Supervisor, External Quality Assurance

As part of the Quality Assurance team supporting a multi-product CDMO facility, the Supervisor is responsible for identifying and assessing regulatory and quality risks associated with the production of biological drug substances and related quality systems. This position provides leadership and oversight for quality support of new product introduction, client-facing quality activities, document review and approval, inspection readiness, and continuous improvement initiatives.

Duties and Responsibilities

• Supervise, coach, and develop External Quality Assurance personnel, including work assignment, training, performance feedback, and prioritization of departmental deliverables
• Serve as the primary escalation point for complex quality issues within the function and ensure timely resolution of quality events, client requests, and cross-functional action items
• Provide Quality oversight and act as a key point of contact between the QA organization and customers for assigned programs and quality matters
• Represent the Quality organization on collaborative cross functional program teams and drive alignment on quality expectations, deliverables, and timelines
• Review and approve documents, records, and reports related to new product introduction, including master batch records, specifications, protocols, reports, and associated quality documentation
• Serve as a Subject Matter Expert for Quality support of new product introduction, technical transfers, and lifecycle quality activities
• Lead or support the development, revision, review, and approval of Standard Operating Procedures and related quality system documents
• Monitor quality metrics, identify trends, and drive continuous improvement initiatives
• Provide leadership for training within the function and ensure personnel are qualified and effective
• Support inspection readiness activities and participate in client audits, regulatory inspections, and internal assessments
• Assess the adequacy, logic, and effectiveness of quality systems and recommend improvements

Qualifications

• Bachelor's Degree in STEM or related discipline
• 7+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry
• Prior experience leading, mentoring, or coordinating the work of others in a quality environment
• Strong knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environment
• Strong knowledge of manufacturing processes and the impact of deviations, changes, and quality events on product quality and compliance
• Demonstrated ability to make sound, risk-based quality decisions and escalate issues appropriately
• Experience in electronic quality systems including advanced data mining, reporting, and query building
• Strong interpersonal skills, organizational skills, and attention to detail
• Strong verbal and written communication skills with the ability to manage multiple priorities in a dynamic environment
• Microsoft Office – Outlook, Word, Excel

Preferred Qualifications

• Professional Quality certifications a plus (CQA, CQE, CQM, RABQSA)
• Prior experience in an external quality role within a CDMO or biologics manufacturing environment is preferred
• Experience supporting customer-facing quality activities, audits, and regulatory inspections
• Experience with change control, deviation management, CAPA, and quality risk management is preferred
• Advanced Excel and data analysis skills are a plus