Senior QA Manager - GMP
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Senior QA Manager for 6 months contract based in Basel area.
The ideal candidate should have 3 years of experience in quality assurance activities as well as sound knowledge of GMP and regulatory environments.
- Provide GMP/GDP quality assurance expertise during development and later during commercialization of the products;
- Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team;
- Write, review, and/or approve internal SOPs and other GMP/GDP related documentation;
- Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards;
- Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle;
- Manage all required activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls;
- Notify management of potential quality and regulatory issues;
- For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed;
- Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.
Qualifications and Experience:
- Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree;
- Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry;
- Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards;
- Strong interpersonal and influencing skills;
- Excellent verbal and written communication skills in English;
- Ability to manage multiple tasks with competing priorities;
- Entrepreneurial mind set combined with cost consciousness;
- Relevant working/residency permit or Swiss/EU-Citizenship required.