Director Quality Control

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Overview

We are seeking an experienced strategic and hands-on Head of Quality Control to lead the QC organization at the Schaffhausen manufacturing site. This role is responsible for ensuring that all QC operations consistently support GMP compliance timely product release and continuous improvement. The ideal candidate has a minimum of 10 years experience in pharmaceutical quality with demonstrated leadership of leaders (managers/senior supervisors).

Key Responsibilities

• Provide strategic leadership and direction for the site QC function aligning QC goals with site and corporate quality objectives.

• Lead develop and mentor a team of QC leaders and subject-matter experts; build bench strength and a high-performing leadership team.

• Oversee all QC laboratory operations including raw materials testing in-process testing finished product testing stability programs and method validation/transfer.

• Ensure timely and compliant batch release activities and maintain appropriate release documentation and records.

• Own QC contributions to the Quality Management System: deviations investigations CAPA change control OOS/OOT management and trend analysis.

• Prepare for and support regulatory inspections and third-party audits; ensure inspection readiness across QC.

• Establish and track KPIs for QC performance (turnaround time sample backlog OOS rates CAPA closure etc.); drive continuous improvement initiatives to meet targets.

• Manage departmental budget resources and capital requests in collaboration with site leadership.

• Partner cross-functionally with Manufacturing Quality Assurance Regulatory Affairs Engineering and Supply Chain to resolve quality issues and enable product flow.

• Champion a culture of quality safety and compliance across the site.

Minimum Qualifications

• Bachelors degree in Chemistry Pharmaceutical Sciences Life Sciences or related field; advanced degree (MS/PhD) preferred.

• Minimum 10 years of progressive experience in pharmaceutical quality and QC operations.

• Proven experience leading leaders responsibility for multiple managers/senior supervisors and large teams.

• Deep knowledge of GMP requirements and experience supporting regulatory inspections (FDA EMA MHRA or equivalent).

• Demonstrated experience in QC laboratory systems: LIMS analytical method validation/verification instrument qualification stability testing.

• Strong track record in investigations CAPA management change control and root cause analysis.

• Excellent leadership skills with the ability to influence at all organizational levels and drive cultural change.

• Strong verbal and written communication skills and experience preparing for audits/inspections.

• Willingness to work on-site;

Preferred Qualifications

• Experience in sterile manufacturing aseptic processes biologics and API.

• Training in Lean Six Sigma or similar continuous improvement methodology.

• Experience with enterprise QC systems and electronic batch release processes.

• Fluent in German and English

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