Director, Quality Assurance

Baltimore (Camden), MD, US
Feb 01, 2021
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 Quality Assurance Director provides quality oversight and direction for the Camden Quality Systems & Compliance and Quality Operations functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the QA Director provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the QA Director ensures that there is a culture of quality and compliance through effective leadership and strict adherence to Emergent's core values.

  • Lead Quality Operations for the CDMO franchise to assure good alignment with client expectations and on-time batch delivery according to plan.
  • Develop and execute processes to achieve CDMO objectives. Define respective roles and responsibilities with CDMO clients and execute in a manner to build client trust and satisfaction.
  • Must have the knowledge and experience to provide strong leadership in support of cGMP manufacturing of biological vaccines, including thorough knowledge of and experience with: document control, batch release, deviation systems, CAPA, change control, product inquires/complaints, process / analytical / cleaning validation and qualification requirements.
  • Serve as Chairperson for the Material Review Board to assess deviation impact, investigation need and thoroughness of required investigations.
  • Maintain the site in an inspection ready state by regulatory agencies and clients.
  • Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables.
  • Develop strategic plans using a Quality Systems approach to accommodate department and Quality division growth and lead the QA team toward successful implementation and execution of the systems. Work effectively with corporate functions to align systems across multiple sites.
  • Manage and mentor Quality management staff to emphasize positional responsibility, personnel development and succession planning throughout the unit. Must be able to mentor Quality personnel in the necessary skills to review and approve highly technical documentation.
  • Provide direct oversight of activities related to participation in U.S. FDA (CBER) and other regulatory agency inspections.
  • Participate in interdepartmental/site leadership and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site. Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to teach intent and common industry implementation of the Quality Systems is essential. Ability to prioritize and multitask necessary.

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.

  • Bachelor's Degree in Biology, Chemistry, Engineering, or related fields
  • A minimum of eight (8) years of cGMP Quality experience (QA/QC/Validation)
  • A minimum of five (5) years in roles of increasing management responsibility in a biopharmaceutical manufacturing environment
  • Strong communication skills: oral/written and listening
  • Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
  • Interpersonal skills: team building, consensus building, conflict resolution

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.

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