Associate Director, Commercial Product Quality – External Supply Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the commercial product quality team to establish and execute the quality management process, ensuring compliance with regulatory requirements and BeOne standards for product quality.

• Responsible for overseeing BeOne qualified Contract Manufacturing Organizations (CMOs) within the US, including managing performance, evaluating trends, and implementing necessary remediation.

• Act as the primary escalation point for quality managers at CMOs.

• Review and authorize change control strategies for modifications notified by CMOs.

• Evaluate and approve Annual Product Quality Review (APQR) reports provided by CMOs manufacturing BeOne products.

• Lead the handling of batch-related deviations, ensuring thorough investigations and the effective implementation of Corrective and Preventive Actions (CAPA) at CMOs.

• Conduct or supervise the Person in Plant (PIP) activities.

• Manage inspection capabilities within the team to guarantee successful outcomes for inspections hosted by CMOs or BeOne, such as Pre-Approval Inspections (PAIs) and Pharmacovigilance inspections.

• Ensure that quality processes align with Health Authorities' expectations and continuously enhance them by promptly addressing related regulatory changes.

• Provide guidance and support for the development, implementation, and updates of Quality Agreement content.

• Collaborate cross-functionally with departments such as Manufacturing, Supply Chain, Regulatory CMC, and other Quality teams, including Qualified Persons (QPs) in the EU.

• Ensure quality support for product commercial supply, including timely batch releases.

• Assist with product recalls in the commercial supply chain as necessary.

• Execute other tasks as assigned in compliance with Standard Operating Procedures (SOPs), regulatory agencies, and Good Practice (GxP) guidelines.

• Collaborate with cross-functional partners to establish Process Performance Qualification for Small Molecule products.

• Draft Standard Operating Procedures pertinent to the function and department.

⛳️ Requirements

• Bachelor of Science degree in a relevant scientific discipline or technical field such as Pharmacy, Biology, Chemistry, or Engineering.

• Minimum of 8 years of experience in quality within the pharmaceutical or biotechnology industry is required.

• A Master’s degree and at least 6 years of experience is preferred.

• At least 4 years of management experience.

• Strong computer skills are essential; proficiency in MS Office (Outlook, Word, Excel, PowerPoint) is required.

• Extensive Good Manufacturing Practice (GMP) experience in quality and manufacturing functions for both small and large molecules.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness