Director Quality Control

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Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Schaffhausen, Switzerland

Job Description:

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

• Bachelor's 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

Required Skills:

Preferred Skills:

Compliance Management, Consulting, Corrective and Preventive Action (CAPA), Human-Computer Relationships, Performance Measurement, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Researching, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility

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