Dir, Quality Compliance & Inspect. Readiness

Location
Gaithersburg, MD, US
Posted
Sep 12, 2020
Ref
667864200
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 Director of Quality Compliance & Inspection Readiness works with site personnel and management to ensure that the sites are continuously GxP inspection ready. This role ensures that Quality System requirements are appropriately applied to enable successful GXP inspections across the Emergent network.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Works with Site Leaders across the network to ensure site GxP inspection readiness for regulatory agency and client inspections
    • Identify and remediate potential GxP deficiencies
    • Provides training to enable understanding of continual inspection readiness
  • Provide structure and framework for inspection preparation
  • Engage with clients on process inspection readiness
  • Ensure facility, equipment, and process readiness for presentation to clients and regulators
  • Ensure systems and operations are designed, scaled, and executed to meet GxP requirements for high volume operations and can withstand the scrutiny of regulatory challenges
  • Enable successful client EUA, NDA, and BLA filing and licensing inspections with respect to GxP compliance
  • Demonstrate leadership competencies for effective collaboration and accountability

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
The ideal candidate will have:
  • BS degree in Engineering, Science, or Operations Management; Advanced Degree (s) preferred
  • Familiarity with regulatory requirements in the US and EU
  • Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in biopharmaceutical companies
  • Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations
  • Has an excellent understanding of Quality requirements in both the US and EU
  • Proven expertise in the design and implementation of quality processes in a world-class pharmaceutical manufacturing organization
  • Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance
  • Must have technical competence and knowledge of drug/device product design, manufacturing, process design and improvement and act as an open and accessible resource to peers
  • Must have a track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms.
  • Extensive relevant experience applying Quality risk management for drug device product development and manufacturing
  • Experience in start-up of commercial operations. Bridging products from development to commercial stage
  • Exceptional interpersonal skills with the ability to negotiate and resolve conflict with poise, tact and diplomacy
  • Ability to effectively integrate the quality functions into the business
  • 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.