IMP External Quality Assurance Manager (m/f)

REFERENCE NUMBER:

382932/29

MY DUTIES:

-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 Quality Agreements and corresponding Product Specific Requirements with selected CDMOs and ensure the requirements of the Quality Agreement are fulfilled (in collaboration with other quality functions)
-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, product requirements and (c)GMP compliance
-Provide technical subject matter expertise and guidance by supporting or managing deviations and investigations, changes, specifications and regulatory submissions
-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
-Ensure that manufacture and release of clinical supplies of small molecule intermediates, API and Drug Product, and Finished Product at CDMOs is conducted in accordance with (c)GMP
-As needed, act as a person in the plant and provide oversight of the CDMO quality unit in order to facilitate timely initiation, assessment, review, and closure of discrepancies and investigations

MY QUALIFICATIONS:

-MSc/PhD in life sciences or equivalent
-Profound experience in pharmaceutical manufacturing, quality assurance and/or quality control
-Profound experience in a quality role
-Demonstrated proficiency in interpretations of (c)GMP regulations
-Strong negotiation and influencing skills
-Ability to travel up to 20% domestic and international
-Proficiency in English (and German preferred)

MY BENEFITS:

-A very renowned company
-You will work in an international environment
-A city with a high quality of life that perfectly embraces both modern and traditional values

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Svenja Weiß

Reference number
382932/29

Contact
E-Mail: [email protected]