QA Product Lead: GMP, Compliance & Pharma Expert

R Dpartners; Oberwallis; On-site; CHF 120,000 - 180,000; Full time

Job summary

R Dpartners is seeking a Quality Assurance Product Lead to join a pharmaceutical company in Switzerland. You will lead technical QA efforts across the product lifecycle, ensuring GMP compliance and regulatory standards.

You will collaborate with customers and cross-functional teams, review quality documentation, support audits, and help drive quality improvements in sterile manufacturing and drug product operations.

Qualifications

• Minimum of 8 years in a Technical Quality Assurance role within a GMP-regulated pharmaceutical or biotechnology environment.
• Experience supporting drug product manufacturing, with exposure to aseptic processing and sterile manufacturing operations highly preferred.
• Strong working knowledge of GMP regulations, quality systems, and pharmaceutical manufacturing processes.
• Excellent understanding of quality and compliance requirements across the product lifecycle.

Responsibilities

• Serve as the primary Technical Quality Assurance representative for client projects and main point of contact for quality-related matters.
• Provide proactive QA oversight during all stages of product development and manufacturing, ensuring adherence to GMP regulations and internal quality standards.
• Review, assess, and approve product quality documentation, including deviations, CAPAs, change controls, and other quality records.
• Lead the establishment, negotiation, and maintenance of Quality Agreements with customers, defining clear quality and compliance responsibilities.
• Support analytical method transfers, qualification, verification, and validation activities by offering technical QA guidance and collaborating with cross-functional teams.
• Prepare, issue, and maintain batch documentation, including batch records and labels, while providing expertise during batch record review and disposition activities.
• Act as the technical quality subject matter expert during customer audits and regulatory inspections, supporting inspection readiness and responses to audit observations.

Skills

GMP regulations

Quality systems

Cross-functional collaboration

Stakeholder management

Audit readiness

Education

Bachelor’s or Master’s degree in life sciences

Job description

R Dpartners is seeking a Quality Assurance Product Lead to join a pharmaceutical company in Switzerland. You will lead technical QA efforts across the product lifecycle, ensuring GMP compliance and regulatory standards.

You will collaborate with customers and cross-functional teams, review quality documentation, support audits, and help drive quality improvements in sterile manufacturing and drug product operations.