Quality Systems Manager

3 hours ago

Columbus, Ohio, United States Forge Biologics Full time
About the Role

Forge Biologics is seeking a highly skilled Quality Systems Manager to join our team. As a key member of our quality team, you will be responsible for managing and improving our quality systems to ensure compliance with regulatory requirements.

Key Responsibilities:

  • Manage quality events and continuous improvement of the Quality Systems, including Investigations, Continuous Improvements, CAPAs, Change Controls, and other quality systems implemented at Forge.
  • Facilitate the compiling, trending, and reporting of key quality metrics for management and other quality system functions.
  • Responsible for implementation and compliance to schedule, conduct, and document Management Review, including preparation of the Management Review Agenda and Minutes.
  • Communicate with other technical groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust.
  • Responsible for the authoring or review and approval of controlled documentation, including Standard Operating Procedures (SOPs), Work Instructions, Guidance's, and other controlled document types.
  • Support hosting client/regulatory inspections, inspection readiness training, and reviewing audit reports and responses, as needed.

Requirements:

  • Bachelor's Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering, or related life science field.
  • Quality Systems experience in an FDA regulated field/industry.
  • Experience supporting inspections performed by FDA and/or foreign Regulatory Authorities.
  • Strong understanding of Quality Risk Management practices and procedures.
  • Experience making prompt, scientifically and/or statistically sound, quality/regulatory compliant decisions that have impact on product release.
  • Thorough knowledge of pharmaceutical cGMP requirements, including strong working knowledge of FDA and EU requirements/guidance documents.
  • Prior management experience.
  • Intermediate level skill in Microsoft Word, Excel, Outlook, and other office software programs.
  • Ability to work onsite in Columbus, Ohio 4 days/week on average.

What We Offer:

  • Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents.
  • Flexible PTO (plus 14 paid company holidays).
  • Annual bonus for all full-time employees.
  • 401(K) company match.
  • Fully-stocked kitchen with free food/drinks.
  • 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care.
  • Employee Assistance Program.
  • Wellness benefits (financial planning services, mental health counseling, employer paid disability).
  • Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches.

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