Sr. Director, Global Quality Systems Governance

Location
Gaithersburg, MD, US
Posted
Sep 11, 2020
Ref
659979800
Discipline
Quality, Quality Control
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 Sr. Director of Global Quality Systems Governance will oversee the deployment of Emergent BioSolutions Inc. (EBSI) Quality Management System (One QMS) framework across the GxP lifecycle. The position will oversee the definition, execution and performance of EBSI's QMS including defining, implementing and overseeing execution of the framework, provide leadership and guidance to Business Process Owners (BPOs) in design/development of their respective quality system(s). The position will be responsible to achieve an effective, efficient and continuously improving One QMS ultimately leading to EBSI ISO certification.

ESSENTIAL FUNCTIONS
  • Lead annual global quality planning activities, to drive quality performance and quality across GxPs
  • Leads the development and execution of EBSI's enterprise wide QMS Governance Controls and related strategic, transformational and continuous improvement objectives.
  • Ensure QMS framework processes are established, implemented, audited, and continuously improved.
  • Establish and lead QMS Governance Board ensuring a platform for the voice of impacted stakeholders, prioritization of deliverables against business strategy, and transparency of the health of systems across the enterprise and within the impacted functions.
  • In collaboration with Quality System Business Process Owners, develop project/change management and communication plans and documents to ensure stakeholder engagement and progress as quality systems are changing/continuously improving.
  • Ensure clear, concise, regulatory compliant policies, procedures, are defined and implemented through the correct implementation of EBSI's Enterprise One QMS framework.
  • Serve as a change agent for enterprise mindset (EBSI's One QMS harmonization) efforts across sites, functions, and business units promoting positive behavioral change.
  • Define metrics to measure and report on process adoption/compliance (e.g., gap assessment tracking).
  • Ensure timely and accurate reporting via Quality Review Boards/Management Review on the performance of EBSI's One QMS along with associated needed improvements.
  • Participate in quality system process optimization core/extended team meetings as required.
  • Collaborate with training teams to provide insight and guidance on the planning and implementation of quality system related process training.
  • Lead cross functional teams consisting of representatives to ensure continuous improvement of the governing QMS framework processes and related technologies.

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
  • Degree level in Life Sciences and/or Information Systems, Advanced degree and/or MBA an advantage
  • People management experience (direct/matrix).
  • 10-12 years of experience in the Biopharma/Pharmaceutical industry with cross-functional experience in quality systems
  • Excellent leadership, interpersonal, communication, negotiation and problem-solving skills
  • Sound understanding of regulated activities, health authority expectations, and GxP.
  • Excellent organizational awareness (e.g., Research & Development, Commercial Manufacturing, interrelationship of departments, business priorities), including significant experience working cross-functionally and in global, cross- cultural teams.
  • Experience developing and executing large-scale organizational change, including change management strategy and planning.
  • Proven ability to understand complex processes/problems and facilitate coach teams to optimal solutions
  • Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
  • Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.


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.