Deputy Director – Influenza Upstream Manufacturing - Vaccine (B79)-Swiftwater, PA
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The Deputy Director, Manufacturing - Vaccine will provide the leadership, direction, and the overall oversight of the B79 Flu upstream processing manufacturing operations at the Swiftwater, PA site. This position is responsible for business results of B79 Flu operations, including safety, quality, supply, and financial results.
This position is responsible for an operation that runs 7 days per week, and 24 hours per day.
In addition, this position is responsible for but not limited to the following:
Providing leadership and direction to the Viral Upstream Manufacturing to meet the established strategic vision of the areas in B79. Ensuring the manufacturing facilities and equipment within his/her control is properly maintained as well as verifying the continued validated state of all equipment and processes within their assigned area of responsibility.
Providing leadership and direction to ensure Deviations, Change Controls, CAPAs, and regulatory commitments are met on time and with the highest standards of quality. Ensuring assigned areas meet current FDA, International Regulatory Body, and Corporate Quality requirements.
Providing direction and oversight for the shop floor and is accountable to ensure the highest safety and quality standards are maintained. Ensuring that all associates have what they need to complete their jobs safely.
Special projects including providing assistance and recommendations regarding buildings, equipment, and processes relating to the integration of the manufacturing area. The development of working relationships and strong communication links through all levels of the organization. Providing day-to- day support for the production floor to support completion of short-term projects.
Providing leadership and establishing departmental objectives to align with site vision for safety, quality, productivity, cost, continuous improvement, and employee involvement.
Building and maintaining 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.
Providing direction, evaluate and develop performance of direct reports.
Helping in resolution of problems or introduction of changes in their respective areas.
Setting performance standards and evaluate performance.
Providing career development and training advice and set short-term and long-term goals.
Providing regular feedback to direct reports on company and departmental operations.
Managing headcount and expenses in department to achieve site objectives and meet budget expectations.
Bachelor’s Degree in Life Sciences, Engineering or Management.
A minimum of five (5) years’ experience in a regulated Quality environment.
A minimum of two (2) years’ experience with cGMPs and regulatory requirements.
A minimum of five (5) years in a management related role in a similar industry
A strong background in continuous improvement/CAPA implementation
Previous experience with biologic manufacturing and firm understanding of equipment associated with their manufacture
Involvement with Regulatory Agency inspections including shop floor tours and documentation audits
Demonstrated customer focus through meeting commitments and deadlines
Demonstrated ability to build networks and relationships at various organizational levels with strong interpersonal skills
Ability to learn and understand complex processes quickly, then explain those processes with ease to various internal and external audiences with level appropriate detail
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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