VP, Quality, CDMO Business Unit

Location
Gaithersburg, MD, US
Posted
Sep 06, 2020
Ref
658743300
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
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.

JOB SUMMARY

The VP of Quality, CDMO Business Unit (BU) is responsible for leading all CDMO-related quality activities at one or more Emergent sites currently including Baltimore, MD (two sites), Rockville, MD; and Canton, MA. Quality personnel serving the CDMO BU at each site location will have direct and/or indirect reporting to the VP of CDMO BU Quality. This position has several direct reports in a group of 150 professionals and reports to Emergent's SVP of Quality.

The VP, CDMO Quality is a key member of CDMO BU leadership responsible for building, leading and executing a quality strategy that supports the following:
  • Contract partner relationships;
  • Quality process design and development;
  • Product and facility approval;
  • Sustainable manufacturing;
  • Supply through in-house capabilities and well as third-party development; and
  • External manufacturing partners.

The position provides strategic direction and oversight for quality systems as well as the implementation of a quality framework to support the CDMO BU businesses globally. The role will ensure that internal processes and metrics are aligned to create a high level of process consistency, product quality and customer satisfaction. The position will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to achieve business objectives for the BU. The role works with and through the Heads of Site Quality to accomplish these goals.

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 CDMO BU 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. This role will create an agenda in support of the business mission and move people to it.

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

ESSENTIAL FUNCTIONS
  • Define strategic direction and quality objectives for the CDMO 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
    • Develop and implement quality systems to support multi-product, multi-platform/host processes and production of both viral and non-viral products at the sites
    • Create and sustain processes that align Emergent requirements and Contract Partner expectations
      • Document review and approval
      • New Product Introduction
      • Investigations
      • Changeover
      • Change control
    • 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 contract partners, 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
    • Provide support and oversight for validation, changeover, analytical and process development, and premarket activities as required to distribute vaccines and drug products
  • Partner with the OE and IT functions 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 CDMO BU leadership to define and drive BU objectives; and serve as the CDMO BU representative on the Global Quality Leadership Team (GQLT)
  • Determine organizational structure and headcount requirements to effectively staff the quality functions strategically and prospectively, working with quality site leaders, to ensure the appropriate level of quality support to CDMO customers
  • 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
  • Represent Emergent in due diligence processes
  • 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

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • 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 CDMO supply operations, product development, clinical manufacturing, and commercial operations in a world-class pharmaceutical/vaccine manufacturing organization
  • Ability to collaborate successfully and work through others to accomplish site, BU, and corporate goals
  • Must have technical competence and knowledge of drug/device product design, manufacturing, process design and improvement. Previous experience establishing and/or enhancing effective (CDMO) 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 external customers, 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 clients and 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


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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 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.