At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As an Associate Director, Audit and Inspection
in Gaithersburg, MD
, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD
(Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
The QA department is part of the R&D organisation which drives development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them. This role, in particular, will work across early to late stage development across all Science Units (R&D) within the company.
As an Associate Director of Audits & Inspection
you will get the opportunity to lead execution of clinical and pharmacovigilance quality assurance audits for Science Unit risk based audit program. You will be responsible for evaluation of risk, standards and quality principles. You will also manage and facilitate regulatory inspections.
If you have a sound understanding of Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GPvP) guidelines and regulations, along with experience in carrying out and leading audits, this is a unique opportunity for you to join us!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
- Travel up to 25% expected
- Ensures own tasks are performed to current practices and in accordance with company standards and policies
- 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
Next Steps - Apply today!
- Experience supporting regulatory authority inspections
- Project Management Skills
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.