- Reference: 46236
- Job Type: Permanent
- Location: Dublin North, Leinster, Meath
- Category: Science, Pharmaceutical & Food
CMC Global Product Quality Leader
We are currently sourcing a CMC Global Product Quality Leader 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 with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by internal plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. This role will be based in Ireland (Santry, Dublin).
Maintains the primary product quality lead with oversight for project activities and the team members (within and outside of the company) to achieve on-time quality deliverables, high customer value, and profitable results. Primary product quality implementer of quality and compliance aspects of product transfers and organization optimization.
Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at the company plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
Makes recommendations with oversight for 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 company management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
Maintains relationships and open communication with Third Party Manufacturers, internal plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an understanding of the quality, compliance, and resource needs at each site and provide input on quality concerns.
Liaises with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to internal domestic and International plants for further packaging and/or testing. Supports the management of exception documents and Corrective and Preventive Actions. Initiates Change Plans, performs follow-up, and timely closure of the change plans. Collects product quality transfer process monitoring metrics.
Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third-Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
Responsible for material specification documents that need to be established at internal sites. These include intermediate specifications, API specifications, Drug product specifications, raw material specifications, and excipient specifications. Additional responsibilities include obtaining vendor support documentation in preparation of Gluten risk assessments, melamine risk assessments, elemental impurities, and micro assessments.
Education & Experience:
- Bachelor’s Degree in relevant Life Science or other technical discipline or equivalent job experience required.
- 7+ years of total combined experience. At least 3 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development 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).
- Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
Primary Location: Ireland-Leinster-Dublin
Travel: Yes, 25 % of the Time
For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie