Site Compliance Manager
AbbVie
3 months ago
On-site
Waco, TX
$106,500 - $202,500 USD yearly
Operations
Purpose
The Compliance Manager is responsible for managing and coordinating project and departmental support focused on compliance activities with FDA requirements, other applicable regulatory bodies, and AbbVie requirements. Maintains quality system documentation (Quality Manuals, AMED Standards, Global Quality Policies, departmental SOPs), supports product field actions, oversees Product Surveillance local management review and quality system management review, leads Global Product Surveillance CAPA, and is responsible for the site’s internal audits. Oversees internal, supplier, and regulatory audits and preparation.
Responsibilities
- Lead Quality System and Compliance investigations, including processing complaint/adverse event files per global complaint handling regulations; device tracking; clinical protocol data intake; and internal procedures. Determine reportability under applicable regulations (e.g., 21 CFR 803/4, ISO 13485:2016, EU Medical Device Regulation).
- Conduct, review, and approve CAPA and Non-Conformance investigations; monitor/support Quality Engineers; own CAPA/Non-Conformance program for Global Product Surveillance.
- Develop departmental metrics for local/segment management reviews and ad hoc requests.
- Oversee supplier quality compliance to support complaint handling per AbbVie policies.
- Identify opportunities to harmonize practices and ensure quality system requirements are not interrupted.
- Review and approve departmental Quality System documents (SOPs, DOPs, forms, etc.).
- Collect and analyze data to support inquiries from regulatory bodies and internal/external customers.
- Monitor department workflow compliance and identify improvement/optimization opportunities.
- Prepare for and execute regulatory audits; host audits, travel as needed, maintain internal audit schedules, and lead back-room audit support and document reviews.
Qualifications
- Bachelor’s degree (scientific degree preferred) and 7–8 years’ experience/training in a regulated industry or medical environment. Supervisory experience preferred but not required.
- Knowledge of applicable regulations including 21 CFR 803/820/821/4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and related complaint handling/vigilance regulations.
- TrackWise and eLMS experience preferred.
- Ability to communicate/collaborate with cross-functional teams (e.g., Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, Marketing).
- Ability to initiate/suggest plans to motivate workers and achieve goals.
- Ability to provide accurate and complete information promptly.
- Ability to operate in a cGMP-controlled environment regulated by the FDA and other authorities.
- Ability to apply statistical/probability concepts and quantitative reasoning (fractions, percentages, ratios, proportions).
Benefits
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
- Eligible for short-term and long-term incentive programs.
Application instructions
- None provided in the job description text.
The Compliance Manager is responsible for managing and coordinating project and departmental support focused on compliance activities with FDA requirements, other applicable regulatory bodies, and AbbVie requirements. Maintains quality system documentation (Quality Manuals, AMED Standards, Global Quality Policies, departmental SOPs), supports product field actions, oversees Product Surveillance local management review and quality system management review, leads Global Product Surveillance CAPA, and is responsible for the site’s internal audits. Oversees internal, supplier, and regulatory audits and preparation.
Responsibilities
- Lead Quality System and Compliance investigations, including processing complaint/adverse event files per global complaint handling regulations; device tracking; clinical protocol data intake; and internal procedures. Determine reportability under applicable regulations (e.g., 21 CFR 803/4, ISO 13485:2016, EU Medical Device Regulation).
- Conduct, review, and approve CAPA and Non-Conformance investigations; monitor/support Quality Engineers; own CAPA/Non-Conformance program for Global Product Surveillance.
- Develop departmental metrics for local/segment management reviews and ad hoc requests.
- Oversee supplier quality compliance to support complaint handling per AbbVie policies.
- Identify opportunities to harmonize practices and ensure quality system requirements are not interrupted.
- Review and approve departmental Quality System documents (SOPs, DOPs, forms, etc.).
- Collect and analyze data to support inquiries from regulatory bodies and internal/external customers.
- Monitor department workflow compliance and identify improvement/optimization opportunities.
- Prepare for and execute regulatory audits; host audits, travel as needed, maintain internal audit schedules, and lead back-room audit support and document reviews.
Qualifications
- Bachelor’s degree (scientific degree preferred) and 7–8 years’ experience/training in a regulated industry or medical environment. Supervisory experience preferred but not required.
- Knowledge of applicable regulations including 21 CFR 803/820/821/4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016, and related complaint handling/vigilance regulations.
- TrackWise and eLMS experience preferred.
- Ability to communicate/collaborate with cross-functional teams (e.g., Device Analysis Lab, Quality Assurance, Regulatory Affairs, Clinical Studies, Customer Care, Operations, Marketing).
- Ability to initiate/suggest plans to motivate workers and achieve goals.
- Ability to provide accurate and complete information promptly.
- Ability to operate in a cGMP-controlled environment regulated by the FDA and other authorities.
- Ability to apply statistical/probability concepts and quantitative reasoning (fractions, percentages, ratios, proportions).
Benefits
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) for eligible employees.
- Eligible for short-term and long-term incentive programs.
Application instructions
- None provided in the job description text.