Associate Director, Quality Assurance

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 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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