Quality Assurance Manager

About the position: The GreenLight 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 manufacture of crop protection products (CPPs) and for 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 (i.e., batch records, QC data, validation protocols, etc.) at GreenLight Biosciences 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).

Key Position Responsibilities

· 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.

Position Requirements

· Bachelor’s degree in scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management.

o 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).

o Familiarity with global cGMP and ISO regulations relating to veterinary medicinal products is a plus

· Understanding of Quality concepts/requirements and be able 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 environment.

· Self-motivated, strong work ethic, organizational skills, communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.

· Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.

· Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.

· Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).

Salary Range: $95,000-$125,000