Job Details
The Senior Manager of Operations and Production Maintenance provides strong and direct hands-on leadership to Operations and Production Maintenance staff to focus on Customer Satisfaction and Operational Efficiency using thoughtful planning execution, effective communications, dynamic and responsive organization, and accurate execution of commitments. In order to support our opportunities for market growth, the Senior Manager of Operations and Production Maintenance establishes systems to ensure service level issues are prevented and/or resolved on a timely basis while also improving throughput capacity to meet rising customer demand. Critical to success in the role is the ability to meet customer expectations while managing and improving line efficiencies, lead time, reducing waste, reducing "bottlenecks", improving material utilization, improving internal project due dates to assure the meeting of customer due dates. This key impact role will serve as strategic and tactical business partner within the organization and change agent by directing planning and execution methods while maintaining and optimizing the efficiency, quality and safety of the production process.
EDUCATION & EXPERIENCE:
- Degree in Chemistry, Biology, Pharmacy, Engineering or related field required; Masters preferred
- 15-year experience in FDA or other regulatory agency environment.
- minimum of 10 years in a leadership/management position in Operations
- minimum of 3 years in a Supply Chain management role
- be knowledgeable in regulatory and technical requirements of the pharmaceutical industry, have interacted directly with regulatory agencies, and have a strong management background.
- in audits and regulatory inspection including PAI.
- in aseptic manufacturing, filling, and packaging, facility operation, and quality systems.
KNOWLEDGE SKILLS & ABILITIES:
- of aseptic manufacturing and filling
- of manufacturing and packaging in a pharmaceutical operation
- of production planning and S&OP process
- of Lean and Operational Excellence applications in the pharma industry
- of cGMP and FDA and International regulations