Loading...
SeniorFull-time
Salary Range
$66,300 - $89,700 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
The Compliance Manager is responsible for managing and coordinating project and departmental support with a focus on compliance with FDA regulations and other applicable regulatory bodies. This role plays a key part in maintaining quality system documentation and supporting product field actions.
Key Responsibilities
- →Responsible for Quality System and Compliance investigations and support for processing of complaint/adverse event files following global complaint handling regulations
- →Conduct, review and approve CAPA and Non-Conformance investigations
- →Oversees development of departmental metrics for AbbVie’s local and segment management reviews
- →Oversees supplier quality compliance to support complaint handling in accordance with AbbVie policies
- →Assess opportunities for interdepartmental and site harmonization of practices
- →Review and approve documents pertaining to department Quality Systems
- →Provide generalized Quality System, company, departmental and product knowledge as required
- →Collect data and analyze as required to support inquiries from Regulatory bodies
- →Monitor department processes and workflow compliance to regulatory and department procedures
- →Responsible for Regulatory audit preparation and execution
Requirements
- ✓Experience in compliance management within the pharmaceutical or medical device industry
- ✓Strong knowledge of FDA regulations, 21 CFR 803, 21 CFR 4, CMDR SOR/98-282, ISO 13485:2016, European Union Medical Device Regulation
- ✓Experience with CAPA and Non-Conformance programs
- ✓Ability to analyze processes and make decisions for reportability
- ✓Experience with internal, supplier, and regulatory audits
- ✓Strong organizational and leadership skills
Free to sign up. Takes 30 seconds.
