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Lieu: Gaithersburg, Maryland, États-Unis
ID de l'offre 11249265
Date de publication: 04/01/2019

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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, in Gaithersburg, MD (Washington DC Metro Area), 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.

Job Description

Plans, leads and conducts execution of audit activities for Science Unit risk based audit program. Conducts audits in all or some areas of GCP, GVP, GRP or LabGCP. Reports audits and findings and escalates when appropriate. Responsible for evaluation of risk, standards and quality principles. Manage and facilitate regulatory inspections.

The jobholder reports to the Director Quality Assurance in Audit team.

Job Responsibilities / Accountabilities

  • 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 expected
  • Ensures own tasks are performed to current practices and in accordance with company standards and policies
  • This is not a remote position and is based in Gaithersburg, MD.

Typical Accountabilities

  • Drives and embeds a culture of ethics and integrity
  • Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena
  • Maintains knowledge and compliance to relevant regulation, policies, standards, SOPs and guidelines
  • Promotes a culture of continuous improvement that focuses on delivering efficiencies and planned business benefits

Education, Qualifications, Skills and Experience

Essential

  • Degree in a scientific discipline or qualified professional in compliance, law, regulations related to area of accountability
  • Experience in pharmaceuticals or a related industry
  • Excellent analytical, written and oral communications skills (English)
  • Strong ability to work independently
  • Strong collaborative, partnering, and interpersonal skills
  • High ethical standards, trustworthy, operating with absolute discretion
  • Performing level of the following capabilities in the QA capability framework;
    • Influencing & Negotiating skills
    • Knowledge of Design and Conduct of Audits (and Due Diligence) & Inspections
    • Regulatory Environment Insight:
    • Active Management of Risks & Opportunities
    • Business Relationship Management
    • Conceptual thinking

Desirable

  • Experience supporting regulatory authority inspections
  • Project management skills

Next Steps – Apply today!

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 lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Associate Director, Quality Assurance - GCP
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