Quality Assurance Manager

4 days ago


Chicago, Illinois, United States BioSpace, Inc. Full time
Job Title: Quality Assurance Manager

At BioSpace, Inc., we are seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for directing, implementing, and providing consultation for external manufacturing/packaging worldwide to ensure compliance with global regulatory requirements.

Key Responsibilities:
  • Manage GxP quality/inspection activities to ensure compliance with quality systems, manufacturing facilities, testing programs, clinical and pre-clinical study conduct, personnel, and records.
  • Influence and train inspection preparation teams comprised of technical experts.
  • Coordinate GxP pre-approval inspection preparation activities for contract facilities utilized in support of regulatory filings.
  • Strategize corrective action plans and provide compliance support during implementation to ensure GMP compliance and successful inspections.
  • Effectively communicate risks to management, both orally and in writing.
Qualifications:
  • Bachelor's degree in physical science, life science, or pharmacy.
  • Strong technical background and ability to communicate, understand, and direct individuals in highly specialized technical fields.
  • Accreditation by a professional body, such as ASQ Certified Quality Manager or Project Management Professional.
  • Management experience, managing 1 or more Quality Specialists.
  • Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory, or Validation background in a regulated industry.

We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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