Sanofi Group Quality Manager - Finished Goods in Waltham, Massachusetts
The Quality Manager - Finished Goods 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).
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.
Minimum 8 years pharmaceutical / biotechnology industry experience.
Demonstrated success in working cross-functionally in a matrix organization
Minimum 4 years’ experience within a Quality role.
Experience with biologics drug substance manufacturing processes
Experience working with external partners (e.g. CMOs, contract laboratories and suppliers)
Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
Competencies/Other Skills: ·
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
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.
- Sanofi Group Jobs