QC Raw Materials and Compendial Associate Director
This role will play an integral part in the development of the local QC strategy/business planning, aligned closely with the global QC function.
Key Responsibilities:
* Strategic leadership and business planning processes to ensure cross-functional collaboration and execution.
* Closely work with senior leaders to achieve business targets and objectives.
* Liaise with counterparts and business leaders for professional representation of the local site QC organisation.
* Support the design, construction, and commissioning of the new facility for the production of drug substance.
* Develop a world-class Biologics QC Raw Materials and Compendial testing team.
* Manage raw materials and compendial routine testing, method verification, and method transfer.
* Manage raw materials and compendial testing QC instruments and equipment.
* 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 and internal audits.
* Serve as a technical lead in applicable 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.
Requirements:
* University degree in related science/quality discipline required.
* 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.
* 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.
* Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project Management/supervision of personnel with particular attention to schedules and shifting priorities.
PREFERRED SKILLS:
* 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.
* Self-starter and self-motivated; organized 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.