Director of Audit and Inspection for Quality Assurance (GCP/GPvP) - Gaithersburg, MD | Biospace
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Director of Audit and Inspection for Quality Assurance (GCP/GPvP)

AstraZeneca Pharmaceuticals LP

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                                       Location:Gaithersburg, Maryland, United States
Job reference: R-001515

Posted date: Dec. 20, 2016



   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 a Director of Audit and Inspection for Quality Assurance (mainly in GCP/GPvP) in Gaithersburg, MD, you’ll play a pivotal role in channelling 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. This role, in particular, will work across early to late stage development.  

   Main Duties and Responsibilities  


   In this position, you will be tasked to lead some of the most complex, clinical and pharmacovigilance quality assurance (QA) audits that AstraZeneca conducts. Every day will be new and a passion for this type of environment, where you will be challenged to be solution driven and adaptable, is critical. This role will entail acting as the senior point of contact for regulatory authorities and providing lead support in regulatory inspections of AstraZeneca’s development activities. You will work with a global team to conduct QA audits, facilitate and lead regulatory inspections, and communicate the results with colleagues and customers.


   Essential Requirements  

  •      Qualified Professional with a quality assurance or regulatory compliance background    
  • Bachelors Degree (life sciences or chemistry disciplines preferred)
  •      Significant experience in pharmaceuticals or biopharmaceuticals industry    
  •      In-depth knowledge of Good Clinical Practice or Good Pharmacovigilance Practice health care regulations, laws and standards    
  •      Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective and preventive action plans which mitigate risks to data integrity and safety.    
  •      Excellent analytical, written and oral communication skills    
  •      Good influencing skills-can influence without authority    
  •      Strong collaborative, partnering and interpersonal skills    
  •      Strong ability to work independently    
  •      High ethical standards, trustworthy, operating with absolute discretion    
  •      Fluent in written and spoken English    
  •      Ability to travel.    

   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 law.