Associate Director, Quality Assurance AsiaPac
Main Duties and Responsibilities
- Plans, leads, conducts and reports audits in all or some of the GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits.
- Participate in and may lead directed (For Cause) audits.
- Works with contract personnel or consultants to prepare, conduct and report outsourced audits
- Assesses need for, and assists in facilitating development of, and approves CAPA plans
- Maintains and updates the audit management system in a timely manner
- Works with QA lead to manage regulatory inspections as assigned including provided training to the organisation as needed.
- Involved and may lead the development and/or revision of QA processes and procedures including SOPs and risk assessment tools
- Supports Project Teams, Therapeutic Area, Functional Area and other Stakeholders (as applicable) by providing strategic advice and quality planning activities (also known as ‘quality by design’), as required.
- Responds in a timely manner to requests for quality and GXP compliance advice and offers proactive advice to defined customer groups.
- Contributes towards QA the management of Quality Issues
- Travel up to 25% expected
- Ensures own tasks are performed to current practices and in accordance with company standards and policies
- Act as trainer and mentor for GCP and/or GPvP Auditors
- Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena
- Degree in a scientific discipline or qualified professional in compliance, law, regulations related to area of accountability
- Established GCP / GPvP QA professional
- Knowledge of Design and Conduct of Audits and Inspections
- Active Management of Risks & Opportunities
- Experience in pharmaceuticals or a related industry
- In depth knowledge of relevant regulations in the relevant GXP areas, quality standards (e.g. ISO) and guidance and the latest regulatory authority and industry interpretation. Awareness of draft regulations and guidance in other GXP areas and the potential impact on AstraZeneca
- Excellent analytical, written and oral communications skills (English)
- In depth understanding of the interactions between GXPs in the drug development process and the applicable regulations
- Strong collaborative, partnering, and interpersonal skills
- Strong ability to work independently
- High ethical standards, trustworthy, operating with absolute discretion
- Influencing & Negotiating skills
- Conceptual Thinking
- Experience supporting regulatory authority inspections
- Project Management Skills
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.