Associate Director/Senior Manager - Global QMS, Global R&D & PV QA

The primary objective of this role is to serve as a GCP/GLP/GVP Quality Assurance Subject Matter Expert, overseeing the review and quality assurance of all GCP/GLP/GVP-related Standard Operating Procedures (SOPs) to ensure they are comprehensive, compliant with international GCP/GLP/GVP standards, and harmonized across global practices.

This includes serving as the main liaison for GCP/GLP/GVP regulatory inspections and audits, assisting with preparation and strategy, and ensuring consistent documentation and effective follow-up actions and collaborating with Functional QA within Global R&D & PV QA to enhance the Quality Management System (QMS)through the evaluation of quality metrics and audit findings, while also developing and delivering training programs on ICH and regulatory requirements.

JOB DESCRIPTION

1. GCP/GLP/GVP SOP Oversight & Regulatory Compliance

- Serve as GCP/GLP/GVP QA Subject Matter Expert responsible for review and quality assurance of all GCP/GLP/GVP-related SOPs.

- Ensure SOPs are comprehensive, cross-referenced, and compliant with evolving international GCP/GLP/GVP standards (ICH E6 GCP, US 21 CFR Parts 50,56, 312, 812), EU Clinical Trial Regulation (CTR) No.536/2014, Japan GCP, and China GCP, OECD Principles of Good Laboratory (GLP), EU GVP Modules I-XVI, US FDA 21 CFR 314.80, 600.80, 606.170 & PV guidance, Japanese GVP Ordinance & MHLW GVP Ministerial Ordinance, and China GVP etc.).

- Lead SOP landscape reviews to identify gaps, redundancies and misalignments drive harmonization across global SOPs.

2. Regulatory Inspection or Audit Support

- Serve as the main QMS liaison for GCP/GLP/GVP inspections (e.g. FDA, EMA, PMDA) or audits. Responsibilities include :

i. Assisting with the inspection preparation and strategy.
ii. Participating in inspections or audits to ensure consistent messaging and proper documentation.
iii. Providing QMS input for CAPA responses and follow-up actions after inspection or audit to ensure effectiveness and sustainability.

3. Quality Management System Support

- Collaborate closely with Functional QA and provide expertise in the implementation, maintenance, and continuous improvement of the QMS.

- Evaluate trends, quality metrics, and audit findings to drive continuous improvement initiatives.

4. GCP/GLP/GVP Training and Capability Building

- Partner with the Functional QA to develop, deliver, and maintain training programs and materials on :

i. GCP/GLP/GVP and other evolving regulatory requirements.
ii. Quality and GCP/GLP/GVP inspection readiness topics tailored for respective business function and Functional QA.

5. Regulatory Intelligence & Compliance Monitoring

- Work cross-functionally with Regulatory Affairs to proactively collect and assess GCP/GLP/GVP-related regulatory intelligence from key markets (e.g., US, EU, Japan, China).

- Ensure timely communication of new or evolving GCP/GLP/GVP regulations and support their integration into GCP/GLP/GVP-related SOPs, training materials and QA processes.

JOB REQUIREMENTS

- Bachelor's or Master's degree in Life Sciences, Pharmacy, Medicine or related field.

- Minimum 10 years of relevant GCP/GLP/GVP experience in the pharmaceutical or biotechnology industry, including GCP/GLP/GVP Quality Assurance or Clinical Quality Management, GCP/GLP/GVP Audit Program execution or management and regulatory inspection support.

- In-depth knowledge of ICH and relevant global GCP/GLP/GVP regulations (FDA, EMA, PMDA, NMPA, etc.) frameworks and evolving requirements.

- Experience in CAPA development and QMS implementation/improvement.

- Exposure to Clinical Development, Clinical Operation, Medical Affairs and Pharmacovigilance operations.

- Excellent written and verbal communication skills.

- Critical thinking and problem-solving mindset with strong analytical abilities.

- Ability to influence and collaborate cross-functionally across clinical, medical affairs, PV, regulatory affairs and R&D & PV QA team.

- Demonstrate ability to manage multiple priorities in a global and matrix environment.