Director, Quality Assurance-Operations
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.
I. JOB SUMMARY
The Director, Quality Assurance Operations provides quality oversight and direction for the Bayview quality operations function to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the QA Operations Director provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, this role ensures that there is a culture of quality and compliance through effective leadership and strict adherence to Emergent’s core values.
II. ESSENTIAL FUNCTIONS
• 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: Batch release, deviation systems, CAPA, change management, product inquires/complaints, process / analytical / cleaning validation, and qualification requirements.
• Serve as Quality Lead for materials and batches to assess deviation impact, investigation needs and thoroughness.
• 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 and lead the QA team toward successful implementation and execution of the systems. Work effectively with corporate owners to align systems with corporate quality standards.
• 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 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s Degree in Biology, Chemistry, Engineering, or related fields
• A minimum of ten (10) years of cGMP Quality experience (QA/QC/Validation)
• A minimum of eight (8) 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
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.