Description
Manager, Quality Assurance Operations
Team: Quality
Location: Northwest, Indiana
Commitment: Full-Time
Workplace Type: onsite
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
The Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.
This role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization.
PRIMARY RESPONSIBILITIES
- Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of drug product to be used in clinical studies
- Supporting the 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 systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/maintenance for the facility
- Supporting day-to-day QA activities associated with manufacturing of drug product
- Releasing 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 associated with the operations at the manufacturing facility
- 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.)
- Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as needed
- Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
- Maintaining the QA Operations function in a state of compliance and inspection readiness
BASIC QUALIFICATIONS
- B.S./M.S. in Life Sciences or related field with 5+ years of experience, including leadership, in GMP Quality Assurance
- Experience with QA and GMP compliance in clinical biologics products
- Experience providing QA oversight to manufacturing operations in a pharmaceutical/ biotechnology environment
- Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures
- 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
- 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 details
- 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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