Essential Duties and Responsibilities :
- Manage day to day technical operations matters. This includes investigations, deviation management, CAPAs, Veeva Maintenance, CMO Management etc.
- Operations team member with responsibility to solve for technical or operational issues.
- Oversee the maintenance of technical operations for all suppliers. Manage change initiatives at suppliers in coordination with Regulatory and Quality Assurance.
- Develop strategies for all products to meet supply needs and help resolve quality issues.
- Oversee the management of interactions and set and maintain high standards and expectations of contractors and vendors who support supply operations.
- Provide input on Quality Assurance and Regulatory matters as needed.
Qualifications :
- Knowledge of pharmaceutical sterile fill manufacturing. The candidate will preferably have experience working at a sterile fill manufacturing plant.
- Familiarization with Active Pharmaceutical Ingredient (API) Manufacturing.
- Familiarization with pharmaceutical tablet manufacturing.
- Experience with managing investigations, change controls, CAPAs, deviations, etc.
- Experience working with or managing Contract Manufacturing Organizations (CMOs).
- Experience managing documentation within VEEVA or similar quality systems.
- Experience with supporting regulatory filings and participating in regulatory inspections.
- Excellent leadership, organizational skills, strong oral and written communication skills, and will be able to work in a high paced, timeline driven corporate office setting
- Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
- Maintains a positive and professional demeanor toward all customers and coworkers.
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