CRISPR Therapeutics Manager/Senior Manager, Quality Operations in Framingham, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
The Manager QA Operations is accountable for leading the team responsible of providing direct QA support to the manufacturing operations at the new CRISPR Therapeutics facility in Framingham, MA. The position will report to the Associate Director QA Operations and will collaborate in the QA oversight in the production of drug products including support of end-to-end operations from technology transfer and clinical production through commercialization .
During the facility completion stage, as part of the Site Quality Team, this position is responsible for:
Hiring and on-boarding QA personnel per recruitment plan to support QA GMP activities.
Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of Gene Editing clinical products.
Supporting development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelines.
Supporting the qualification activities associated with the implementation and release of electronic systems, facility areas (i.e. manufacturing suites), and equipment onboarding/maintenance for the new facility.
Upon completion of facility qualification, this position is responsible for:
Leading day-to-day QA activities associated with manufacturing.
Releasing of manufacturing suites and batch/product changeovers for continuation of manufacturing activities.
Participating in cross-functional teams to resolve Quality related issues impacting manufacturing activities.
Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs.
Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility.
Evaluating and approving proposed process changes and improvements in the Manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelines.
Supporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicable.
Authoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.).
Maintaining the QA Operations function in a state of compliance and Inspection readiness.
Key internal partners include Manufacturing, Quality Control, Analytical Development, Facilities, Supply Chain, IT, and Regulatory Affairs.
B.S./M.S. in Life Sciences or Chemical Engineering with 8+ years of experience, including leadership, in GMP Quality Assurance.
Experience with QA and GMP compliance in clinical and commercial biologics products.
Experience providing QA oversight to manufacturing operations in a pharmaceutical/biotechnology environment.
Knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical and commercial production and supply of biopharmaceutics.
Organizational, staff mentorship, and time management skills with attention to detail.
Ability to negotiate, influence, and work in a matrix environment.
Handling multiple assignments in a fast-paced environment with changing priorities.
Independent development and execution of work plans with minimal supervision.
Strong analytical, problem-solving, and critical-thinking skills.
Excellent written and oral communication skills.
Gene Therapy / Gene Editing drug development, clinical production and commercialization.
Leading QA teams responsible for the oversight of manufacturing activities.
Hosting/participating in Health Agency pre-approval inspections.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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