A fantastic opportunity has arisen in a leading Pharmaceutical Company in Dublin to join a growing Global Quality team. This is a challenging and a dynamic role that will highly suit a driven and ambitious individual.
We are currently recruiting a 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 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 AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands.
- 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 at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
- 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. 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.
- Establishes and maintains relationships and open communication with Third Party Manufacturers, company plants, 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. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Acts as a resource for TPMs to evaluate and interpret industry regulations, assess risk, and develop an implementation strategy as the regulations relate to Operations domestically and internationally.
- 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 your company with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
- 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. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third-party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
- Manages Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to your company's domestic and International plants for further packaging and/or testing. Drives implementation of the Product Transfer Process from R&D to company sites.
- 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. 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.
- 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. Work with company Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions.
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.
- 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.
If you're interested, apply now to be considered. If you are unsure if this is something that is right for you or want to see what other opportunities are available, feel free to get in touch on 014744692 or alternatively email me at firstname.lastname@example.org