Live Virus Vaccine Quality Operations Lead

Job description

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: Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk. Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm. Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes. Demonstrated experience of interacting with site, divisional or regulatory audits Demonstrated ability to create an engaged workforce using Inclusion as the How Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion. MPS experience - LSS Green Belt certification or equivalent experience. Demonstrated success with Talent Management including leading and mentoring Proven ability to manage multiple projects simultaneously. Applies knowledge of internal/external business challenges to improve products, processes, or services. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Demonstrated self-starter with capability to develop innovative solutions to challenges. Aseptic/sterile processing experience Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing Required Skills: Achieving Objectives, Achieving Objectives, Adaptability, Aseptic Handling, CAPA Management, cGMP Regulations, Compliance Analysis, Compliance Risk Management, Continuous Improvement Techniques, Corrective Action Management, Critical Thinking, Deviation Management, GMP Compliance, Government Regulation, Leadership, Master Batch Records, People Leadership, People Management, Production Management, Quality Assurance Systems, Quality Control Management, Quality Control Systems, Quality Management Systems (QMS), Quality Manuals, Quality Risk Management {+ 8 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action r