1. JOB SUMMARY

The Director, Quality Assurance-Operations provides quality oversight and direction for the Rockville sites 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 core values.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the 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: Document control, batch release, deviation systems, CAPA, change control, produce inquires/complaints, processnalytical/ cleaning validation, and qualification requirements.
• Responsible for Quality oversight of cGMP activities related to the manufacturing of product for commercial distribution including on floor oversight, coordination of Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release and Change Control initiations, reviews, or approvals.
• Quality Assurance lead and approver in authoring or reviewing of various compliance documentation such as deviations, CAPSs, change controls and other cGMP compliant documentation.
• Serve as Quality Lead for materials and batches to assess deviation impact, investigation needs and thoroughness. Provide Quality oversight and final disposition of product for distribution for multiple markets including US FDA and EU. Provide Quality oversight and final disposition of shipment disposition. Lead QRB discussions for critical deviations
• Prepare trend reports and summaries for routine Quality Management Review. Communicates metrics, trends, and data summaries to senior management as part of Management review.
• Challenge current procedures and practices to afford optimization and further development of existing quality standards and overall compliance.
• Provide oversight and manage Emergents product inquiry and product compliant system.
• 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 for future department Quality division growth and lead the QA team toward successful implementation and execution of the system. Work effectively with corporate owners 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 team to resolve issues and elevate as appropriate. Ability to reach 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 managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelors Degree in Biology, Chemistry, Engineering, or related fields.
• 10-12 years of cGMP Quality experience (QA/QC/Validation)
• At least 8 years in roles of increasing management responsibility in a biopharmaceutical manufacturing environment.
• Experience with extensive participation in Regulatory Inspections.
• Excellent understanding of Quality Systems requirements
• Strong interpersonal and communication skills
• Strong oral/written and listening skills.
• Strong problem-solving skills
• Self-awareness, integrity, judgement, vision, and adaptability are key
• Interpersonal skills: team building, consensus building, conflict resolution
• Sound understanding of regulated activities, health authority expectations, and GxP
• Experience developing and executing large scale organizational change, including change management strategy and planning
• Proven ability to understand complex processes/problems and facilitate coach teams to optimal solutions
• Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset
• Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.