Senior Manager, Supply Chain Quality Assurance

📋 Description

• Oversee and manage quality processes related to packaging, labeling, distribution, and Qualified Person (QP) oversight for both clinical and commercial supplies.

• Conduct batch record review and disposition activities for clinical and commercial supplies.

• Coordinate and manage Quality Events (such as Deviations and CAPAs) with Contract Manufacturing Organizations (CMOs) and escalate issues to QA management as necessary.

• Review and approve labeling artwork for both clinical and commercial products.

• Collaborate with the Clinical Trial Supply organization to establish a schedule and strategy for packaging and release activities, including QP oversight.

• Assist the QA team during internal and external GMP/GDP audits.

• Compile metrics related to Quality.

• Lead and support field-related activities such as handling complaints, Field Alerts, recalls/withdrawals, and notifications to regulatory agencies.

• Draft and review Standard Operating Procedures.

• Gather metrics on Batch Disposition, deviations, and CAPAs as applicable.

⛳️ Requirements

• Bachelor’s degree in Chemistry, Engineering, or any scientific discipline.

• 12 years of relevant experience within a GMP environment, including Drug Substance, Drug Product, Packaging, and Labeling.

• Preference for solid dosage experience, although experience in other dosage forms is acceptable.

• Previous experience with Electronic QMS systems, with Veeva being preferred.

• In-depth knowledge of FDA, EMA, and ICH standards and regulations.

• Familiarity with Risk Assessment and Root Cause Analysis methodologies (such as 5 WHYs and FMEA).

• Capacity to organize and thrive in a fast-paced environment.

• Proven ability to work independently as well as collaboratively within a team.

• Working knowledge of relevant manufacturing equipment and operations.

• Proficient in Windows and MS Office applications (Outlook, Word, Excel, PowerPoint).

• Required knowledge of software such as e-QMS (e.g., Veeva), ERP systems, Interactive Response Technology (IRT) for Clinical Supplies, and Serialization.

🏝️ Benefits

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401k match.

• Comprehensive health insurance plans (medical, dental, vision, basic life insurance) available for employees and their families.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Winter company shutdown.