Beschreibung
IMP External Quality Assurance Manager -GMP, quality assurance and/or quality controlRole:
For our client in the Pharma industry based in Kaiseraugst we are looking for a IMP External Quality Assurance Manager.
Background: The purpose of this position is to provide operational quality assurance oversight and expertise for clients outsourced GMP operations related to clinical small molecule GMP intermediates/APIs, large molecule drug substance (MABs, peptides, oligonucleotides), small and large molecule drug products, and clinical packaging/ labelling.
Perfect Candidate: The team is looking for an experienced quality manager to backfill one of their members leaving. This person should have enough experience to be comfortable managing external vendors and manufacturers. While the team will take time to bring the contractor up to speed, they need someone with a strong background experience still (7 years in pharma, 4 of which in quality assurance/control as a minimum). Please note that this position is very likely to be extended.
Areas of responsibility:
- Represent the IMP External Quality function on Technical Development Teams, as needed, and Joint Management Teams to include CDMO Quality Systems assessments, assuring CDMO (c)GMP compliance, and tracking appropriate metrics.
- Responsible for review of Master Batch Records, executed Batch Records and any associated deviations and investigations. Ensure compliance with clinical trial protocols, regulatory filings, and product requirements.
- Ensure that manufacture and release of clinical supplies of Clients GMP intermediates, API, Drug Product, and Finished Product at CDMOs is conducted in accordance with (c)GMP.
- Participate in due diligence visits and compliance audits to assess CDMOs' Quality Systems for development and processing of investigational medicinal products.
- Prepare, negotiate and maintain Technical Quality Agreements and corresponding Product
Specific Requirements with selected CDMOs and ensure the requirements of the Quality Agreement are fulfilled.
- Build strong relationships with both internal operational functions and external CDMOs.
- Review and approve QC method validation protocols per the Quality Agreement.
- Perform quality risk assessments, develop mitigation plans and follow-up on implementation at CDMOs.
- Provide input in the design of sampling plans and product specifications for GMP intermediates, API and drug product.
- Coordinate the QC requirements between the CDMO, internal QC and or other contract testing laboratories.
- Approve CDMO analytical method transfers and method qualifications protocols/reports with internal QC.
- As needed, act as a person in the plant and provide to client oversight of the CDMO quality unit in order to facilitate timely initiation, assessment, review, and closure of discrepancies and investigations.
- Escalate gaps of audit responsiveness, CAPA implementation, deviation reporting and management, and investigation closure with regard to quality and time.
Professional and technical requirements:
- Min Master (or higher education) in Life Sciences
- Min 7 years in pharma and manufacturing (either in quality assurance and/or quality control)
- Min 4 years in a quality role
- Demonstrated proficiency in interpretations of international (c)GMP regulations
- Fluent in English
- Strong negotiation and influencing skills
- Experience with self-organized workstyle in agile teams according to `New Work´ concepts
- High individual responsibility, integrity and accountability as delegate of a Swiss Responsible Person
- Proficiency in English (and German preferred)
- Ability to travel up to 10% domestic and international
Nice to Haves:
German or another European language
Reference no: 919719 AD
Role: IMP External Quality Assurance Manager
Industry: Pharmaceutical industry
Workload: 100%
Location: Kaiseraugst, Switzerland
Start date: asap
Duration: 12 months contract, with possible extension
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.