Site Compliance Manager

Site Compliance Manager – Bio Space

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Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose:

Manages Quality Engineers and Quality Trainer engaged in activities to support Product Surveillance for Medical Devices and Combination products. The Global Compliance Manager is responsible for the management and coordination of a team of Quality Engineers and Quality Trainer. Manages project and departmental support with a focus on activities linked to compliance to FDA compliance and other applicable Regulatory bodies and Abb Vie requirements.

Participates in maintaining quality system documentation including but not limited to:
Quality Manuals, AMED Standards, Global Quality Policies, and departmental SOPs. Provides necessary support for product field actions. Responsible for Product Surveillance local management review and participates in quality system management review. Oversees Global Product Surveillance CAPA program and is responsible for the sites internal audits. Oversees internal, supplier and regulatory audits and preparation activities.

• 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 Abb Vie local and segment management reviews and ad hoc requests.
• Oversees supplier quality compliance to support complaint handling in accordance with Abb Vie 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.

• 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. Supervisory experience preferred but not required.
• 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.
• Experience in Track Wise and eLMS preferred.
• 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.

Compensation:
The range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual…