Site Compliance Manager

BioSpace; Waco (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

Paid time off

401(k) participation

Job summary

A prominent biopharmaceutical company is seeking a Site Compliance Manager to oversee Quality Engineers and ensure compliance with FDA regulations. This role involves managing project support, conducting investigations, and overseeing internal and supplier audits. The ideal candidate will have a scientific bachelor's degree and significant experience in regulatory environments. The company offers a comprehensive benefits package, including medical insurance and a 401(k).

Qualifications

• 7-8 years of related experience in a regulated industry.
• Supervisory experience preferred but not required.
• Familiarity with FDA regulations and international complaints.

Responsibilities

• Manage Quality Engineers and Quality Trainers.
• Conduct CAPA and Non-Conformance investigations.
• Oversee supplier quality compliance and audits.

Skills

Knowledge of applicable regulations

Ability to communicate and collaborate

Ability to function in a cGMPs controlled environment

Education

Bachelor's degree (scientific preferred)

Tools

TrackWise

eLMS

Job description

Site Compliance Manager – BioSpace

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Company Description

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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 AbbVie 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.

Responsibilities

• 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 AbbVie 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.

Qualifications

• 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 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.

Benefits

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 compensation paid within this range will depend on many factors including geographic location and may ultimately be higher or lower than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs and long-term incentive programs.

Equal Opportunity Employer

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Legal

Industries

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