Title: QC Raw Materials and Compendial Associate Director
Location: Dundalk, Industry: Biologics
Description:
As the 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. This involves 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. Additionally, you will lead product compendial testing and other project support functions.
You will work closely with senior leaders in all areas of the business to develop the local QC strategy/business planning, aligned closely with the global QC function.
Responsibilities:
* 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 practices and targets are achieved in line with the business targets and objectives.
* Liaise extensively with counterparts and business leaders to represent the local site QC organization at the highest level.
* Support the design, construction, and commissioning of a new facility for the production of drug substance from a QC functional capacity.
* Develop 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.
* Manage raw materials and compendial routine testing, method verification, and method transfer.
* Oversee the management of raw materials and compendial testing QC instruments and equipment.
* Manage raw materials sample management, including sampling, sample log-in and disposition, as well as routine inventory checks of regulatory retention samples.
* Author technical documents, including relevant SOPs, testing protocols and reports, raw materials specifications, and raw materials expiries.
* Represent Raw Materials and Compendial testing teams in regulatory inspections and client/internal audits.
* Lead investigations, deviations, change controls, and CAPAs.
* Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
* Ensure tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
Education and Experience:
* University degree in a related science/quality discipline is required.
* A Master's degree with 5+ years of experience or a Doctoral degree with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field is desired.
* 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 is preferred.
* Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities is necessary.
Preferred Qualifications:
* Previous experience with regulatory inspections and internal/customer audits is strongly preferred.
* Previous experience working in a CMO is a plus.
* Excellent interpersonal, verbal, and written communication skills.
* Able to think critically and demonstrate troubleshooting and problem-solving skills.
* A self-starter and self-motivated individual with good attention to detail.
* Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
* Results-oriented, with the ability to manage multiple priorities in a short period of time.