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Location:
San Francisco, California, United States
South San Francisco, California, United States
Job reference: R-033802
Posted date: Mar. 13, 2019
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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 GLP & Research QA, in San Francisco, CA, 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

Reporting directly to member of the QA leadership team.  Leads or supervises execution of assurance activities for Science Unit quality and compliance program. Provides expert advice on relevant GLP quality and compliance, as well as lab GCP, HBS and GLS as required. Responsible for expert evaluation of risk, standards and quality principles associated with regulations and standards governing pre-clinical and bio-analytical research. Advises management and gives general assistance in relation to compliance program / risk questions/issues. May manage administrative or contracted staff.

Typical Accountabilities

  • Implements and maintains effective compliance program activities for GLP research as well as assurance of lab GCP, HBS and GLS, as required
  • Operationally executes “second line of defense” responsibilities (quality assurance assessments, auditing, investigations, assurance reporting, etc.) as a lead
  • Provides responsive and proactive quality and compliance advice to defined customers and effectively influence assigned area by being relevant GLP expert, as well as lab GCP, HBS (Human Biological Samples) and GLS (Global Laboratory Standard) as required; drives a culture that seeks to prevent non-compliance and poor quality
  • Assess need for/lead in facilitating the development of and monitoring of applicable CAPA plans
  • Support  quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
  • Support driving and embedding a culture of ethics and integrity
  • Supports operational implementation of compliance objectives (aligned with Global Compliance strategy and objectives)
  • Performs key leadership support roles for regulatory inspections as assigned
  • Works with contract personnel or consultants to prepare, conduct and report assurance audits
  • Execute assurance and advisory activities for assigned GLP area, as well as lab GCP, HBS and GLS as required and computer systems validation.
  • Communicates effectively with compliance colleagues and customers and maintains robust knowledge of relevant industry information affecting compliance arena
  • Leads training for compliance colleagues and customers as required.
  • Travel expected

Education, Qualifications, Skills and Experience

Essential

  • Degree level education
  • GLP (21 CFR part 58)
  • Quality management (ie. auditing experience in the quality standards)
  • Experience in pharmaceuticals or a related industry
  • Knowledge of corporate governance, health care regulations, laws and standards
  • Excellent analytical, written and oral communications skills
  • Strong collaborative, partnering, and interpersonal skills
  • Strong ability to work independently
  • Basic project management skills
  • High ethical standards, trustworthy, operating with absolute discretion

Desirable

  • Qualified professional - compliance

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.

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Associate Director GLP & Research QA
QA

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