Vice President, R&D/Clinical Quality - Gaithersburg, MD | Biospace
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Vice President, R&D/Clinical Quality

MedImmune, LLC

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Location:
Gaithersburg, MD
Posted Date:
8/16/2017
Position Type:
Full time
Job Code:
R-006786
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location:
Gaithersburg, Maryland, United States
Job reference: R-006786
Posted date: Jul. 05, 2017
VP, Research & Development - Clinical Quality - Gaithersburg, MD

MedImmune is the global biologics research and development arm of AstraZeneca. We work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths.

As the VP, R&D - Clinical Quality, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.

Those who join the MedImmune team feel a sense of ownership about their future. They thrive with a recognized leader in biologics manufacturing. Here, you will join passionate professionals who advance science and technology to deliver products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities that encourage both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/metabolic disease and neuroscience. Explore a career in the biologics manufacturing field, as we strive to better more lives, more often, around the world.

Main Duties & Responsibilities:

Leads and directs the strategic direction of the R&D/Clinical Quality and BioVentures Quality Operations organization and is accountable and responsible for the design, development, execution and administration of a GxP Quality System meeting all Medlmmune and regulatory agency development and scale-up, combination products (e.g., design control), and clinical manufacturing Good Manufacturing Practices (GMP) compliance requirements. Responsible for the execution of the Medlmmune and BioVentures R&D/Clinical Quality System and associated support processes and will interface directly with Research, Development, Clinical Development and Operations senior I executive leadership teams to achieve support and compliance goals.

Requirements

Essential Requirements:

  • Bachelor's degree or greater in science, pharmacy, or manufacturing.
  • Fifteen to twenty years of experience with increasing levels of responsibility within the R&D/Clinical area. This includes hands on experience with managing regulatory inspections (FDA, MHRA, etc.) within the Clinical and R&D areas.
  • Twelve to fifteen years of management I leadership development experience.
  • Extensive working knowledge of US and Worldwide GxP regulations and experience with regulatory compliance inspections.
  • Global Compliance/QA experience at manufacturing sites outside the US on an ongoing basis. Extensive experience with GxP systems approaches and implementation of such systems.
  • Demonstrated ability to effectively lead professional staff; proven ability to work in a collaborative team environment across multiple technical functions.
  • Demonstrated ability to effectively interact with both global functional areas (GxP) and manufacturing sites (GMP) and third party vendors.
  • Strong project management and organizational skills.
  • Excellent interpersonal skills (including, listening, writing, negotiation, facilitation, attention to detail and presentation skills).

Desired Requirements:

  • Advanced degree (Ph.D.) in science, pharmacy or engineering preferred
  • Compliance/QA experience at a pharmaceutical I bio-pharmaceutical with specific antibody and vaccine experience preferred.

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.