Director, Quality Control

Job Summary
The Director, Quality Control (QC) provides strategic and operational quality oversight of all QC activities supporting development, manufacture, testing, release, and lifecycle management of small molecule, biologic/large molecule, and combination products. Serves as a QC technical authority for analytical control strategies, method performance, reference standards, specifications, and laboratory investigations in compliance with global GxP and internal Quality Systems.

Essential Duties & Responsibilities
- Provide quality/technical oversight for QC testing (raw material, in-process, release, stability, special testing) across product types.
- Act as primary quality escalation point for critical QC compliance issues.
- Oversee and approve Laboratory Investigations (OOS, OOT, deviations, atypical results, data integrity events); ensure risk-based, trended, CAPA-supported closure.
- Trend QC events; identify and address systemic issues.
- Establish lifecycle management for reference standards/critical reagents with Analytical Development (qualification, potency assignment, requalification).
- Oversee global stability program (protocol input/approval, execution oversight, data review/interpretation, trends/reporting).
- Oversee annual product quality reviews tied to QC data.
- Ensure CoA generation/review/approval for clinical/commercial materials (data integrity, specification compliance, regulatory alignment).
- Lead specification management and collaborate with Pharmaceutical Sciences; partner with Regulatory Affairs on submissions/variations.
- Oversee analytical method validation/verification, lifecycle management, and transfers; ensure compliance across external testing sites.
- Lead/support QC lab audits and regulatory inspections as a QC SME; ensure commitments are addressed.
- Ensure QC processes are defined in the QMS (SOPs, training, change control, risk management).
- Drive continuous improvement; provide QC metrics/trends/risk to Quality forums.
- Mentor QA staff; support selection/qualification/oversight of external QC labs and CMOs.

Experience & Qualifications
- MS/PhD preferred in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or related.
- 12+ years pharmaceutical/biotech quality experience, including QC, QC QA oversight, and/or analytical sciences.
- Experience with small molecule, biologics, and/or combination device programs.
- Strong knowledge of FDA, EMA, ICH, and EU GMP for lab operations.
- Experience with regulatory inspections and implementing risk management for QC compliance.
- Statistical analysis of analytical data; strong analytical/scientific judgment.
- Deep understanding of laboratory investigations and data integrity.
- Strong organizational, communication, negotiation, and presentation skills.
- Ability to work cross-functionally and independently in remote settings.