Quality Systems and Strategy Director

Profile

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ABOUT GREENLIGHT

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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 ****rel=no-follow>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, ****rel=no-follow>protect bees and other pollinators, treat rare diseases such as ****rel=no-follow>Sickle Cell Disease as well as develop ****rel=no-follow>vaccines for seasonal flu and the current COVID-19 pandemic. 

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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 ****Descriptions/****rel=no-follow>****the position:

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The GreenLight team is looking for a high-performing, self-motivated individual who works well in a fast-paced environment to join the Quality Leadership Team. The company is looking for a key individual to play a pivotal role in advancing breakthrough therapies to rapidly address emerging pathogens. Reporting directly to the VP of Quality, the individual will be a key leader of our Life Science Team responsible for the implementation and continuous improvement of a phase appropriate Quality Management System. The Ideal candidate would also have demonstrated the ability to develop an integrated strategic roadmap and build the required execution plans for realizing the corporate Quality strategy.

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Key Position Responsibilities

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• Experience with drug development and commercial Quality systems focused on the development, manufacture and delivery of small molecule, biologic or advanced (gene) therapy.
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• Leads risk assessment and mitigation activities to establish and improve the Quality Management System, working cross functionally to align the approach to quality and compliance across the organization.
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• Employ phase appropriate, life cycle management strategies to develop, implement and maintain the GLB Quality Management System and associated enterprise systems and processes.
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• Actively listen to, partner, collaborate and cooperate with Quality subfunctions and functional area leads to assure process needs and requirements are met to drive transformative change, efficiency, performance, and compliance.
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• Provides functional leadership including hiring and managing a professional, high performing QA staff designed to meet the technical and compliance requirements of a growing company.
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• Provide support where needed to ensure adequate oversight of all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues.
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• Collaborates with internal and external stakeholders and partners to ensure that phase-appropriate GxP quality assurance requirements are met.
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• Review and approve quality system documents (e.g., executed batch records, GxP analytical assay data packets, pre/post-execution validation protocols, etc.)
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Position Requirements

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• Bachelors degree or higher in a scientific or technical discipline relevant to the life sciences and biopharma areas.
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• 10 years of quality assurance experience and 5 years management experience in a GxP-related industry.  Experience in a drug development or biological product manufacturing organization is highly preferred.
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• Working knowledge of the process hand-offs occurring during product development (i.e., research practices to engineering runs to toxicology runs to phased clinical trial runs to commercial manufacturing).
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• Advanced working knowledge and experience with practical implementation of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
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• Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a highly collaborative environment.
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• Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
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• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
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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.

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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.

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GreenLight requires proof of COVID-19 vaccination for its employees consistent with OSHA guidelines.

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Company info

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