Associate Director, Quality Assurance

Merck•Upper Gwynedd Township, PA

48d•$129,000 - $203,100•Hybrid

About The Position

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 include U.S. quality operations and disposition, global distribution planning and management, Medical Device/Combination Product supply activities, and acquisition integration. The position works closely with Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development & Manufacturing, and Quality Assurance sites and functions throughout the clinical supply chain. It requires navigating dynamic, high-impact, and highly visible situations to help maintain continuity of the clinical development portfolio and minimize disruption related to clinical supply issues. The incumbent independently provides technical and quality expertise in clinical supply operations, integration activities, Medical Device/Combination Products, and emerging technologies. The role develops and executes quality and stakeholder engagement strategies and continuous improvement initiatives aligned with business objectives, including streamlining processes, procedures, and technology-enabled ways of working. It evaluates and dispositions Medical Device/Combination Product materials, coordinates or supports investigations into deviations and significant quality events, and identifies quality trends, compliance gaps, and emerging risks while leading resolution of significant issues that could affect product quality or clinical supply chain reliability.

Requirements

Bachelor’s degree in a scientific discipline and 8+ years of relevant experience within the pharmaceutical industry or a GMP-related field, including technical, engineering, quality, or operations; or an advanced degree and 6+ years of relevant experience.
Strong technical expertise in R&D activities related to clinical supplies.
Strong compliance knowledge and understanding of regulatory agency expectations, including the ability to interpret and apply cGMP requirements in an R&D environment.
Demonstrated experience working with external partners and cross-functional stakeholders, and ability to engage, influence, and align subject matter experts and senior leaders.
Knowledge of continuous improvement methodologies and ability to lead complex, cross-functional initiatives that improve processes, systems, and ways of working.
Leadership capability, including strategy development and deployment, with a track record of delivering measurable business, quality, or operational benefits.
Skills in deviation management, process implementations, product compliance, project leadership, project risk assessments, quality oversight, quality risk management, regulatory compliance, stakeholder management, standards compliance, strategic leadership, and strategy development.

Nice To Haves

Experience in Medical Device/Combination Products and emerging technologies.

Responsibilities

Provide quality oversight, disposition support, and strategic quality leadership for Clinical Supply Chain activities supporting clinical development programs.
Support U.S. quality operations and disposition, global distribution planning and management, Medical Device/Combination Product supply activities, and acquisition integration.
Collaborate with Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, External Development & Manufacturing, and Quality Assurance sites and functions.
Provide 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 and continuous improvement initiatives aligned with business objectives.
Streamline processes, procedures, and technology-enabled ways of working.
Evaluate and disposition Medical Device/Combination Product materials to ensure they are manufactured in accordance with company policies, procedures, and applicable regulatory requirements.
Coordinate and/or support investigations related to deviations and significant quality events.
Identify quality trends, potential compliance gaps, and emerging risks, and lead resolution of significant issues that may affect product quality or clinical supply chain reliability.
Navigate high-impact situations to help ensure continuity of the clinical development portfolio and minimize clinical supply disruption.