The QC Manager is responsible for the planning and operational aspects of cGMP in-process, release, and stability testing performed by Quality Control (QC) at contract laboratory organizations (CLO). The candidate will ensure compliance and support of company Quality Standards, Guidances and SOPs as well as ICH and FDA guidelines. S/he must be proficient in understanding Quality System requirements and apply that knowledge in coaching and continuous improvements of systems cross-functionally. This individual ensures adherence to all regulations and licenses pertaining to Bioverativ products, and serves as a subject matter expert to multiple disciplines. The QC Manager routinely liaises with key personnel at contract laboratories and manages implementation of change controls impacting Bioverativ products and/or testing per the Quality Agreement in place between both parties.
Forecasts testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
Manages inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
Maintain list of approved test sites per product, methods performed/site, regulatory approvals per testing site
Manage department and project metrics, as appropriate
Perform Bioverativ oversight of procedure and document changes at CLOs
Represent Bioverativ Quality as project lead for projects at CLOs, as assigned
Perform project lead responsibilities for various internal projects
Support QC LIMS activities and CoA issuance
Proactively identify technical gaps and areas for improvement related to quality or process and implement solutions
Routinely work with CMO/CLOs to ensure timelines are met for release and testing of product
Travel to CLOs to support Bioverativ products, as needed
Participate in routine internal and external Operations Meetings
Comply with Company Safety Program, including Health and Safety regulations and OSHA requirements
BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical / biotechnology industry.
Demonstrated success in working cross-functionally in a matrix organization; minimum 4 years' experience within a Quality role.
Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers); LIMS experience preferred.
In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment.
Demonstrate leadership capabilities, but also the ability to actively listen and influence in a matrix organization.
OTHER SKILLS/ COMPETENCIES:
Possess strong organizational skills with ability to multi-task and coordinate multiple activities in parallel.
Excellent oral/written communication, computer, presentation, and skills.
Manage through ambiguity, work independently and prioritize workload with minimal direction
Exude a passion for relationship building both inside and outside the company
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Apply on company website