Tasks

  • Act as quality assurance representative for GMP/GDP-relevant topics across development and commercialization phases of drug products
  • Coordinate and monitor quality-related activities in alignment with the respective development stage of each project
  • Ensure pharmaceutical products are developed, manufactured, and tested in compliance with applicable quality and regulatory standards
  • Provide QA input in handling deviations, OOS results, complaints, investigations, and test anomalies; propose and follow up on appropriate CAPAs
  • Support implementation of quality risk management strategies using six sigma principles and contribute to training of cross-functional teams to promote quality awareness across the product lifecycle
  • Oversee release activities for drug substances and drug products, including review and approval of batch records, master documentation, and change control assessments
  • Escalate identified quality or regulatory risks that could impact project timelines to the CMC team and relevant stakeholders
  • Represent QA in cross-functional CMC project meetings and contribute to decision-making processes from a quality standpoint
  • Draft and manage GMP/GDP agreements in close collaboration with external manufacturing partners and internal CMC functions
  • Review, author, and approve SOPs and other controlled GMP/GDP documents in line with internal quality standards
  • Evaluate performance data from contract manufacturers to support the continuous improvement of the pharmaceutical quality system
  • Responsible for QA release of drug substance and drug product bulk in accordance with internal procedures and regulatory requirements

Qualifications

  • Degree in Pharmacy, Chemistry, or a related technical/scientific discipline
  • At least 5 years of professional experience across areas such as pharmaceutical development, quality control, analytical development, or chemical manufacturing within the pharmaceutical industry
  • Several years of hands-on experience in quality assurance for drug substances and/or drug products
  • Strong understanding of pharmaceutical development processes, manufacturing, quality control, packaging, and distribution
  • Solid working knowledge of current GMP and GDP regulations and their practical application
  • Capable of interpreting and applying quality standards within complex operational frameworks
  • Proven ability to manage complex projects and balance competing priorities based on project needs
  • Self-driven approach to initiating, leading, and implementing quality-related activities
  • Comfortable handling multiple tasks in a dynamic and fast-paced environment
  • Excellent interpersonal and communication skills, with the ability to influence and collaborate across various functions
  • Confident and assertive in navigating complex stakeholder interactions and decision-making processes
  • Fluent in English, both written and spoken