COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
eGenesis is seeking an experienced Associate Director, Quality Assurance Validation (QAV) to lead validation activities supporting our GMP cloning operations and cutting-edge clinical programs, including Phase 1 development. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the operations to maintain all three facilities located in Cambridge, MA, Northwest Indiana and the Greater Madison Wisconsin Area. The ideal candidate will drive the validation strategy, collaborate cross-functionally, and ensure that all systems are in place to support the ongoing development of our gene-editing technologies.
This position reports to the Head of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization. This position will be a hybrid position in Cambridge, MA.
PRIMARY RESPONSIBILITIES
- Lead validation efforts for equipment, facilities, utilities, and processes supporting clinical development programs
- Support the development of policies, processes, procedures, site validation plans and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements (FDA, EU, ICH) and guidelines
- Oversee the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/ maintenance for all facilities
- Evaluate and approve 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
- Support investigations associated with critical or major manufacturing deviations and provide the necessary guidance to authorize manufacturing operations, as applicable
- Support continuous improvement initiatives by identifying and addressing validation gaps
- Oversee and coordinate the execution of validation protocols with external vendors and contract organizations
- Establish and track KPIs for validation activities to ensure efficiency and compliance
- Ensure all equipment, processes, and systems maintain a validated state through periodic reviews and requalification activities
- Review and approve documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facility, as applicable
TECHNICAL QUALIFICATIONS
- B.S./M.S. in Life Sciences or related field with 8+ years of experience, including leadership, in GMP Quality Assurance
- Experience with QA and GMP compliance in clinical biologics products
- 5+ years of experience in quality validation roles within biopharmaceutical manufacturing
- Proven experience with clinical-stage biopharma companies, particularly in Phase 1
- Experience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulations
- Ability to organize and prioritize workload to meet deadlines and company objectives
- Ability to work independently and within cross-functional teams
- Strong knowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics
LEADERSHIP QUALIFICATIONS
- Organizational, staff mentorship, and time management skills with attention to detail
- Ability to negotiate, influence, and work in a cross-functional 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 verbal communication skills with the ability to communicate effectively
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