevant experience.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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

Location and Salary

The primary location for this posting is: USA - Pennsylvania - West Point.

Where required by law, the compensation range for this role is provided below.

$129,000.00 - $203,100.00

The salary range for the primary location of this role is: $129,000.00 - $203,100.00. If a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Additional Location(s) Compensation

Additional location(s): Please note the salary range above applies to the Primary Location of the position.

Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Employee Status

Employee Status: Regular

Relocation

Regular Relocation: No relocation

Visa Sponsorship

Visa Sponsorship: No

Travel and Flexibility

Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A

Search Firm Representatives

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.