AbbVie · 6 days ago
Senior Manager - RDQA External Partners Oversight (ExPO)
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $230K/yr
8+ years expAbbVie is a company focused on discovering and delivering innovative medicines and solutions to address serious health issues. The Senior Manager - RDQA External Partners Oversight (ExPO) is responsible for providing leadership and direction for compliance evaluations and ensuring adherence to worldwide regulatory requirements in clinical external supplier management.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Assess compliance with applicable regulations through supplier oversight activities. The strategic focus is for early detection and prevention, followed by correction of issues
Interpret, explain, and apply applicable current governmental regulations, guidelines, policies, and procedures as applicable to associated activities
Manage Clinical Quality Agreement life cycle; lead the creation of the Clinical Quality Agreement; lead the conduct of cross-functional periodic review evaluations of Clinical Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Clinical Quality Agreements, as applicable
Provide an active role within R&D as an expert in GCP requirements
Collaborate with R&D functional areas and assist in the resolution of external supplier quality issues
Prioritize activities to ensure objectives of studies/programs are met. Maintain project oversight to include awareness of project timeliness
Lead or participate in technically complex and strategic cross functional projects
Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards
Achieve a difficult balance of involvement, independence, and objectivity
Collect, analyze, and report metrics pertaining to External Partners Quality
Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a collaborative mindset and leadership. Create a learning environment, embrace the ideas of others, and manage innovation to reality
Qualification
Required
Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 8 years) with sufficient exposure to medical device or combination product related industries
Thorough understanding of clinical, e.g. GCP, international regulatory standards
Must have a technical background and a thorough understanding of the supplier oversight
Must understand a variety of quality/operational systems that support study/product design, device development and understand the principles of quality management
Must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational / administrative skills, and sound judgment
Preferred
Understanding of GMP, GLP, GDP, GCLP) and Medical Device regulations and standards optional
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
2026-01-18
2026-01-17
Company data provided by crunchbase