Senior Manager, Quality Assurance

2 weeks ago

Madison, Wisconsin, United States eGenesis Full time

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 at eGenesis' facility in Wisconsin. 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 facility in a state of compliance. This candidate will also be responsible for providing quality guidance to the activities being performed at other eGenesis facilities. This position reports to the Vice President of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization.

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.
  • Leading 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.

FACILITIES RESPONSIBILITIES

  • Supporting commissioning activities for the facility/utilities/systems and onboarding of new equipment to be installed in support of GMP operations.
  • Supporting and providing QA oversight for validation of electronic systems to be installed in compliance with applicable regulations (i.e., 21CFR Part 11 and EU GMP Annex 11).
  • Reviewing and approving system validation and infrastructure qualification documents for User Requirements and Functional Requirements specifications, Design Specifications/Qualifications (DQs), Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs).
  • Leading the development and implementation of processes aimed at supporting a compliant, robust and sustainable lifecycle for facilities/utilities/systems/equipment.
  • Author/lead development of controlled documents such as policies, processes, and procedures associated with facilities/utilities/systems/equipment lifecycle processes.
  • Leading the implementation of validation/qualification strategies and serving as Subject Matter Expert.
  • Performing gap analyses on processes, systems, and practices and recommending and implementing corrective actions and improvements including requalification/revalidation exercises.
  • Approving preventive maintenance/calibration, work orders for facilities/ utilities/ systems/ equipment.
  • Leading/supporting deviations, investigations, CAPAs, and Change Controls associated to facilities/utilities/systems/equipment.
  • Ensuring eGenesis' facilities/utilities/systems/equipment processes are maintained in a state of inspection readiness.

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.
  • Experience in development, execution, and approval of DQs, IQs, OQs, and PQs.
  • Working knowledge of environmental and utilities monitoring principles.
  • 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 the compliance requirements for the facilities and equipment lifecycle processes.
  • 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.

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