Sr. Manager/Associate Director Quality Assurance
Expiry Date :
Mon, 14 Jun 2021 23:59:59 GMT
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Generation Bio is an innovative genetic medicines company focused on creating a new class of non-viral gene therapy to provide durable, redosable treatments for people living with rare and prevalent diseases. The companys non-viral platform incorporates a proprietary, high-capacity DNA construct called closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle delivery system, or ctLNP; and an established, scalable capsid-free manufacturing process. The platform is designed to enable multi-year durability from a single dose of ceDNA and to allow titration and redosing if needed, and our scalable manufacturing process supports our mission to extend the reach of gene therapy to more people, living with more diseases, in more places around the world. Our vision is to make the ravages of genetic disease as imaginary to the next generation as polio feels to children today.
We are a thriving, collaborative, creative community of 120 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.
Delve further. Please visit [ follow @generationbio [
Generation Bio is seeking an energetic and highly motivated Senior Manager/Associate Director of Quality Assurance who will be responsible for developing corporate quality systems, supportive policies and procedures that enable Generation Bio to comply with GxP regulatory requirements and evolving regulatory expectations, while also helping build a Quality Culture internal to the company. This role will directly be responsible for ensuring that Generation Bios Quality systems enable and facilitate compliance across all GxP areas of the company: GLP, GMP, GCP, GVP. Systems will be established and scaled to support Generation Bios pipeline needs, in a phase-appropriate manner (pre-clinical through commercial). Quality Systems within the scope of this role include, but are not limited to, disposition, deviation, corrective/preventive action (CAPA) and change control.
* Establish and maintain the disposition quality process.
* Establish and maintain deviation, CAPA and change control processes, including implementation and improvement of e-system
* Responsible for clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition
* Review and approve deviation reports, CAPAs and change controls. Mentor investigators and approvers on the investigation process and technical writing
* Review and approve root cause analysis and product impact assessments for investigations resulting from deviations and OOS
* Meet quality assurance objectives by contributing information and analysis to strategic plans/reviews
* Interface directly with Generation Bio Leadership to assure cross functional alignment of goals and objectives ensuring GxP compliance and realization systems related best practices.
* Ensure that Generation Bio is inspection ready and serve as the host/co-host of regulatory inspections.
* Lead, manage, and develop a support staff of quality professionals
* Support and foster an environment conducive to innovation, high productivity, and high quality
* Bachelors degree or higher in Life Sciences/Chemistry, or engineering with 10+ years of experience in the pharmaceutical/ biotech industry, at least 5 years in a Quality Assurance role
* Must have CMO experience executing and managing GMP disposition, deviation, investigation and change controls
* Strong knowledge of cGMPs, FDA, EU GxP, ICH regulations.
* Strong technology aptitude, with hands on experience in E-Systems (e.g Veeva)
* Strong verbal and written communication skills, detail-oriented, exceptionally organized, and possesses the ability to influence change across different stakeholder groups (internal and external)
* Direct experience with regulatory health authority interactions
* Must be a proven problem-solver, able to operate as both an individual contributor and a people manager to deliver on key objectives, flexing based on the business needs
* Experience managing direct reports
* Must be collaborative and outwardly focused
POSITION: Full-Time, Exempt
EEOC Statement: Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.