- Reference: AJ46202
- Job Type: Permanent
- Location: Dublin North
- Category: Science, Pharmaceutical & Food
Manager, CMC Global Product Quality
We are currently recruiting a CMC Global Product Quality Manager who will be responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met.
Global Product Quality Manager Key Responsibilities:
- Maintains the primary quality lead with management oversight for project Quality activities and the team members to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality, risk management, and compliance aspects of product transfers and organization optimization.
- Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced as well as third party manufacturing (TPM) facilities.
- Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high-risk events to management.
- Establishes and maintains relationships and open communication with Third Party Manufacturers, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
- Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide the company with the agreed service.
- Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.
- Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers.
- Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups (R&D, S&T, Site Tech Ops) to determine root cause and implement appropriate actions.
- Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget.
- Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
- Supports the regulatory filings and marketing authorisation dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents.
Education & Experience:
- Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.
- 8+ years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development, Regulatory or Consulting. Direct Plant experience in a Pharmaceutical setting is beneficial.
- Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
- Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
- Experience with FDA and other regulatory agency interactions and inspections.
- Familiarity with the requirements for third party external manufacturing.
Travel: 25 %
For more information or to apply please contact Tina Egan on email@example.com 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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