Director, Quality

Location
Gaithersburg, MD, US
Posted
Jun 19, 2021
Ref
735342200
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.

The Director, Quality is responsible for quality assurance activities in support of CDMO manufacturing and testing of toxicology and process characterization/development materials in Gaithersburg MD. QA oversight of testing of early phase GMP material may also be required. Both drug substance development and drug product formulation activities are in scope. The Director, Quality is a key member of the site leadership team and is responsible for a small team of direct reports.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Quality responsibilities within the scope of this job include the following:
o Quality Assurance
o Compliance
o Training
o Validation
o Document Control

Additional responsibilities include:
o Designs and implements phase appropriate quality standards for executing site activites
o Ensures that quality deviations and other nonconformances are fully investigated, with root cause and corrective actions identified and implemented
o Escalates quality issues in accordance with corporate requirements
o Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
o Engages with CDMO clients, as needed
o Collaborates internally and externally to achieve objectives and deliver quality outcomes
o Develops and monitors appropriate metrics to track quality and process improvement.

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 related fields
  • Position requires a seasoned Quality professional with a minimum of 10 years of experience in biopharmaceutical/ CDMO companies, with quality decision-making experience and knowledge of laboratory operations required
  • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product and process development, manufacturing and testing of process characterization and toxicology materials and testing of early phase GMP material
  • Must have track record of successful quality problem-solving
  • Demonstrated ability to coach and develop staff
  • Excellent verbal & written communication skills


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 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.

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