This position provides quality oversight of cGMP activities act Contract Manufacturing Organizations (CMOs). This individual works within a cross functional team and is responsible for oversight of process performance qualification, technology transfers, PAI readiness, investigations, change controls, product disposition and ensuring compliance with Bioverativ Quality Management Systems and regulatory requirements, as needed. Role may require some travel both domestic and international.
- Provide quality oversight of cGMP external drug substance manufacturing operations
- Provide quality guidance and support for investigations and change controls
- Provide support of process performance qualification activities including document review and approval
- Provide support of product stability programs including document review and approval
- Perform review/approval of master production records, executed batch records and disposition of product
- Provide quality support for clinical and commercial technology transfers to CMOs
- Provide support of Bioverativ Quality Management Systems, as needed – e.g. product quality reviews, data compilation and analysis, audits, risk program
- Provide PAI readiness support including on-site support of CMOs, as needed
- Travel, as needed to CMOs to support Bioverativ products
- Participate in routine internal and external Operations Meetings
- Escalate quality and compliance issues to quality management
- Bachelor's degree is required
- A minimum 4 years experience in the pharmaceutical / biotechnology industry within a Quality role.
- Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)
- Experience with biologics drug substance manufacturing processes
- Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
- Position/Role may require some travel both domestic and international.
- A Masters' degree is preferred
OTHER SKILLS/ COMPETENCIES:
- Demonstrated success in working cross-functionally in a matrix organization
- Demonstrate strong leadership capabilities, but also the ability to actively listen
- Ability to influence in a matrix organization
- Manage through ambiguity, work independently and prioritize the workload with minimal direction
- Exude a passion for relationship building both inside and outside the company
- Demonstrate excellent communication skills both internally and externally
- Ability to multi-task and work in a fast paced and dynamic environment
Bioverativ, a Sanofi company, is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 as an independent company spun out of Biogen's hemophilia business, we build upon a strong heritage of scientific innovation and are committed to actively working with the rare blood disorders community. The company's mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in more than two decades. For more information, visit www.bioverativ.com or follow @bioverativ on Twitter.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. VEVRAA Federal Contractor
We Request Priority Protected Veteran and Disabled Referrals for all our locations.
Bioverativ is an E-Verify Employer in the United States.
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.
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