Head of Quality Assurance Operations (Drug Product)

Main Responsibilities:
- Lead the Drug Product Quality Assurance team with quality oversight of the entire drug product manufacturing process at the Sanofi Swiftwater Site.
- Provide quality leadership and direction for sterile drug product manufacturing (Formulation, Filling, Inspection, Packaging, Release, Distribution).
- Oversee batch review and prepare batch disposition for intermediates and finished goods in the area (final accountability under the QP or equivalent).
- Ensure readiness for inspections by implementing applicable specific requirements for regulated areas.
- Develop and implement annual Quality Assurance operation objectives and quality operation procedures.
- Maintain systems to identify, track, and mitigate compliance and quality risks.
- Ensure timely closure of quality events (deviations, CAPAs, change controls).
- Oversee manufacturing validation status and adherence to SOPs.
- Establish and monitor KPIs and quality metrics (e.g., deviation closure, batch review cycle time, CAPA effectiveness, batch quality trends, right-first-time, OOS/OOT).
- Promote a culture of quality and lead continuous improvement initiatives.
- Evaluate and recommend new technologies, tools, and methods to improve QA operations.
- Lead management reviews to assess QA effectiveness.
- Lead and manage the QA operations team (hiring, training, coaching, development, performance evaluation).
- Ensure cross-functional collaboration (Regulatory Affairs, Supply Chain, Manufacturing leadership, and other Quality functions).
- Serve on the Site Quality Leadership team and represent Quality in the Drug Product Manufacturing Ecosystem.

Key involvement in decision making:
- Review and prepare manufacturing documentation for batch disposition.
- Define initiatives to improve QA processes/systems.
- Identify and escalate quality alert risks.
- Support quality control processes and improvements.
- Follow progress on quality improvement projects and implement remediation from internal/external audit findings.

Requirements/Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 10+ years QA experience in the pharmaceutical industry.
- 5+ years in people leadership.
- 5+ years sterile/aseptic drug product manufacturing experience.
- Proven ability to present/defend quality topics in regulatory inspections (e.g., FDA/EMA).
- Preferred: ASQ, CQE, Six Sigma.

Skills/Knowledge:
- Strong GMP and QA principles.
- Ability to analyze complex data; identify trends, root cause, issues, and solutions.
- High attention to detail; strong verbal/written communication.
- Problem-solving and effective corrective action implementation.
- Project management (multiple priorities) and structured problem-solving.
- Expertise in root cause analysis techniques.
- Fluent English (spoken/written).
- Drug product operations knowledge (formulation/filling using RABS and isolators, manual/automated visual inspection, packaging incl. labeling/serialization, and release requirements).
- Ability to lead/influence; high autonomy; strong computer literacy (Excel, PowerPoint, Word).