- Oversees all GxP activities related to clinical packaging and labeling, comparator supply, and distribution.
- Applies current Good Manufacturing Practice principles in all areas of responsibility.
- Develops and maintains packaging room schedules to identify timelines as to when jobs will be executed and assign appropriate personnel to each room.
- Oversees material specification and acquisition processes, label production and approval, and randomization approval process.
- Coordinates activities between internal departments, clients, and suppliers.
- Develops specific short-term and long-range goals and programs as well as supporting budget requests and financial estimates.
- Manage all activities and all projects in conjunction with local change control procedures.
- Responsible for assuring that GMP and SOP guidelines are followed.
- Drives quality and productivity to meet client delivery requirements and financial commitments.
- Participates in daily reviews and Gemba walks to accurately report and communicate actions to attending departments.
- Assists with escalated issues and resolves any issues in conjunction with QA and Team Leaders.
- Works with Project Management to resolve any questions associated with manufacturing and packaging operations.
- Provides Feedback to Senior Management with any issues and concerns, and provides monthly reports on quality, safety, on-time performance, and productivity of the group.
- Develops staffing resource plans to ensure that client and business needs are met.
- Certifications for lean management, packaging, quality, supply chain, management, or pharmaceuticals helpful
- Experience in process validation or process engineering
- Bachelor of Science and 10+ years of related experience in food, chemical, cosmetics, or pharmaceutical packaging.
- More than 5 years of experience in clinical trials supply or 5 years of experience in an FDA or EU GMP-regulated environment
- Prior experience working within a clinical supply operations role, ideally for a small-to[1]midsized CDMO / Contract Packaging Organization (CPO).
- Experience leading a clinical trial packaging and labeling operation, working with multiple stakeholders across QA, Logistics, Supply Chain, and Project Management.
- Strong understanding of GxP regulations
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Director of Clinical Supply Operations - Charlotte, United States - Top Quality Recruitment
Description
Employment Type: Full-timeAvailable Positions: 1
Location: On-Site
Application Deadline: May 9th, 2024
Summary
The Director of Clinical Supply Operations will be responsible for the day-to-day operational management of the GMP labeling and packaging operations. This will include but not be limited to, ensuring compliance with all regulatory processes and procedures associated with secondary GMP operations, receiving, storing, label production, packaging, distributing, returns processing, and project management
Key Activities
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attach your resume to your application.
Job ID: 7218
Director of Clinical Supply Operations professionals in Charlotte
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Evan Biittig
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Barry Rewis
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