Quality Assurance Product Lead

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

Do you thrive at the intersection of quality, compliance, and customer collaboration? Join a team where you’ll be the trusted QA lead driving success for critical pharmaceutical projects.

R&D Partners is seeking a Quality Assurance Product Lead to join a pharmaceutical company in Switzerland. This role offers an exciting opportunity to lead technical quality assurance efforts for client projects, ensuring compliance with GMP requirements and regulatory standards across the product lifecycle.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Serve as the primary Technical Quality Assurance representative for client projects, providing subject matter expertise and acting as the 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.

Key Skills and Requirements:

• Bachelor’s or Master’s degree in Biochemistry, Biotechnology, Pharmacy, or another relevant life sciences discipline.
• Minimum of 8 years of experience in a Technical Quality Assurance role within a GMP-regulated pharmaceutical or biotechnology environment.
• Proven 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.
• Experience in sterile pharmaceutical production or injectable drug product manufacturing is a significant advantage.
• Excellent understanding of quality and compliance requirements across the product lifecycle, with the ability to apply technical QA expertise to complex manufacturing and development activities.
• Strong stakeholder management and cross-functional collaboration skills, with the ability to work effectively with customers, manufacturing, QC, and regulatory teams.

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