Senior Quality Assurance Manager

3 days ago

San Francisco, California, United States EPM Scientific Full time
Job Title: Senior Quality Assurance Manager

Join EPM Scientific, a pioneer in the cGMP production sector, as a Senior Quality Assurance Manager. Our company is committed to developing gene therapy and creating novel, secure, and efficient long-term treatments for illnesses.

Key Responsibilities:
  • Support internal Quality Assurance functions focused on GMP manufacturing operations and associated Quality systems.
  • Collaborate with the training team to ensure manufacturing colleagues are operating in compliance with Quality systems.
  • Execute Quality systems to support CDMO manufacturing and lot release, GxP auditing, and training.
  • Provide quality support for external and internal AAV and Plasmid manufacturing and clinical product distribution.
Qualifications:
  • Working knowledge of team function within the organization.
  • Excellent detailed knowledge of cGMP, GLP, FDA guidelines.
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change.
  • Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting.
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment.
  • Must possess a client-focused mindset in daily tasks.
Benefits:
  • The opportunity to work alongside experts who have over 10 years in the gene therapy field.
  • Competitive compensation.
  • Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid.
  • 160 hours of Paid Time Off annually.
  • 11 Company Paid Holidays plus 2 floating holidays annually.
  • Company Paid Life Insurance.
  • 401(k) Match.
  • Company Paid short and long-term disability.
  • 4 weeks of Paid Parental Leave for birth and adoption.
  • Adoption Assistance.
  • Tuition Reimbursement and Student Loan Repayment Assistance.
  • Company Paid LinkedIn Learning access.
  • Employee Assistance Programs.
  • Flexible work options (role specific).

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