Quality Manager - Pharmaceutical

About the role

CK QLS is recruiting a Quality Manager for a pharmaceutical company in Allschwil on a 12-month contract. Working within Technical Operations – Global Quality Management, you will provide GMP/GDP quality oversight across product development, manufacturing and commercialization. The role suits an agile, independent quality professional who can integrate quickly and take ownership in a dynamic environment.

Key responsibilities

• Provide GMP/GDP quality assurance expertise throughout the development and commercialization of pharmaceutical products.
• Ensure quality activities follow the relevant development stage and applicable quality standards.
• Guide the resolution of complaints, deviations, OOS results and investigations, supporting CAPA.
• Establish and maintain risk-based quality approaches throughout the product lifecycle.
• Support the release of active ingredients, commercial products and investigational medicinal products, including master documentation approval, batch record review and change control assessment.
• Represent Quality in CMC team meetings and communicate quality, regulatory and supply timeline issues.
• Prepare GMP/GDP quality agreements with contract manufacturers and internal stakeholders.
• Write, review and approve SOPs and other GMP/GDP documentation.
• Contribute to improvements in the pharmaceutical quality system, including monitoring CMO performance.
• Release drug substance and drug product bulk in accordance with relevant procedures.

Required profile

• Master's degree or higher in Pharmacy, Chemistry or a relevant scientific or technical discipline.
• 3-6 years' experience in pharmaceutical operational activities such as product development, quality control, analytical development or chemical production.
• 3-6 years' experience in Quality Assurance for drug substance and/or drug product.
• Fluent English and at least basic knowledge of another language; German or French would be advantageous.
• Work permit or eligibility to work in Switzerland.
• Previous experience supporting pharmaceutical manufacturing and commercial products is highly desirable.

Required skills

• Strong understanding of pharmaceutical development, manufacturing, quality control, packaging and distribution.
• Good working knowledge of cGMP/GDP and the ability to interpret and implement quality standards.
• Organizational, communication and influencing skills, with the ability to manage complex projects and competing priorities.
• Proactive, independent approach and confidence working with cross-functional stakeholders.

To apply, send your CV to the consultant handling the search, outlining your relevant experience and availability.