Remotely
quality assurancepharmaceuticalsregulatoryauditsgmp
Job Description
📋 Description
- Maintain primary quality lead for project activities to achieve on-time quality deliverables
- Drive quality and compliance for product transfers and org optimization
- Develop global Product Quality Assurance strategy for pharma, biologics, devices
- Perform final quality release of lots from Third Party Manufacturers
- Advise on quality, compliance and regulatory conformance; manage high-risk issues
- Communicate with third-party manufacturers and AbbVie sites to align quality and responsibilities
🎯 Requirements
- Bachelor’s in Life Science, Engineering, or technical discipline
- 8+ years total; 3+ in QA Operations Management; 5+ in ops/R&D/regulatory/consulting
- Experience with FDA regulatory interactions and inspections
- Knowledge of pharma/biotech tech (sterile, devices, APIs)
- Familiarity with third-party external manufacturing
- Strong problem-solving, leadership and communication skills
🎁 Benefits
- Comprehensive benefits including PTO, medical/dental/vision, and 401(k)
- Eligible to participate in long-term incentive programs
- Equal Opportunity Employer