Sr. Packaging Manager
Sr. Packaging Manager
The Senior Manager is the leader for packaging operation and is responsible for producing high quality products in accordance with regulatory requirements to achieve the operating strategy. This individual will train and develop personnel, develop and maintain packaging schedules, and manage the department budget. The Senior Manager must maintain effective employee relations, compliance to cGMP and other regulatory and SOX requirements, as well as Environmental and Safety obligations, and company policies.
- Provide direction to packaging personnel in the efficient use of equipment and materials to produce quality products in accordance with the production plan
- Responsible to maintain strategic alignment with Site Leadership Team direction, goals, & objectives.
- Promote the use of safe work practices during all aspects of production and ensure all external and company policies and EHS standards are met on a daily basis.
- Accountable for training personnel on equipment, processes and Standard Operating Procedures.
- Ensure that cGMP’s are used and followed during production of products so that all FDA and international regulations are upheld. Responds to internal audit observations.
- Author, review, and approve Standard Operating Procedures and other documents to ensure integration of cGMPs and improve process efficiencies.
- Collaborate with supporting departments to optimize process performance.
- Participate in the design, selection, installation and qualification of new equipment, facilities, and processes.
- Review, approve, and implement change control.
- Co-own life cycle management of assets and work with engineering on strategic packaging projects.
- Work collaboratively to ensure flow of product, sharing of best practices, and lean behaviors.
- Investigating and resolving problems, identifying and implementing process improvements.
- Minimum 5 years of experience in cGMP or regulated production environment
- 5 years of progressive packaging experience
- 9 years of prior supervisory or management experience
- Knowledge of FDA cGMP’s
- Strong communication and leadership skills
- Proven problem solving skills
- 5-10 years of work experience in pilot or commercial manufacturing under cGMP
- Experience working in a Lean Manufacturing Environment
- Working knowledge of Microsoft applications, SAP, Trackwise
- Training or experience in packaging, validation, technology transfer, change control.
- Knowledge or previous experience in managing technical programs/projects
- Strong troubleshooting and problem solving abilities
- Ability to direct and participate in cross-functional teams
- Project management skills
Bachelor of Science in Engineering, Pharmaceutical, related Life Science or Business