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Sr Director, Quality

Company: Emergent BioSolutions
Location: Canton
Posted on: April 3, 2021

Job Description:

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. The Senior Director of Quality is responsible for managing all Quality activities at one or more Emergent sites, e.g., Baltimore Bayview, Camden, Canton, Gaithersburg, Hattiesburg, Lansing, Rockville, and Winnipeg. --ESSENTIAL FUNCTIONS
Quality Organizations at each site location(s) report directly to the Sr. Director of Quality. This position is responsible for the promotion of quality awareness and continuous improvement at the site. The Sr. Director Quality is responsible for all quality assurance systems and the implementation of corporate policies and procedures at the specified site(s). He/She will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. He/She will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to achieve business objectives at the site(s). The Sr. Director Quality is a key member of the Site Leadership Team. This role is responsible for helping to lead teams across the site in an integrated way that supports the delivery of site business goals. He/She will be responsible for a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms. Quality responsibilities within the scope of this job include the following:--
--- Quality Assurance
--- Quality Control
--- GxP Compliance
--- GxP Training
--- Validation QA
--- Document Control Additional responsibilities include:--

  • Provide leadership and strategic direction to the specified quality site(s)
  • Develop staff to enhance capacity and ensure continuity of the Quality function
  • Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
  • Establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
  • Collaborate with all departments to ensure that quality standards and GxP compliance are met and maintained.
  • Develop and monitor appropriate metrics to track quality and process improvement.
  • Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
  • The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. MINIMUM EDUCATION, EXPERIENCE, SKILLS
    • BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred
    • Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies
    • Experience in a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms
    • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
    • Should have an excellent understanding of Quality requirements in both the US and EU.
    • Proven expertise in the design and implementation of quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization--
    • Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
    • Significant experience and knowledge in Quality areas (Quality Assurance & Quality Control including Validation and proven expertise in the design and implementation of quality processes in a world-class pharmaceutical/vaccine manufacturing organization.
    • Must have technical knowledge of product design, manufacturing, process design and improvement.
    • Must have a track record of success and a broad understanding of contemporary quality practices to the position.
    • Ability to effectively relate the quality functions to the business as a whole.
    • This position requires vaccination against different viruses including Vaccinia virus and Japanese Encephalitis virus There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
      -- Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
      -- Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
      -- Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
      • Stand shoulder to shoulder no matter what
        • We combine our best thinking and communicate openly to support each other.
        • Break through thinking
          • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
          • Own it always
            • Every person at Emergent is engaged and accountable for delivering on our commitments.
            • Compete where it counts
              • We set the right goals and respect each other as we conquer them together.

Keywords: Emergent BioSolutions, Canton , Sr Director, Quality, Executive , Canton, Michigan

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