Associate Director, QA Validation - (Frederick, MD)

  • Company: MedImmune
  • Location: Frederick, Maryland
  • Posted: November 23, 2017
  • Reference ID: R-017574
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Associate Director, QA Validation in Frederick, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
Main Duties and Responsibilities
As an Associate Director, QA Validation, you will be responsible for all assigned aspects of Quality Assurance at the Frederick Manufacturing Center associated with:
  • Owning the Validation program and strategy
  • Quality oversight for the execution of Facility, Utility and Equipment system
  • Quality oversight for the execution of Automation qualification and validation commissioning and qualification
  • Quality oversight for the execution of Cleaning and Process validation
  • Quality assessment and approval of process and systems changes
  • Quality oversight of NPI process for FMC
  • Direct QA resources in support of projects
You will provide leadership, direction and mentoring to ensure that the QA organization is successful in meeting the quality and manufacturing objectives in support of site goals.  You will represent the QA department and or the Quality Organization on assigned site governance and operational teams internally, and as an empowered functional representative externally to ensure deliverables are aligned with site business objectives.  You will also facilitate the growth and development of QA Validation staff, provide strategic support to the QA Director, Compliance and Site Support, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels.  You will provide Validation strategy, leadership and guidance to the decentralized validation teams at the site coordinating the Validation efforts at the site.
Essential Requirements
  • You will be responsible for the successful operation of activities of major significance to the organization.  You will oversee daily operational activities while working with Director to establish mid and long-term priorities and goals.
  • You will apply extensive expertise as a generalist or specialist.
  • You will possess working knowledge of: Cleaning Validation, Equipment Validation, Process Validation, Computer Validation, Operational Excellence / Lean Sigma, and budget management.
Preferred Education/Experience
  • Bachelors:  Scientific / Biotech / Pharmaceutical field of study.  Advanced degree desirable.  Preferred 15+ years of biopharmaceutical industry experience, 10 years minimum. 
  • Preferred 10+ years of Quality Assurance with a focus on NPI and Validation (FUE and Process Validation), including 3+ years managing individual contributors and other people managers.
Desirable Requirements
Problem Solving
  • You will develop creative solutions to complex problems using available theories and knowledge.
Freedom to Act
  • Your work is performed without appreciable direction. 
  • You will support organizational objectives, and interprets company policies. 
  • You complete work is reviewed, from a mid-term perspective, for desired results. 
  • You will interpret and execute policies and procedures that typically affect subordinate organizational units. 
  • You will recommend modifications to operating policies.
  • You will exhibit excellent decision-making skills. 
Interpersonal Communication
  • You will have frequent contact with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts.  You will conduct briefings and participate in technical meetings for internal representatives concerning specific operations.
  • You will have frequent inter and intradepartmental collaborations.
Supervisory/Management Skills
  • You will generally accomplish results through lower management levels. 
  • You will determine and establish organizational structures and supervisory relationships, subject to top management approval. 
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.

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