VP, Quality, Vaccines (27963)

Emergent BioSolutions in Gaithersburg, MD

  • Industry: Executive Management - Engineering/Production
  • Type: Full Time
position filled

Req Id27963-Posted09/18/2019-United States-MD-Gaithersburg-Quality-Regular Full-time

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.

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.

TheVP of Quality, Vaccines and Anti-Infectives (VAI) is responsible for managing all VAI related Quality activities at one or more Emergent sites including Bern, Switzerland; Canton, MA; Gaithersburg, MD 300P; Lansing, MI; and San Diego, CA. Quality personnel serving the VAI business unit (BU) at each site location will have direct and/or indirect reporting to the VP of VAI Quality. This position has 5 direct reports in a group of 169 professionals and reports to Emergents SVP of Quality.

Position Summary
The VP, VAI Quality is a key member of VAI leadership responsible to craft and execute a Quality strategy that supports product design and development, product approval, sustainable manufacturing, and supply through in-house capabilities as well as third-party development and manufacturing partners.

The position provides strategic direction and oversight for quality systems as well as the implementation of corporate policies and procedures at VAI businesses globally. 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).

This role maintains a comprehensive and contemporary understanding of GxP/ISO regulations and approval strategies for vaccines and drug products to support sustainably compliant and operationally excellent development and manufacturing of VAI products. The VP is responsible for leading teams across site(s) in an integrated, cross-functional way that supports GxP principles in the delivery of business unit goals. He/she will create an agenda in support of the business mission and move people to it.

The VP serves as a mentor and coach to Quality management personnel, modeling behaviors and leadership aligned with Emergent company values.

Quality responsibilities within the scope of this job include the following:

Duties and Responsibilities

  • Define strategic direction and Quality objectives for the VAI BU
    • Scope includes Development and Manufacturing sites with Quality Assurance, Quality Control, GxP Compliance, GxP Training, Validation, and Document Control functions
  • Develop and maintain Quality processes and competencies to drive a culture of compliance and collaboration
    • Lead the development and consistent application of quality processes aligning policies and procedures with internal and outsourced activities
    • Promote quality awareness and continuous improvement at the sites
    • Develop the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals
    • Develop Quality management systems in conformance with ISO, FDA, and EU regulatory standards
    • Enable formal risk assessments processes to identify compliance risks and appropriate mitigation strategies
    • Provide Quality standards for product lifecycle management
    • Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, regulatory affairs, and other areas as required
    • Collaborate with all departments and functions to ensure that quality standards and ISO/GxP compliance are met and maintained
    • Partner with the IT function to drive "Lean" initiatives and process improvements for Quality Information Management Systems to support the objective of compliant paperless enterprises.
  • Serve as a senior contributor in VAI leadership to define and drive BU objectives; and serve as the VAI representative on the Global Quality Leadership Team (GQLT)
  • Determine headcount requirements to effectively staff the Quality functions strategically and prospectively
  • Staff the organization to fulfill development and market distribution of products
  • Ensure appropriate Quality support to CMO and component suppliers
  • Responsible for oversight of BU Quality operating plans and budgets
  • Provide coaching and mentoring to ensure succession and business continuity
  • Provide subject matter expertise for resolution of multi-variant problems
  • Partner with the Development functions to support early stage product development
  • Provide support and oversight for clinical studies and premarket approval as required for marketing vaccines and drug products
  • Maintain good application of compliance standards to enable excellent relationships with Regulatory agencies
  • Build strong relationships with internal and external customers to build, enhance, and ensure quality awareness
  • Develop and monitor appropriate metrics to track quality and process improvement
  • Other duties may be assigned

    Position Requirements
    Education & Experience
    The ideal candidate will have:
  • BS degree in Engineering, Science, 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
  • Must have a track record of success and a broad understanding of contemporary quality processes as they apply to product development, clinical manufacturing, and commercial operations in a world-class pharmaceutical/vaccine manufacturing organization
  • Must have technical competence and knowledge of drug/device product design, manufacturing, process design and improvement
  • Previous experience establishing and/or enhancing effective development and commercial GxP quality infrastructure and systems compliant with US and international requirements
  • Experience in start-up of commercial operations and bringing products from development to commercial stage
  • Proven ability to successfully establish and manage Quality staff (GMP and GCP), across multiple countries including the EU region
  • Ability to effectively integrate the quality functions into the business as a whole
  • Has an excellent understanding of Quality requirements in both the US and EU with extensive knowledge of GCP, GLP, and GMP regulations
  • Direct experience interacting with US and international regulatory authorities for pre-approval and post-approval inspections
  • Strong management and interpersonal/communication skills and the ability to negotiate and collaborate effectively with a variety of functions and personnel including medical, scientific, commercial and operational staff
  • Exceptional interpersonal skills with the ability to negotiate and resolve conflict with poise, tact and diplomacy and act as an open and accessible resource to peers
  • Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance
  • Proven ability to be agile and succeed in a fast-paced environment
  • Excellent verbal & written communication skills

    Ability to travel approximately 20 25% as needed to other site locations, events, etc.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.

Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

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