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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting quality system audits and ensuring compliance with global regulatory requirements in the pharmaceutical and medical device industries. Proficient in GxP regulations, audit management, and cross-functional leadership.
Highest-signal resume keywords
Quality System AuditsGxP RegulationsRegulatory ComplianceLeadership CompetenciesPharmaceutical Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Assurance AuditingRegulatory StandardsAudit ObservationsCorrective ActionsSupplier ManagementTechnical CapabilitiesCompliance AuditingPharmaceutical ManufacturingBiologics RegulationsInternational GMP Standards
Soft Skills
Cross-Functional LeadershipMentoringCollaborationProblem SolvingTraining and Guidance
Certifications & Qualifications
ASQ Certified Quality ManagerCertified Quality Auditor
Industry Keywords
Pharmaceutical ProductsMedical DevicesBiologicsCombination ProductsCosmeticsEye CareAestheticsUS FDAEU RegulationsMDR/IVDR
About the role
Key responsibilities & impact- Carry out comprehensive quality system audits of third-party service providers and manufacturers for compliance with global regulatory requirements
- Interpret, explain, and apply regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
- Independently plan and conduct external supplier audits assessing systems, facilities, and processes
- Provide audit observations and review corrective actions for implementation, effectiveness, and maintenance
- Assist in maintaining the approved supplier list and global audit schedule
- Participate in supplier management processes, including Management Review and Supplier Change Notifications
- Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners
- Collaborate with Inspection Management on external audits by regulatory agencies and customers
- Develop, maintain, and update departmental systems, procedures, and records
- Escalate issues to management as necessary
- Lead cross-functional goals and resolve project team issues with minimal oversight
- Participate in strategic initiatives to improve regulatory compliance
- Coordinate and conduct joint audits with AbbVie Operations
- Ensure audits follow the annual audit schedule
- Mentor others and serve as an effective cross-functional team leader
- Report to the Director RDQA External Partners Quality Audit or designee
Requirements
What you’ll need- Bachelor’s degree preferably in a technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering)
- Demonstrated strong leadership competencies
- Proficient level of technical capabilities and independence
- Proven track record utilizing core and technical competencies
- 8+ years’ total experience, including 3+ years in a compliance or auditing role
- Exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics-related industries
- Thorough understanding of international GMP and device regulatory standards, including US FDA, EU, and MDR/IVDR
- Quality Assurance auditing experience preferred
- Pharmaceutical/device manufacturing experience preferred
- Equivalent combination of education and experience may be accepted as a substitute
- Accreditation by a professional body is desirable, such as ASQ Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA)
Benefits
Comp & perks- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community