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Director, External Quality Operations

Emergent Biosolutions
United States, Maryland, Gaithersburg
January 14, 2023

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world.Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

Job Summary

Reporting to the VP, External Quality, the Director supports the efficient operation and management of the External Quality group by driving quality process standardization, harmonization, maintenance, and continuous improvement, tracking and reporting on risks, managing metrics definition, analysis, and reporting, and supporting M&A diligence and acquisition integration. This role will also coordinate the development of annual External Quality goals and budgets in alignment with Global Quality and Corporate objectives and priorities.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

The Director is responsible for:

  • Providing leadership within External Quality and working collaboratively with stakeholders to ensure quality processes support business objectives
  • Ownership of quality systems directly supporting External Quality
  • Lead standardization, harmonization, and continuous improvement of External Quality processes
  • Lead implementation of Quality Management System (QMS) improvements in collaboration with global stakeholders to achieve strategic Quality priorities
  • Represent ExternalQuality on Global QMS improvement teams
  • Ownership of the External Quality Management Review process and all associated quality metrics as well as reporting/roll up to the Global QMR
  • Lead implementation of quality risk management in support of External Quality operations and quality systems
  • Identify, assess, communicate, manage, and mitigate quality system risks to maintain a state of inspection readiness
  • Tracking and reporting on risks across Emergent's external manufacturing network
  • Evaluating new or revised regulations and driving any necessary quality system changes to ensure sustained compliance
  • Support GxP audits and inspections and manage SQM processes for External Quality
  • Provide support, as assigned, to M&A diligence activities and to quality integration of acquired assets including transfer of quality records, assessment, planning, and execution ofquality systems alignment (when/where necessary), product and process knowledge transfer to responsible quality authority, initial set up of quality oversight model for externalmanufacturing partners and supply chain
  • Coordinating annual budgeting and goal setting processes for External Quality organization

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.

Education, Experience, & Skills

  • Bachelor's Degree in science, engineering, nursing, or other health or scientific-related discipline
  • 7-10 years broad experience working within international GMP regulations for drugs and/or devices including ICH Guidelines, ISO 13485, FDA 21 CFR Parts 210, 211 and 820,and EU and Health Canada GMPs

    • Experience in Pharma or Med Device development and manufacturing is preferred

  • Minimum 10 years of progressive leadership experience
  • Strong experience with quality systems development, management, and improvement
  • Experience as process owner for deviation, CAPA, change management, and self-inspection programs as well as managing 3rd party audits and inspections is preferable

    • Experience with quality risk management will be considered an asset

  • Must have ability to work independently
  • Ability to manage multiple priorities and tasks in a dynamic environment
  • Excellent communication skills, both written and verbal
  • Ability to exercise judgment to determine appropriate corrective actions
  • Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
  • Ability to use computer programs

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 .

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.

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