Quality Assurance Manager

About Green Light Biosciences

Green Light Biosciences is using RNA to create a world where plants, people, and the planet can thrive together. The company develops highly effective agricultural solutions for farmers and beekeepers that target specific pests and degrade quickly in the environment. Our pipeline includes products to protect honeybees and a range of fruits and vegetables. The Green Light platform allows us to research, design, and manufacture across multiple product categories, including insecticides, fungicides, and herbicides.

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The Green Light Biosciences team is looking for a self‑motivated individual who works well in a fast‑paced environment to play a pivotal role in Quality Assurance for manufacturing crop protection products (CPPs) and GMP‑compliant manufacturing of veterinary medicines. Reporting directly to the Global Director of Quality Assurance, this individual will be a key contributing member of the manufacturing organization and is expected to be a hands‑on problem solver.

The candidate will assist with maintenance of QMS systems and governing SOPs as well as the review of executed manufacturing documents (e.g., batch records, QC data, validation protocols, etc.) at pilot and commercial manufacturing sites. Additional responsibilities may extend to auditing, monitoring, and support of QA activities at third‑party contract manufacturing facilities.

The ideal candidate will have experience with document control and quality systems in a regulated industry setting (e.g., 21 CFR 210/211, 40 CFR 158/160, Eudralex Volume 4, ISO 9001).

• Manage daily operations of the Quality Assurance team in Rochester, NY.
• Create, implement and maintain standard operating procedures, protocols, reports, etc., consistent with ISO and GMP protocols.
• Review and approve quality system and batch‑related documentation (e.g., cGMP procedures, batch records, QC testing, Certificates of Analysis, protocols, validation reports, stability studies, etc.)
• Initiate and support the management of CAPAs, deviations and investigations as well as monitor completion of such quality compliance activities.
• Provide Quality Assurance support to cross‑functional teams including Manufacturing, Warehousing, Contract Manufacturing and Quality Control departments.
• Provide mentoring and training to staff that are new to regulatory requirements and to facilitate their use of established quality systems.
• Collaborate with internal and external stakeholders to ensure that regulatory and quality assurance requirements are met.
• Oversight of equipment status from calibration, maintenance, validation, change control, and product changeover, etc.
• Participate in Regulatory inspections and other audits, as required.
• Identify potential compliance issues and opportunities for improvement to the overall Quality Management System. Provide resolution of both technical and compliance issues or gaps.
• Identify and implement process improvements to enhance compliance and improve methods and product quality processes.
• Other duties as assigned.

• Bachelor’s degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management.
• Non‑degreed candidates with 10+ years of combined relevant GLP/GMP quality systems experience will be considered.
• Thorough knowledge of applicable GLP / GMP regulations, ICH & FDA guidelines, and other applicable regulatory guidance (US and EU).
• Familiarity with global cGMP and ISO regulations relating to veterinary medicinal products is a plus.
• Understanding of quality concepts/requirements and ability to practice and implement them, as well as GMP manufacturing processes.
• Experience creating / reviewing / approving documentation such as standard operating procedures (SOPs), work instructions, batch records, protocols, etc.
• Experience with performing audits and participating in audits to include regulatory agency inspections.
• Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged…