Site Compliance Manager
- 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 AbbVies 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.
- Bachelors 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 experienced 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 TrackWise 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.
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
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