AbbVie · 9 hours ago
Site Compliance Manager
Waco, TX
Full-time
Onsite
Senior Level
$106K/yr - $202K/yr
7+ years expAbbVie is dedicated to discovering and delivering innovative medicines that address serious health issues. The Site Compliance Manager will oversee a team of Quality Engineers and Trainers, ensuring compliance with FDA regulations and managing quality system documentation while supporting product surveillance efforts.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations, device tracking, clinical protocol data intake and internal procedures. Ability to analyze current processes and information obtained and make decisions for reportability under 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation and applicable international vigilance regulations
Conduct, review and approve CAPA and Non-Conformance investigations. Monitor and support Quality Engineers approving investigations. Responsible for CAPA and Non-Conformance program for Global Product Surveillance
Oversees development of departmental metrics for AbbVie’s local and segment management reviews and ad hoc requests
Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies
Assess opportunities for interdepartmental and site harmonization of practices and interruption of quality system requirements
Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.)
Provide generalized Quality System, company, departmental and product knowledge as required
Collect data and analyze as required to support inquiries from Regulatory bodies, internal and external customers
Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization
Responsible for Regulatory audit preparation and execution. Host audits on site and travel to other sites to support audits and inspections as needed. Maintain internal audits schedule and organize audits to self-identify compliance non-conformities. Provide leadership and design for back room audit support activities and document reviews
Qualification
Required
Bachelor's degree (scientific degree preferred) and seven to eight years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear, etc..) or in a medical environment
Knowledge of applicable regulations including, but not limited to, 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and other international complaint handling and vigilance regulations
Ability to communicate and collaborate with other departments such as the Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, and Marketing departments to ensure corporate goals and strategies are met
Ability to initiate or suggest plans to motivate workers to achieve work goals
Ability to provide accurate and complete information in a prompt manner
Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
Preferred
Supervisory experienced preferred but not required
Experience in TrackWise and eLMS preferred
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs
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
2025-12-31
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