GLP Quality Assurance Manager
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Employment type:
Full time
Experience required:
Intermediate
Salary
Salary not provided
About the company:
ABOUT GREENLIGHT
At GreenLight we are working to solve two of the world's greatest problems: global food insecurity and equal access to vaccines and the associated health benefits. Unlike most corporations who can be required to put profits ahead of other principles, GreenLight is one of the first Public Benefit Corporations to be publicly traded and have a charter that requires a focus on how it benefits its employees, community and society and has a broad portfolio addressing key issues in plant health and human health (Nasdaq: GRNA) by leveraging the full potential of dsRNA and mRNA. The GreenLight team is a little over 260 people across our headquarters in Lexington, MA, an R&D facility and an R&D facility in Research Triangle Park, NC. GreenLight also has a biomanufacturing plant in Rochester, NY. Initiatives include finding ways to support biodiversity, protect bees and other pollinators, treat rare diseases as well as develop vaccines.
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 www.greenlightbio.com.
About the position: The GreenLight team is looking for a high-performing, middle management, self-motivated individual who works well in a fast-paced environment in a leading-edge biotech company. The company is looking for a key individual to play a pivotal role in advancing breakthrough biobased products. Reporting to the Director of Regulatory Sciences, the individual will be a key contributing member of our Plant Health team. The position will establish and run a GLP compliant quality organization supporting the advancement of RNA based products for Agriculture. The Ideal candidate would be able to effectively build quality systems capable of meeting GLP standards as well as regulatory agency scrutiny.
Job Requirements:
- This role will provide leadership Quality Assurance for the newly established GLP function of GreenLight Bioscience’s Plant Health division in Durham, NC.
- The incumbent will develop, implement, and manage quality systems used to support global regulatory submission of RNA-based products consistent with GLP regulations such as 40 CFR 160.
- This position is responsible for monitoring GLP studies to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with said regulations.
- Represent Greenlight Bioscience GLP-QA function during audits by regulatory bodies.
- Review and approval of third party generated GLP studies, to include on-site auditing of third-party systems.
- Ensure compatibility with existing Quality systems employed at Greenlight’s manufacturing facility in Rochester, NY.
- Maintenance of the Master Schedule and Oversight of GLP archive systems.
- Review and approve quality system documents.
- Will coordinate activities with QA peers in the Life Sciences program when using or implementing shared resources or for mutual program support activities such as conducting internal audits.
Qualifications:
- Advanced degree in a scientific or operational discipline relevant to the Biotechnology Manufacturing.
- 10+ years of quality assurance experience in a GLP or GMP regulated environment Experience in development and registration of agricultural products is highly preferred.
- Proven leadership specifying, implementing, and maintaining GLP or GMP systems.
- Highly detail oriented with a demonstrated compliance mindset.
- Demonstrated ability to analyze, extrapolate data, hypothesize, plan, communicate and implement in a collaborative and engaged environment.
- Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges.
- Ability to effectively communicate to internal and external stakeholders.
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.
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