Hobson Prior are looking for a Senior QA Manager - Drug Substance to join a growing biopharmaceutical company in Switzerland, who focus on discovering, developing and bringing more pioneering medicines to patients.
- Deliver GMP/GDP quality assurance expertise during development and later during commercialization of the organisation’s products.
- Complete GMP onsite audits at Contract Manufacturing Organizations.
- 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.
- Provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions for assigned projects.
- Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.
- Excellent interpersonal and influencing skills.
- Strong verbal and written communication skills in English.
- Ability to manage multiple tasks with competing priorities.
- Entrepreneurial mind set combined with cost consciousness.
- Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree.
- Minimum of 3 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.
- Minimum of 3 years’ experience in quality assurance activities specific to drug substance.
- Excellent knowledge of GMPs and regulatory environments, ability to interpret and implement quality standards.
- Prior experience in SAP is required.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.