CMO, Quality Assurance Manager
Boehringer Ingelheim
full-time
Posted on:
Location Type: Office
Location: Germany
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About the role
- Ensure business continuity with Contract Manufacturing Organizations (CMOs) by overseeing batch and product quality processes including Product Quality Reviews (PQRs), change controls, deviations, CAPAs, stability monitoring, audits, complaints, Quality Agreements (QAAs), CMO performance ratings, risk management, and product lifecycle extensions.
- Act as the Product Expert with end-to-end ownership to prevent, identify and resolve quality issues.
- Maintain regulatory compliance across the contract lifecycle by defining and tracking KPIs, leading investigations, managing audits and recalls, executing change controls, and verifying effectiveness of corrective and preventive actions.
- Promote and strengthen Quality Culture within CMOs through Quality Management Reviews, training programs, technical site visits, periodic cross-functional meetings, support for quality audits, and close collaboration with Supply Chain, CMO Management and Regulatory Affairs.
- Provide release/rejection recommendations and advise on production holds to ensure product quality and regulatory compliance.
- Manage multiple parallel priorities and conflicting topics while coordinating with internal and external stakeholders.
Requirements
- Master’s degree in Pharmacy, Chemistry or Engineering and several years’ experience in a pharmaceutical quality role within a cGMP environment.
- Expert knowledge of global quality and regulatory requirements (including FDA and EMA) and their impact on the manufacture and testing of pharmaceutical, veterinary medicinal and combination products/devices.
- Excellent interpersonal, communication and negotiation skills with proven ability to lead, motivate, influence, coach, escalate and build relationships, and to maintain oversight of multiple projects in different stages simultaneously.
- Strong analytical and problem-solving skills with the ability to operate effectively in changing situations.
- Willingness to travel nationally and internationally.
- Fluent English is required; German, French or Spanish are an advantage.
Benefits
- Applications from people with severe disabilities are warmly welcomed.
- In cases of equal qualifications, such applicants will be given preferential consideration in the selection process.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Product Quality Reviews (PQRs)change controlsdeviationsCAPAsstability monitoringauditsQuality Agreements (QAAs)KPI trackingregulatory compliancecGMP
Soft Skills
interpersonal skillscommunication skillsnegotiation skillsleadershipmotivationinfluencecoachingrelationship buildinganalytical skillsproblem-solving skills
Certifications
Master’s degree in PharmacyMaster’s degree in ChemistryMaster’s degree in Engineering