We have a new opening for a QC Associate Director for our Pharmaceutical Manufacturing client based in Dundalk. You will be a key member of the QC leadership team. The QC Associate Director of Bioassays and Biochemical Assays will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business. The position will involve management of product testing teams, including bioassays and biochemical assays. You will work closely with senor leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.
Overview of your responsibilities (full job description available on request):
- You will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
- Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.
- The role will require extensive liaison with counterparts and business leaders to include the highest level of professional representation of the local site QC organisation.
- From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
- Develop/build a world-class Biologics QC bioassays and biochemical assays product-testing team, including
- planning, recruiting/hiring, coaching/mentoring, and training for 15-20 total headcount
- Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
- Interact with internal and external partners, clients, and inspectors and maintains high quality standards and Services
- Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations
- Serve as a technical lead supporting applicable non-conformances, atypical/OOS investigations, change controls deviations, and CAPAs
- Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizingthe
- workflow and maximizing the operation efficient while maintaining full compliance
- Provide effective communication and play a leading role in project management interaction with
- internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical
Knowledge, Skills, and Experience Required for the Role:
- University degree in related science/quality discipline required.
- Ph.D. with 5-8 years of experience, or Masters would be an advantage but not essential.
- More than 15 years working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
- Ideally, experienced in establishing a QC function and building a team in a ‘greenfield’ context of similar size and scale.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.
- Management/supervision of personnel with particular attention to schedules and shifting priorities is required and demonstrated leadership skills
- Previous experience in a Quality Control/GMP environment is required
- Previous experience with regulatory inspections and internal/customer audits is strongly preferred
- Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines
For a confidential discussion and more information on the role contact Gillian Nicholsongillian.firstname.lastname@example.org
+353 01 6620088