Title: QC Raw Materials and Compendial Associate Director
Location: Dundalk
Industry: Biologics
Description:
As QC Raw Materials and Compendial Associate Director you will be responsible for ensuring the highest standards of professional regulatory adherence excellence and quality within the business, with overall responsibility for the management of QC instruments/equipment and analytical test methods for raw materials testing, managing raw materials specifications and raw materials release, sampling of raw materials for QC testing and managing raw materials regulatory retain samples, leading product compendial testing, and other project support functions. Working closely with senior 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.
Department Description
As QC Raw Materials and Compendial Associate Director you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QC Director.
Responsibilities
1. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
2. Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.
3. 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.
4. From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
5. Develop/build a world-class Biologics QC Raw Materials and Compendial testing team, including planning, recruiting/hiring, coaching/mentoring, and training for approximately 8-15 total headcount.
6. Responsible for raw materials and compendial routine testing, method verification, and method transfer.
7. Management of raw materials and compendial testing QC instruments and equipment
8. Raw materials sample management, including sampling, sample log-in and disposition, as well as routine inventory checks of regulatory retention samples.
9. Author technical documents, including relevant SOPs, testing protocols and reports, raw materials specifications, and raw materials expiries.
10. Represent Raw Materials and Compendial testing teams in regulatory inspections and client and internal audits.
11. Serve as a technical lead in applicable investigations, deviations, change controls, and CAPAs.
12. Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
13. Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
Education and Experience:
14. University degree in related science/quality discipline required.
15. D. with 5+ years of experience, or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired.
16. 15+ years’ experience working within Quality Control/GMP environment with a well-rounded exposure to all areas in this field and significant experience with raw materials and compendial testing.
17. Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities.
Preferred:
18. Previous experience with regulatory inspections and internal/customer audits is strongly preferred.
19. Previous experience working in a CMO is a plus.
20. Excellent interpersonal, verbal, and written communication skills.
21. Able to think critically and demonstrate troubleshooting and problem-solving skills.
22. Self-starter and self-motivated; organized with good attention to detail.
23. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
24. Results oriented, with the ability to manage multiple priorities in a short period of time.
Interested candidates should submit an