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Sr. Director of Quality Operations

  • Job type: Permanent
  • Location: North Carolina
  • Salary: Negotiable
  • Job reference: 157991/001_1541523733
  • Sector: Quality Control, EPM Scientific
  • Date posted: 06/11/2018

JOB DESCRIPTION:

The Sr. Director, Quality Operations will successfully manage and direct the activities of the Quality Assurance, Quality Compliance, Quality Support, Quality Control and Microbiology departments as well as to directly supervise the activities of the respective managers. This position is an experienced and entrepreneurial leader that will develop Quality strategy, make decisions based upon relevant data and Good Manufacturing Practices (GMPs). This position will hold the site and team responsible for meeting commitments and enhancing customer experience.

KEY RESPONSIBILITIES:

  • Responsible for the management and supervision of Quality Assurance by assisting in the development of goals and key performance indicators, providing leadership for Food and Drug Administration (FDA) audits as well as regulatory awareness programs for each agency, assisting with the FDA and other audit response teams and assisting in the development of Good Manufacturing Practices (GMPs) for all departments.

  • Organize key staff elements and direct Quality Assurance and Quality Control functions to achieve site goals and customer expectations while maintaining compliance to corporate standards and the various regulatory agencies around the world. Directly maintain Food and Drug Administration (FDA) / Medicines and Health Products Regulatory Agency (MHRA) and other agency compliance statuses.

  • Active & collaborative member of the site leadership team, operational leadership team, and support the management team where required. Ensure that all parties interacting with technical support are aligned in shared tactical & strategic approaches. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

  • Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups. Interact with key clients and provide resolution to customer issues and concerns.

  • Select, manage and develop the Quality Operations staff to ensure the efficient and effective operation of the Quality function.

  • Establish the strategic plans and objectives for the site Quality organization by making final decisions on administrative and operational matters against Company Quality Standards.

QUALIFICATIONS:

  • 8+ years of senior Quality leadership experience required.

  • Superior cGMP experience and leadership required.

  • Oral Solid Dose (OSD) and/or Sterile Fill Drug Product experience highly preferred.

  • BS or higher in chemistry, pharmacy, microbiology required.

  • Advanced change management skills are vital.

  • Must have extensive and successful people management & development skills.

  • Must be able to interact with and influence the most senior levels of the organization.

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