This role will be part of the growing Human Health Quality group that enables all Human Health teams to work compliantly and effectively to deliver GreenLight’s commitments, internally and externally. The position will have oversight for the Quality Function and require an individual highly knowledgeable in vaccines/ biologics CMC & GMP Quality System best practices, with the proven ability to thrive in a fast-paced environment.
This role requires someone with excellent leadership and teambuilding capability, as well as well-established expertise in implementation of Quality Management Systems. The successful candidate will be a highly resourceful individual with strong emotional intelligence, self-motivation, and strong analytical and execution skills.
- Provide direct leadership and direction to the GreenLight Quality Assurance department and Quality Control department
- Oversee the finalization and maturation of GreenLight’s Quality Management System and ensure that phase appropriate quality systems, objectives, metrics, and milestones are established and are comprehensive of the full product lifecycle including support and Quality oversight of external CRO or CMOs
- Author and review applicable CMC sections of filings, as needed.
- Proactively interface with global health authorities, as needed, driving conversations and decisions to support GreenLight’s mission and aggressive timelines
- Establish and maintain a Quality Plan that will provide the required compliance backbone to help enable GreenLight’s mission and ambition
- Set and align goals and objectives for the QA and QC departments with the overall corporate goals and objectives
- Participate in strategic planning and plan implementation, as well as business optimization, to help assure the success of GreenLight
- Quickly identify and assess compliance issues, internally or at CRO, CMO, and CDMO’s, and guide and oversee any remediation activities as necessary
- Identify and interpret regulations, directives, guidelines, and other pertinent information issued by applicable global regulatory agencies and other regulatory organizations as they pertain to the quality program and compliance activities
- Define and implement GreenLight’s Quality computer systems, as the company grows
- Ensures the review and audit of internal department processes for compliance with applicable regulations or guidelines.
- Mentorship responsibility for Quality staff as well as peers in all quality related matters
- Requires advanced degree in a scientific or operational discipline or equivalent combination of education and experience relevant to the life sciences and biopharma areas.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS
- 20+ years of experience in biopharmaceutical manufacturing
- 15+ years of experience in quality operations leadership (QA, QC, Quality Systems) within biopharmaceutical industry
- Ability to navigate a fast-paced environment with a high degree of ambiguity
- Proven ability to implement risk-based approaches to Quality systems and processes
- Mission-driven and embraces the principles of equality, diversity, and inclusion; passionate about GreenLight’s values and objectives
- Excellent working knowledge, understanding and experience with the practical implementation of Quality Systems (FDA QSIT,ICH Q10, etc.) and how those systems are implemented in cGLP and cGMP environments to meet FDA , EMA and other foreign agency requirements
- Experience supporting multiple regulatory filings (e.g., INDs, BLAs, etc.) and leading product-related inspections for US and foreign regulatory agencies
- Excellent communication skills, with the ability to influence and engage across all levels of the corporation from the Board of Directors to the lab bench and with external stakeholders
- Ability to negotiate and achieve alignment with executive management and external audiences at the highest levels, including regulatory agencies
- Experience developing, implementing, and executing strategic plans and objectives for quality organizations and departments
- Proven ability to collaborate and navigate a matrix organization structure to influence without direct reporting relationships