Sr Director, Global Quality Engineering

Location
Gaithersburg, MD, US
Posted
Sep 15, 2020
Ref
661428300
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 Senior Director of Global Quality Engineering is responsible for the development and application of harmonized global Quality standards and guidance required for GxP facility and equipment capital projects across the Emergent network. This role will assure facility and equipment designs meet GxP requirements for operations, e.g., material and personnel flow, while addressing both internal and external stakeholder needs. He/She will hire and lead the appropriate Quality commissioning and validation resources to achieve qualification and licensing of equipment and facilities per defined schedules. This role will also collaborate with internal and external regulatory partners to support timely regulatory agency submissions and approvals.
This role will lead teams across the network in an integrated way to support the delivery of business unit goals. He/She will be responsible facilities and equipment accommodate a multi-product, multi-host environment and must be skilled in the design and execution of segregation and changeover controls between hosts and platforms.

ESSENTIAL FUNCTIONS
  • Define standards and align Quality approach for facility and equipment design and qualification across the network
  • Partner with BU representatives to assure an appropriate level of Quality support for capital projects
  • Project management for all Quality aspects of facility and equipment capital projects
  • Manage staff to qualify, validate, and commission equipment and facilities
  • Includes CSV and Data Integrity plans
  • Represent Emergent to both internal and external contract partners and Regulatory bodies for capital improvement projects
  • Write and review regulatory submission documents in support of capital project approvals
  • Provide leadership and strategic direction to the specified Quality and cross-functional teams
  • Develop staff to enhance capacity and establish Emergent as a thought leader in biopharmaceutical manufacturing
  • 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 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 (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred
  • Position requires a seasoned Quality 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 and Manufacturing practices as they apply to GxP facility, equipment, and process design, execution, and improvement
  • 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
  • Should have an excellent understanding of Quality requirements in both the US and EU
  • 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 Engineering) including Validation and Data Integrity
  • Proven expertise in the design and implementation of Quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization
  • Ability to effectively relate the Quality Engineering function to the business as a whole.
  • 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.