Site Compliance Manager

About This Role

Manage and coordinate project and departmental support with a focus on FDA compliance and other applicable regulatory bodies and AbbVie requirements for product surveillance and quality systems. This includes overseeing CAPA programs, internal audits, and regulatory audit preparations.

Responsibilities

• Manage and coordinate project and departmental support with a focus on FDA compliance and other applicable Regulatory bodies and AbbVie requirements
• Participate in maintaining quality system documentation including Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs
• Provide necessary support for product field actions
• Responsible for Product Surveillance local management review and participates in quality system management review
• Oversee Global Product Surveillance CAPA program and is responsible for the site’s internal audits
• Oversee internal, supplier and regulatory audits and preparation activities
• Conduct, review and approve CAPA and Non-Conformities investigations
• Oversee development of departmental metrics for AbbVie’s local and segment management reviews
• Review and Approve documents pertaining to department Quality Systems (SOPs, DOPs, forms, etc.)
• Monitor department processes and workflow compliance to regulatory and department procedures and policies and for opportunities for improvement and optimization

Requirements

• 7-8 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 21 CFR 803, 21 CFR 820, 21 CFR 821, 21 CFR 4, EU Medical Device Regulation, CMDR SOR/98-282, ISO 13485:2016
• Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities

Qualifications

• Bachelor’s degree (scientific degree preferred) or High School/GED
• 7-8 years related experience and/or training in a regulated industry (Pharmaceutical, Medical Device, Nuclear) or in a medical environment.

Nice to Have

• Supervisory experienced preferred
• Experience In TrackWise And ELMS

Skills

* Required skills