The Senior Manager of Quality Assurance role offers the opportunity to play a critical leadership role in ensuring robust quality management systems and maintaining compliance with regulatory requirements within a pharmaceutical environment. This position is ideal for an experienced quality professional who enjoys working across global and local stakeholders, supporting product quality, supply chain operations, and regulatory obligations while contributing to patient-focused healthcare solutions.
Responsibilities
Implement and maintain the product Quality Management System (QMS) for GMP/GDP, including related Standard Operating Procedures (SOPs), to fulfil local MAH responsibilities.
Act as the official Qualified Person Delegate and ensure proper product release to the market.
Establish and maintain Quality Technical Agreements (QTAs), quality agreements with contract warehouses, and service contracts with external providers.
Provide quality support for Supply Chain Management (SCM) activities, including collaboration on cold chain products.
Communicate and collaborate with global quality teams, external suppliers, regulatory stakeholders, and cross-functional departments on quality-related matters.
Provide relevant quality departments with information regarding GMP/GDP inspections conducted by authorities.
Plan and conduct self-inspections and support continuous quality improvement initiatives.
Manage training programmes, documentation and record control processes.
Lead change control activities and oversee Annual Product Quality Report Reviews (APQR).
Handle complaints and recalls in cooperation with relevant quality departments.
Maintain approved dossiers in collaboration with Regulatory Affairs CMC.
Participate in cross-functional projects involving R&D, Manufacturing, Supply, Distribution, Quality, and Regulatory functions.
Contribute to additional quality control and compliance-related activities as required.
Requirements
Experience
Minimum 15 years of experience within the pharmaceutical industry, including Quality, Compliance, and/or Regulatory functions.
Previous experience liaising with Japanese regulatory authorities, including PMDA, Tokyo Metropolitan Government, and/or MHLW.
Experience in CMO oversight, risk management, and project management.
Previous experience leading teams and/or managing people.
Knowledge and Skills
Strong verbal and written English communication skills.
Excellent communication and presentation abilities in both Japanese and English.
Ability to foster strong cross-functional collaboration and shared accountability across local and global teams.
Knowledge of GMP compliance inspections in Japan.
Knowledge of Japanese Pharmacopoeia (JP), EU GMP, and ICH guidelines.
Broad understanding of Supply Chain Management activities, particularly for cold chain products.
Technical knowledge of Biologics CMC, GQP, GMP, and pharmaceutical laws and regulations.
Strong analytical, problem-solving, and prioritisation skills.
Ability to manage multiple tasks and stakeholders effectively.
Benefits
Hybrid working arrangement.
Comprehensive insurance coverage.
About the Company
A company in the pharmaceutical industry, this global organisation develops and provides treatments focused on psychiatric and neurological disorders. With a long-standing commitment to healthcare innovation, the company works across international markets to deliver therapies that support patients worldwide.