Senior Manager, External Partners Oversight
AbbVie
September 02, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Purpose:
Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of external suppliers that provide materials and services to AbbVie.
Provides leadership, direction, and execution in compliance and quality; assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements to assure quality, effectiveness and safety of medical device, clinical materials, and drug development suppliers.
Responsibilities:
- Assess compliance with applicable regulations through supplier oversight activities (early detection/prevention; correction of issues).
- Interpret, explain, and apply applicable governmental regulations, guidelines, policies, and procedures.
- Manage Quality Agreement life cycle (create, periodic cross-functional review evaluations, withdraw/terminate as applicable).
- Serve as an expert in GxP requirements within R&D.
- Collaborate with R&D and assist in resolution of external supplier quality issues.
- Prioritize activities to meet study/program objectives; maintain project oversight and timeliness awareness.
- Lead or participate in technically complex, strategic cross-functional projects.
- Lead or participate in compliance improvement initiatives.
- Maintain independence, objectivity, and appropriate involvement.
- Collect, analyze, and report External Partners Quality metrics.
- Demonstrate Ways of Working and Leadership Attributes; foster a learning environment and manage innovation.
Qualifications:
- Bachelor’s in a technical/scientific area (Chemistry, Pharmacy, Biology, Microbiology, Engineering) or equivalent experience (8+ years) with medical device or combination product exposure.
- Thorough understanding of international regulatory standards; GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations preferred.
- Technical background; thorough understanding of supplier oversight.
- Knowledge of quality/operational systems for study/product design and device development; quality management principles.
- Excellent oral/written and interpersonal skills; leadership, tact, maturity, tenacity, decisiveness, self-reliance, organizational/admin skills, sound judgment.
- Effective communication across RDQA functions, technical areas, and external parties.
- 8+ years in QA/Regulatory Affairs or related fields; compliance/auditing (preferred) and/or laboratory experience (preferred).
- Professional accreditation desirable (e.g., ASQ CQM/CQA).
Primarily responsible for providing leadership and direction and performing evaluations for compliance with worldwide regulatory requirements; providing relevant and constructive evaluation of external suppliers that provide materials and services to AbbVie.
Provides leadership, direction, and execution in compliance and quality; assures that activities are performed and documented in accordance with applicable worldwide quality and regulatory requirements to assure quality, effectiveness and safety of medical device, clinical materials, and drug development suppliers.
Responsibilities:
- Assess compliance with applicable regulations through supplier oversight activities (early detection/prevention; correction of issues).
- Interpret, explain, and apply applicable governmental regulations, guidelines, policies, and procedures.
- Manage Quality Agreement life cycle (create, periodic cross-functional review evaluations, withdraw/terminate as applicable).
- Serve as an expert in GxP requirements within R&D.
- Collaborate with R&D and assist in resolution of external supplier quality issues.
- Prioritize activities to meet study/program objectives; maintain project oversight and timeliness awareness.
- Lead or participate in technically complex, strategic cross-functional projects.
- Lead or participate in compliance improvement initiatives.
- Maintain independence, objectivity, and appropriate involvement.
- Collect, analyze, and report External Partners Quality metrics.
- Demonstrate Ways of Working and Leadership Attributes; foster a learning environment and manage innovation.
Qualifications:
- Bachelor’s in a technical/scientific area (Chemistry, Pharmacy, Biology, Microbiology, Engineering) or equivalent experience (8+ years) with medical device or combination product exposure.
- Thorough understanding of international regulatory standards; GxP (GMP, GLP, GCP, GDP, GCLP) and Medical Device regulations preferred.
- Technical background; thorough understanding of supplier oversight.
- Knowledge of quality/operational systems for study/product design and device development; quality management principles.
- Excellent oral/written and interpersonal skills; leadership, tact, maturity, tenacity, decisiveness, self-reliance, organizational/admin skills, sound judgment.
- Effective communication across RDQA functions, technical areas, and external parties.
- 8+ years in QA/Regulatory Affairs or related fields; compliance/auditing (preferred) and/or laboratory experience (preferred).
- Professional accreditation desirable (e.g., ASQ CQM/CQA).