Associate Director, Quality Assurance

About the role

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

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.

#eligibleforERP

Required Skills

Deviation Management, Process Implementations, Product Compliance, Project Leadership, Project Risk Assessments, Quality Oversight, Quality Risk Management, Regulatory Compliance, Stakeholder Management, Standards Compliance, Strategic Leadership, Strategy Development

Preferred Skills

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US and Puerto Rico Residents Only

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

Pay and benefits

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

The salary range for the primary location of this role is

$129,000.00 - $203,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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): 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. 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.

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

• 10%
• Flexible Work Arrangements: Hybrid
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): N/A
• Job Posting End Date: 11/10/2026

Additional information

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.