QC Manager

1 day ago


Lexington, Massachusetts, United States Genezen Full time
Job Title: Quality Control Manager

We are seeking a highly skilled Quality Control Manager to join our team at Genezen. As a Quality Control Manager, you will be responsible for overseeing the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations department.

Key Responsibilities:
  • Maintain a safe, efficient, functional, and compliant cGMP laboratory according to regulatory, site, and corporate guidelines.
  • Oversee day-to-day operations that include cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, cell banks following respective procedures.
  • Support/Review/Approve Instrument Equipment/Instrument validation protocols and reports, as well as routine PM/annual OQ.
  • Ensure all QC equipment/instrumentation is maintained in the validated state and associated logbooks compliant.
  • Management of critical reagents, controls, and laboratory supplies in QC Ops possession.
  • Support method validation and analytical technology transfer activities partnered with QC Technical Services and QA.
  • Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance, and CAPA including.
  • Authors and/or reviews complex documentation such as retest/method/critical reagent protocols and reports, investigations, CMC regulatory sections, and SOPs/Forms.
  • Perform and/or support data and quality metric (KPI) trending as required.
  • Support/author risk assessments as required to support QC Operations.
  • Ensure compliance to with all necessary regulatory guidelines and support internal and external audits.
  • Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency.
  • Represent QC at inter-departmental meetings and liaise with cross-functional departments as needed.
  • Ensure staff are trained to meet capacity and business continuity.
  • Provide coaching and development to directs to meet business and respective career goals.
  • Build strong relations and collaboration with cross-functional teams.
Requirements:
  • A minimum of a Bachelor's degree in Life Sciences or Engineering.
  • Experience and Skill Requirements: 10-15 years of cGMP QC testing experience within Bioanalytical/Bioassay/Virology with minimum of 8 – 10 years of personnel management.
  • Large molecule, gene, or cell therapy technical experience.
  • Cell culture experience (human-derived cell lines) is required.
  • Excellent analytical and problem-solving skills.
  • Thorough understanding of industry and regulatory testing requirements.
  • Must possess excellent communication, organizational, and time management skills.
  • Self-directed with minimal supervision.
  • Ability to work well with diverse groups.
  • Ability to manage multiple activities with challenging timelines.
  • Ability to motivate, mentor, and develop staff.
Benefits:
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Share Appreciation Rights.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
  • Employer-paid basic term life/personal accident insurance.
  • Voluntary disability, universal life/personal accident insurance.
  • Accidental Death & Dismemberment (AD&D) Insurance.
About Genezen:

Genezen is a leading provider of gene therapy solutions. We are committed to delivering high-quality products and services to our clients. Our team is dedicated to innovation, collaboration, and excellence.

We operate two locations: one in Fishers, Indiana, and the second in Lexington, Massachusetts. Both locations offer a unique blend of history, culture, and natural beauty.



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