Our client is a global pharmaceutical company.
We are seeking a strategic QA lead for APAC to join a collaborative team dedicated to excellence. In this role, you will bridge the gap between business strategy and quality execution. Your goal is to embed a risk-based quality culture into Medical Affairs, ensuring patient safety and data integrity.
Key Responsibilities
- Drive the end-to-end quality strategy for Medical Affairs, ensuring regional activities align with global compliance standards
- Proactively identify and mitigate risks across interventional and non-interventional trials, investigator-initiated studies, and managed access programs.
- Act as the primary QA advisor to business leaders, fostering a solution-oriented culture and collaborating with vendors to maintain high data quality.
- Lead inspection readiness initiatives and manage direct interactions with regional and global Health Authorities (eg FDA, MHRA, PMDA, etc.).
- Oversee the CAPA process and monitor Key Quality Indicators to drive organizational learning and operational excellence.
Requirements
- 8+ years in Clinical Development, Medical Affairs, or QA, with a strong track record in the pharmaceutical industry
- Experienced managing regulated activities (clinical development, Medical Affairs, Pharmacovigilance and/or Quality Assurance
- You possess a deep understanding of post-marketing studies and have successfully navigated interactions with major Health Authorities.
- You thrive in global, cross-functional environments and can influence stakeholders at all levels.
- You combine technical expertise in product development with the ability to lead high-impact projects independently.
