East Swiftwater, Pennsylvania; Swiftwater, Pennsylvania
Provide the leadership, direction, and oversight of the Biological Services Operations for B59 BSA at the Swiftwater site. This position is responsible for operational results of the Buffer and Services Manufacturing Areas within the Antigen Manufacturing Operations, including safety, quality, supply, and financial results.
Provide leadership and direction to the Buffer and Services Operations in support of Antigen Bulk Manufacturing to meet the established strategic vision of the Biological Areas in B59. This Deputy Director is responsible to ensure the manufacturing facilities and equipment within his/her control is properly maintained. In addition, this position will verify the continued validated state of all equipment and processes within their assigned area of responsibility.
Provide leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality.
Responsible for ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements.
Provide direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained.
Responsible for ensuring that all associates have what they need to complete their jobs safely.
Responsible for special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area.
Development of working relationships and strong communication links through all levels of the organization.
Provides day-to-day support for the production floor to support completion of short-term projects.
Provides leadership and establishes departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement.
Builds and maintains a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments.
Provide direction, evaluate and develop performance of direct reports
Help in resolution of problems or introduction of changes in their respective areas
Set performance standards and evaluate performance
Provide career development and training advice and set short term and long term goals
Provide regular feedback to direct reports on company and departmental operations
Manages headcount and expenses in department to achieve site objectives and meet budget expectations
Scope and dimensions
Breadth of responsibility (global/regional/country/site):
B59 Swiftwater Site
Key dimensions: headcount (direct and indirect) budget, doses, Capex… -
Headcount management : direct/indirect
Annual budget under indirect responsibility
Interact successfully within the highly energized production and regulatory environments.
Drive continuous improvement for production, Industrial Performance, and Compliance
The incumbent must be able to communicate clearly the cGMP requirements
Freedom to act, level of autonomy :
Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements.
Basic Qualifications: (Education and experience)
Minimum Bachelor's degree in Life Sciences, Engineering or Business Management
Minimum 10-15 years' experience in a cGMP controlled / pharmaceutical industry, with at least 7 years' experience in a management related role
At least 5 years' experience a regulated Quality environment
Thorough knowledge of cGMPs and regulatory requirements
MBA or Master's degree is preferred.
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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