Director Strategic Advice - Gaithersburg, MD | Biospace
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Director Strategic Advice

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
9/22/2017
Position Type:
Full time
Job Code:
R-012671
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Job reference: R-012671

Posted date: Aug. 16, 2017

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 Strategic Advice 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.

Main Duties and Responsibilities

As a Director, Strategic Advice, you will be leading global QA activities for an area of significant compliance risk in GXP arena (e.g. therapeutic or functional area, pharmacovigilance, vendors etc.) and support key strategic business initiatives to embed a quality mindset across the early and late stage clinical development organizations. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

You will be responsible for leading the QA support of Project Teams, Therapeutic Area, Functional Area and other Stakeholders (as applicable) by providing proactive strategic and quality planning activities (also known as ‘quality by design’), as required. You will be responsible for leading QA management of Quality Issues and investigations as well as providing strategic quality input to projects teams to ensure successful regulatory submissions and inspections.

As a Director, Strategic Advice you will provide advice on CAPAs and support Stakeholders to ensure timely resolution. You will support quality and GXP compliance risk management for allocated areas, using risk framework standards to define risk and develop mitigation recommendations. You will pro-actively work to promote the quality vision with Stakeholders and ensures your tasks are performed to current practices and in accordance with company standards and policies.

Requirements

Essential skills

  • Significant experience in pharmaceuticals or a related industry
  • Strong knowledge in GXP requirements, especially GCP
  • Knowledge and experience of corporate governance, regulations, laws and standards
  • Excellent analytical, written and oral communications skills
  • Strong collaborative, interpersonal and influencing skills
  • High ethical standards, trustworthy, operating with absolute discretion

Desirable skills

  • Quality Management
  • Project Management
  • Active Management of Risks & Opportunities
  • Business Relationship Management
  • Change Enablement
  • Influencing & Negotiating
  • Process Management & Continuous Improvement
  • Regulatory Environment Insight

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