Forge Biologics

Forge Biologics

Compliance Specialist Lead

Columbus, Ohio · Senior

Sponsorship not specifiedDetected 3 days ago
ComplianceProduct ManagementAuditingGMPCommunicationProblem SolvingMentoringInternal Audit

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About the role

  • We are currently seeking a Compliance Specialist Lead, to join the Forge Biologics team.
  • This person will support improvement initiatives related to the Quality Management Review (QMR), and support External Audit program, and processes to ensure Forge's compliance with the appropriate regulatory agency requirements, internal company standards, client requirements, and current Good Manufacturing Practices (cGMPs).

Responsibilities

  • Support Regulatory Compliance/Quality Representatives and apply regulatory knowledge and judgment to identify potential compliance concerns and identify potential remediation action.
  • Support and update Site Governance and Standard Operating Procedures, Training and content/delivery. Promote audit/ inspection ready culture.
  • This position will drive both the strategy and the delivery for Regulatory and Quality Compliance Initiatives, and this individual also oversees the GMP Internal Audit program.

Requirements

  • Experience interacting with domestic and international regulatory agencies.
  • Working knowledge of quality systems and ability to apply GMP's in conformance to U.S. and Global standards, and where appropriate, other regulatory authority standards.
  • Bachelor's degree in related discipline with 5+ years of compliance experience in a regulated industry (i.e., regulatory compliance experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment).
  • Excellent analytical, communication, and problem solving skills
  • Proven ability to manage multiple prior in a fast- paced environment.
  • Partner with internal departments (e.g. Manufacturing, Quality, Facilities and Engineering) to ensure end-to-end compliance throughout the product lifecycle and commercial readiness.
  • Exemplifies good quality and compliance practices while championing Quality Culture throughout the organization.

Nice to have

  • Preferred Skills:

Skills

  • American Society for Quality
  • CQA or equivalent certification
  • American Society for Quality - CQA or equivalent certification
  • Your Future with Us:
  • to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • At Forge, your growth matters.

Benefits

  • Support the coordination of Management Review includes monitoring the overall health of the Quality system through evaluation of KPIs, effectiveness checks, and risk management.

Company info

  • Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities.
  • Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • Here, you won't just watch innovation happen - you'll be part of it.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.