MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD is seeking a Head of Quality Operations Europe to coordinate all activities across our external Biologics/ Vaccines Organization for the continuous improvement of operations in Europe within our Biologics Quality Operations External Manufacturing (BQOEM) group, in close collaboration and alignment with other Quality functions of the MSD pharmaceutical division (Steriles, Small Molecules, etc.).
The Director, Quality Operations Europe BQOEM will report to the Head of BQOEM and oversee/manage existing and future external manufacturers in Europe and will have the full responsibility to coordinate all relevant activities and alignment needs with other company Quality functions. With a sound strategic focus you will be responsible for building and maintaining relationships with a growing number of CMOs in Europe.
Main responsibilities include but are not limited to:
- Quality Operations with the focus of performance management, stabilization and optimization: batch disposition, compliance of global systems of pharma QS, document control, audit management
- Quality Knowledge Management: this includes BQOEM/ Biologics Manufacturing Quality Council, Quality Metrics, Quality Goals & KPIs, coordination and alignment with other Quality functions, Quality Knowledge Management
- Quality Operations (produce, assess, release): Quality Review Board, Health Authority Notifications, Recalls, CAPA, Change Control
- Quality Site Support (centralized support for CMOs): Quality Risk Management, Investigations, Annual Product Quality Report, Global Standard Procedure Implementation, Inter Company Quality Agreements, Inspection Management
- Quality Validation: CMO Facility-, Utility-, Equipment Qualification evaluation, CMO cleaning validation, MSD Product-specific qualification, Global shipping validation, process validation including relevant deviations & change controls
- Manage a virtual team of quality specialists
- Master's degree in Biology, Biotechnology, Biochemistry, Chemistry, Engineering, Microbiology or another relevant scientific or engineering discipline; advanced degree is preferred
- At least 10 years of experience directly related to Quality Business
- At least 5 years of significant leadership experience directly related to Biologics Quality Business
- Demonstrated strong leadership and problem solving skills; decisive in ambiguous environment
- Strong understanding of cGMPs, including FDA, EMEA and further relevant regulations
- Strong analytical skills and sound knowledge of biologics
- Strategic thinking with the ability to visualize the way forward, identifying opportunities that add value to the work and proactively mitigate
- Demonstrated ability to work collaboratively in team settings, across divisions, and within matrix organizations to achieve objectives
- Proven ability to multi-task, prioritize, focus on and obtain business results
- Sensitive to diverse culture; ability to use network and/or knowledge and expertise in biologics operations to drive results and business outcomes
- Excellent interpersonal, collaboration, and negotiation skills; refined communication skills and ability to be a face of MSD to the external party
- High ethical standards, being a role model of business compliance and integrity
- Willingness to travel frequently in Europe
- Fluency in English, both oral and written, German language skills advantageous
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
Job: Qual Assurce - 3rd Party Manuf Job Title:Dir, External Quality