Director/Associate Director (RM)

Responsibilities

1. Manage all operational aspects of the Quality Control RM functions in support of incoming materials testing/release for drug substance and drug product in all site's projects.

2. Oversee incoming materials/RM related testing and method qualification, including Identification, LOD, appearance, moisture, Bioburden and endotoxin testing of raw material and other required incoming materials. Perform technical review of USP/EP/JP/CHP to ensure methodology and procedures are compliant with the current standards. Ensure in-house operations are complying towards latest GMP and regulatory authorities requirements.

3. Oversee the set-up of RM sampling, testing/reduced testing and releasing strategy. Perform or participate in quality risk assessment when necessary.

4. Oversee the investigation of quality problems in RM/incoming materials release and propose appropriate CAPAs to resolve deviations/excursions and to prevent recurrence.

5. Manage deviation, change control and CAPA, participate in client or regulatory audit inspections.

6. Initiate, lead, support and oversee continuous improvement initiatives for QC RM team. This includes on-going company's initiatives such as the integration of WBS (Wuxi Business System) into routine operations.

7. Responsible for developing Quality Control RM teams training program. Ensure all staff receive necessary training in cGMP training in RM and SOPs. Ensure staff are following company IP, data integrity, GMP, GDP and EHS requirements.

8. Responsible for staff annual performance appraisal and managing performances of direct QC reports.

9. Responsible for talent recruiting, development and fostering a continuous learning and improvement environment.

10. Promote and participate in collaborative work among cross-sites RM groups such as COE meeting, optimization/harmonization of RM strategies, procedures and other method optimization initiatives.

11. Responsible for global harmonization towards RM SPEC establishment and issue RM COA during release.

12. Participate in site's cross departmental meetings and ad hoc meetings to initiate or align decisions or strategies when necessary.

• 13. Other tasks assigned by QC head

Qualifications

1. Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.

2. 12+ years of relevant experience or equivalent for Bachelors

3. 8+ years for Master's in the Quality Control or related field or equivalent experience.

4. 4+ years of Management experience required.

Other requirements (e.g.: working time, special skills)

1. Knowledge of pharmacopoeia for Incoming materials/Raw material (RM) specification generation and demonstrated capability in using that knowledge to provide QC leadership to all aspect Raw material handling and management.

2. Subject matter expertise (SME) and hands-on proficiency with all aspects of pharmaceutical RM control.

3. Experience and understanding Incoming materials regulations and guidelines with in-depth understanding of cGMP.

4. In-depth experience in validating and executing RM testing methods, identification methods, and evaluating new technology or methods.

5. Experience with application of root cause analysis tools for investigation execution.

6. Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs).

7. Able to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.

8. Self-motivated and organized.

9. Excellent communication skills (both verbal and written) and interpersonal skills are required.