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

DAIICHI SANKYO SINGAPORE PTE. LTD.; Singapore; On-site; SGD 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Singapore seeks a Quality Assurance Subject Matter Expert to oversee GCP/GLP/GVP compliance across SOPs and support regulatory inspections. Candidates should have at least 10 years of GCP/GLP/GVP experience in the pharmaceutical or biotechnology industry, and possess a deep understanding of ICH and global regulations. Strong collaboration and analytical skills are essential for this dynamic role focused on quality assurance and regulatory compliance.

Qualifications

• Minimum 10 years of relevant GCP/GLP/GVP experience.
• In-depth knowledge of ICH and global regulations.
• Experience in CAPA development and QMS improvement.

Responsibilities

• Serve as QA Subject Matter Expert for GCP/GLP/GVP.
• Ensure compliance with international regulatory standards.
• Collaborate with Functional QA to enhance the QMS.
• Conduct training programs on GCP/GLP/GVP standards.
• Provide support during regulatory inspections and audits.

Skills

GCP/GLP/GVP Compliance

Quality Management System (QMS)

Regulatory Inspection Preparation

Cross-functional Collaboration

Critical Thinking

Analytical Skills

Education

Bachelor's or Master’s degree in Life Sciences

Job description

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. 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. 2. Regulatory Inspection or Audit Support
   • Assisting with the inspection preparation and strategy.
   • Participating in inspections or audits to ensure consistent messaging and proper documentation.
   • Providing QMS input for CAPA responses and follow-up actions after inspection or audit to ensure effectiveness and sustainability.
3. 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. 4. GCP/GLP/GVP Training and Capability Building
   • GCP/GLP/GVP and other evolving regulatory requirements.
   • Quality and GCP/GLP/GVP inspection readiness topics tailored for respective business function and Functional QA.
5. 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>