Director Quality- Drug Substance
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.
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HEALTH AND WELLNESS PROGRAMS
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Employer matching because Sanofi invests in their employees!
Sanofi is eager to further your development and expertise in an ever challenging environment.
Sanofi understands the importance of family. We offer a variety of support including maternity/paternity leave.
PAID TIME OFF
Enjoy 3 weeks’ vacation and paid holidays, including company shutdown at the end of every year!
Importance of life outside of the office is valued at Sanofi.
The Director of Supplier Quality manages a team responsible for providing quality oversight of cGMP activities at Contract Manufacturing Organizations (CMOs) and service providers used to manufacture, package and distribute clinical and/or commercial product. This individual is part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. Activities include oversight of process performance qualifications, technology transfers, pre-approval inspection readiness at contract sites, investigations, change controls, and batch disposition. The Executive Director of Supplier Quality provides strategic leadership, direction, and is responsible for fostering a culture of quality and continuous improvement. Role requires some travel both domestic and international.
Ensure that functional areas of responsibility are staffed, organized, and resourced to ensure GxP obligations are fulfilled
Provide leadership, guidance and direction to staff consistent with GxP and company quality governance
Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action
Collaborate with senior management, peers and team to establish priorities that are aligned with business objectives
Provides expert input into quality issues associated with ongoing operations, projects, and programs; demonstrate knowledge of biologics manufacturing and testing requirements in an evolving regulatory environment
Identify quality improvement opportunities and implement solutions
Provide input into the department budget (forecasting, headcount allocation, spending), as required
Interface with external regulatory agencies as required
Represent Bioverativ quality management during internal and external audits and inspections
Travel to CMOs to support Bioverativ products, as needed
Participate in routine internal and external Operations Meetings
Provide pre-approval inspection readiness support including on-site support of CMOs, as needed
Develop and maintain positive relationships and network effectively across functional areas
Establish/maintain key performance indicators (KPIs) for CMOs within area of responsibility, monitor performance, and promptly address undesirable trends
Sponsor and direct the development of projects to improve quality assurance processes related to Bioverativ products; Partner with applicable functions (Manufacturing Operations, Regulatory Affairs, Manufacturing Sciences, Supply Chain)
Maintain an external network of expertise and represent the site and company in professional organizations
Comply with Company Safety Program, including Health and Safety regulations and OSHA requirements
Bachelor’s degree is required. Masters is preferred or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities for this position.
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 working with external partners (e.g. CMOs, packaging sites and distributors)
Demonstrate strong leadership capabilities, but also the ability to actively listen
Experience with biologics drug substance and drug product manufacturing processes, including aseptic processing; additional experience with finished goods packaging and distribution operations is ideal
Ability to influence in a matrix organization
Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach
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.
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