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Vice President, Quality Operations

Company: GreenLight Biosciences, Inc.
Location: Medford
Posted on: January 13, 2022

Job Description:

ABOUT GREENLIGHT GreenLight Biosciences solves big problems facing society in agriculture, human health, and animal health through scientific innovation. GreenLight Biosciences is dedicated to bringing our cell-free RNA production process to market. Our work will lead to more sustainable global development, and we promise to deliver our safe solution without compromising the Earth and its people. One of the small coterie of early RNA-focused biotech startups, GreenLight Biosciences was founded in 2008, raised its-- -most recent round this year-- -and has a broad portfolio addressing key issues in plant health and human health. The GreenLight team is over 200 people across our headquarters in Medford, MA, an R&D facility in Woburn, MA and an R&D facility in Research Triangle Park, NC. GreenLight also has a pilot scale biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity,-- -protect bees and other pollinators, treat rare diseases such as-- -Sickle Cell Disease-- -as well as develop-- -vaccines for seasonal flu and the current COVID-19 pandemic.-- - At-- -GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity's challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery.-- -Fueled by our aspiration-- -for-- -a-- -true-- -sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone"-- - -paving the way for a sustainable future.-- -For more information, visit POSITION 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. MAJOR RESPONSIBILITIES 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 EDUCATION 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 departmentsProven ability to collaborate and navigate a matrix organization structure to influence without direct reporting relationships CRITICAL COMPETENCIES FOR SUCCESS Drives results: Strong bias for action and execution. Sense of urgency and focus on improving business results; ability to solve problems in a way that consistently meets or exceeds established goals; exploits opportunities to exceed goals and works towards them, even under adverse circumstances; motivated by creating better ways of doing things, so that higher levels of performance are possible. Embraces the principles of equality, diversity, and inclusion: Demonstrated ability to creates an inclusive and safe environment where team members can contribute to their full potential. Develops a powerful sense of shared purpose that motivates the team to achieve higher levels of performance. Inspires others with or without direct reporting lines. Adept at working across functional and cultural boundaries to positively impact business performance. Embodies Collaboration: Demonstrates a highly collaborative leadership style by balancing between an entrepreneurial spirit and business development mind-set, i.e. both the ability to operate comfortably in a start-up environment and the requisite ability to deal with ambiguity. Proactively communicates with the stakeholders and teams about value generation, market trends and insights, and all issues related with business development. Role model for integrity and honesty: Has the highest standards of integrity and honesty. Does the right thing and models our culture. Will be a spokesperson for the agriculture business and the candidate's personal brand will have a direct positive impact on GreenLight's brand. Greenlight Biosciences Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. GreenLight requires proof of COVID-19 vaccination for its employees consistent with OSHA guidelines. -- -

Keywords: GreenLight Biosciences, Inc., Medford , Vice President, Quality Operations, Executive , Medford, Massachusetts

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