Live Virus Vaccine Quality Operations Lead

Job Description

Our Quality organization ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Associate Director within Quality is responsible for providing Quality direction and oversight to one of our sites in the quality systems, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with Regulatory requirements.

The individual is an Advocate and Leader for the development, execution and deployment of the site and our priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems. The qualified candidate ensures compliance to Divisional, Company, and Site standards and procedures. The incumbent manages a team of Quality Specialists, responsible for elevating our compliance posture. This role partners with the Operations and Technical Operations Leaders to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements.

The qualified candidate must demonstrate strong analytical and scientific acumen to assist with troubleshooting of processes and systems. Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections.

Primary activities include but are not limited to:

1.) Directly leads activities in the execution of quality system functions relating to GMP compliance; additionally, champions multi-department teams regarding various compliance initiatives and assessments.

2.) Coordinates and directs a team of multi-disciplined professionals in areas of process and systems as they relate to support and enhancements of the quality system(s)

3.) Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Responsible for hiring and ensuring personnel are trained and performing per expectations.

4.) Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities.

5.) Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)

6.) Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums as well as strategic initiatives.

7.) Acquire and maintain technical process knowledge relevant to operations and testing. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations.

8.) Proactively partner to identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, improving safety and eliminate waste, while maintaining compliance.

9.) Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents.

Minimum Education Requirements and Experience:

• Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

OR

• Master’s degree in Science, Engineering, or another technical field with six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

Required Experience and Skills:

• Minimum two (2) concurrent years’ experience managing direct reports.
• Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

Preferred Experience and Skills:

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