COMPANY MISSION
eGenesis is dedicated to giving patients with organ failure a second chance at life by harnessing the power of genome engineering to create safe, effective, and readily available solutions.
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
