Quality Manager
CK QLS is recruiting for a Quality Manager to join 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. This is an opportunity for an agile, independent quality professional who can integrate quickly and take ownership in a dynamic environment.
Your responsibilities
- Provide GMP/GDP Quality Assurance expertise throughout the development and commercialization of pharmaceutical products.
- Ensure quality activities are completed in line with the relevant development stage and applicable quality standards.
- Guide the resolution of complaints, deviations, OOS results and investigations, supporting appropriate 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 potential quality, regulatory and supply timeline issues.
- Prepare GMP/GDP quality agreements with contract manufacturing organizations 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.
- A 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.
- 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.
- Strong organizational, communication and influencing skills, with the ability to manage complex projects and competing priorities.
- A proactive, independent approach and confidence working with cross-functional stakeholders.
- Fluent English and at least basic knowledge of another language; German or French would be advantageous.
- Previous experience supporting pharmaceutical manufacturing and commercial products would be highly desirable.
To apply or find out more or apply, please send your CV to Rob Angrave at CK QLS, outlining your relevant experience and availability.
All applicatonat must have a work permit or be eligble to work in Switzerland.