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Associate Director/Director, QA Validation - Operations at AstraZeneca in Frederick, Maryland

Posted in Other 30+ days ago.

Job Description:

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 the QA Validation Associate Director / Director, you will be responsible to lead a high performing team that provides robust Quality Oversight to ensure that all new or modified systems and processes implemented at the FMC site are suitable for their intended Quality purpose and are maintained in this state.

**This role is posted as an Associate Director/Director based on experience**

Main Responsibilities:
  • Owns the Validation program and strategy
  • Quality oversight for the execution of Facility, Utility and Equipment system
  • Quality oversight for the execution of Computer Systems, Software, 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 New Product Implementation process for FMC
  • Direct QA resources in support of projects

An integral element of this role is the use of Quality Risk Based thinking and strategies that ensure both a robust defense of Quality, Compliance and Patient Safety while also allowing agile, efficient, flawless implementation of these new and/or modified systems and processes.

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. They will also facilitate the growth and development of QA Validation staff, provide strategic support to the Site Quality Head, for operational and long-term growth, and demonstrate excellent communication skills through internal and external channels. They will provide Validation strategy, leadership and guidance to the decentralized validation teams at the site coordinating the Validation efforts at the site.

  • Responsible for the successful operation of activities of major significance to the organization. Oversees daily operational activities while working with Site Quality Head to establish mid and long-term priorities and goals.
  • Apply extensive expertise as a generalist or specialist.
  • Possess working knowledge of: Cleaning Validation, Equipment Validation, Process Validation, Computer Validation, Operational Excellence / Lean Sigma, Quality Risk management, and budget management.

Problem Solving
  • Develop creative solutions to complex problems using available theories and knowledge.

Freedom to Act
  • Work is performed without appreciable direction.
  • Support organizational objectives, and interprets company policies.
  • Complete work is reviewed, from a mid-term perspective, for desired results.
  • Interpret and executes policies and procedures that typically affect subordinate organizational units.
  • Recommend modifications to operating policies.

  • Exhibit excellent decision-making skills.

Interpersonal Communication
  • Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal representatives concerning specific operations.
  • Frequent inter and intradepartmental collaborations.

Supervisory/Management Skills
  • Generally, accomplishes results through lower management levels.
  • Determine and establish organizational structures and supervisory relationships, subject to top management approval.

Minimum Requirements:
  • Bachelors: Scientific / Biotech / Pharmaceutical field of study. Advanced degree desirable.
  • Preferred 15+ years of biopharmaceutical industry experience.
  • Preferred 10+ years of Quality Assurance with a focus on NPI and Validation (Facilities, Utilities, Equipment, and Process Validation), including 3+ years managing individual contributors and other people managers.

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.