Associate Director of Audit & Inspection

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POST DATE 9/17/2017
END DATE 11/5/2018

AstraZeneca Pharmaceuticals LP Gaithersburg, MD

Gaithersburg, MD
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


b Location: /b Gaithersburg, br Maryland, br United States br b Job reference: /b R-014088 br br b Posted date: /b Sep. 14, 2017 p 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 b Associate Director, Audit and Inspection /b in b Gaithersburg, MD /b , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. b GMD /b (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. /p p 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. /p p As an b Associate Director of Audits & Inspection /b 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. /p p 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! /p p b Main Duties and Responsibilities /b /p ul li 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. /li li Participate in and may lead directed (For Cause) audits. /li li Works with contract personnel or consultants to prepare, conduct and report outsourced audits /li li Assesses need for, and assists in facilitating development of, and approves CAPA plans /li li Maintains and updates the audit management system in a timely manner /li li Works with QA lead to manage regulatory inspections as assigned including provided training to the organisation as needed. /li li Involved and may lead the development and/or revision of QA processes and procedures including SOPs and risk assessment tools /li li Travel up to 25% expected /li li Ensures own tasks are performed to current practices and in accordance with company standards and policies /li li Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena /li /ul