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
The Senior Manager of Quality Assurance (QA) is accountable for overseeing the GMP cloning operations and Supplier Management Program to be conducted in the eGenesis. 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 the facilities located in Northwest, Indiana and the Greater Madison Area in Wisconsin. This role will be responsible for ensuring compliance to GMP standards of vendors that are part of Supplier Management Program at eGenesis. This position reports to the Sr. Director 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 role with 2-3 days onsite in our Cambridge, MA office and will require travel to supplier sites.
OPERATIONS RESPONSIBILITIES
- Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of cloning material 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 new facility.
- Supporting day-to-day QA activities associated with manufacturing of cloning materials.
- 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.
SUPPLIER QUALITY MANAGEMENT RESPONSIBILITIES
- Managing the Supplier Quality Management Program at eGenesis.
- Coordinating qualification activities for new vendors and annual audit schedule.
- Overseeing suppliers of raw materials, reagents, equipment, and services supporting the operations at eGenesis.
- Working with key stakeholders for the selection, qualification, and management of suppliers.
- Facilitating risk assessments for new materials or services to be introduced in support of eGenesis’ operations.
- Negotiating and maintaining Quality Agreements between eGenesis and its suppliers.
- Supporting CMC regulatory submissions, as needed.
- Defining, monitoring, and reporting quality performance metrics associated with SQM.
- Ensuring suppliers readiness for regulatory inspections and/or 3rd party audits.
- Participating in on-site audits and regulatory inspections, as needed.
- Managing the Supplier Change Notification (SCN) process and deviations, change controls, and complaints related to the product or services provided by approved suppliers.
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.
- Experience providing QA oversight to manufacturing operations in a pharmaceutical/biotechnology environment.
- 5+ years or supplier/vendor quality management experience in a GxP regulated environment.
- Ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures.
- Ability to negotiate and implement Quality Agreements with vendors.
- 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.
- 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.
