Associate Director Quality Assurance (m/f)-QUA008585
Description
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 on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our research division is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
We are looking for an Associate Director, Quality Assurance, supporting our Integrated Project Team (IPT) for Biologics focusing on the quality support for manufacturing and testing of Biologics, and clinical release of biological Drug Substances and sterile Drug Products at WAG.
The role includes responsibilities for compliant evaluation and implementation of cutting edge technologies, development of procedures and best practices supporting for the global organization and the WAG site. The incumbent will interact with global and local stakeholders, exercise leadership in monitoring and maintaining compliance with worldwide regulatory requirements, current Good Manufacturing Practices (cGMPs), Quality Manual, and pertinent legal and / or business contract requirements. Key responsibilities may include leading deviation investigations, change requests, upskilling employees for Quality, Compliance and Regulatory improvements, and interfacing with other MSD sites. The incumbent will assist the IPT Biologics Associate Director in interfacing with site and global groups, including other Quality groups.
The primary activities include but are not limited to:
Acts as Quality leader in global and local teams for evaluation and implementation of new technologies
Takes responsibility for timely release of clinical Biologics (DS, sterile DP, and secondary packaged clinical supplies)
Manufacturing Batch Record Review of Biologics (DS, sterile DP, and secondary packaged clinical supplies)
Closely collaborates with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place
Serves as a point of contact for issue resolution and liaises with other functions locally and globally
Supports investigations and changes in related stakeholder areas
Supports equipment qualifications and computer system validations in related stakeholder areas
Conducts Walkthrough Audits and Internal Audits / Supports the Quality on the Floor program
Supports analytical method validations (incl. microbiological testing) for in-house and outsourced analytical testing
Tracks and monitors local operational and quality performance. Escalates issues to the IPT Biologics Quality Associate Director as appropriate
Qualifications
Advan ced degree in Biotechnology, Microbiology, or Chemistry
Min. 7 years’ experience in Quality, Technical Operations, related Business Operations or GMP regulated environment, including experience in manufacturing of Biologics and Steriles
Possesses the following:
Demonstrated Quality or Manufacturing experience in the areas of pharmaceutical and / or sterile biologics manufacturing or packaging
Ability to work within a global matrix organization and leverage expertise from other functions and departments
Demonstrated problem-solving skills
Proven self-starter
Strong understanding of regulatory agency regulations and requirements coupled with proficiency in interpreting and applying cGMPs to R&D environment, including data management, collection, and analysis
Possesses excellent interpersonal, inclusion, and communication skills; demonstrated successful opinion leaders’ management
Comprehensive Lean Six Sigma and Project Management skills; ability to lead matrix teams, recognize improvement opportunities, develop appropriate solutions and follow through on implementation
Ability to communicate to senior management and successfully interact with local and global stakeholders
Appreciates and respects diversity, cultures, and norms in a team
Works independently within Quality
Drives results
Escalates issues / concerns to management, as appropriate
Ability to independently management multiple priorities and projects, align and simplify
German & English proficiencies, excellent verbal and written communication and presentation skills
Occasionally traveling needed (10%)
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.
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.
