AbbVie
Overview
Join to apply for the
Director, Clinical Process Compliance
role at
AbbVie . This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$156,000.00/yr - $296,500.00/yr 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
Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships and a proactive, balanced, and innovative compliance approach. Demonstrates excellence in people leadership and development, and working in a matrixed environment. Onsite Requirements
This role requires onsite work at AbbVie locations. The expected onsite days are Tuesday, Wednesday, and Thursday each week. Locations include Illinois (North Chicago), Massachusetts (Worcester), New Jersey (Branchburg, Florham Park), California (Irvine, South San Francisco). Responsibilities
Identify and lead a high-performing team of GCP Compliance experts to position the organization for successful clinical trial execution outcomes. Partner with Development Leaders to align on strategy for delivery of GCP Compliance and quality principles to meet immediate and evolving business needs and regulatory expectations. Instill a culture of Inspection Readiness across the Development organization with a pro-active and balanced compliance approach. Develop strategy and operational approach for inspection preparation, conduct, and close activities including review of regulatory responses. Ensure tracking and implementation of commitments from inspections and appropriate compliance/inspection support of Clinical Operation functions. Oversee establishment, maintenance, and monitoring of compliance metrics in support of Senior Leader Review and Quality Management Review; interpret and escalate signals, risks, and trends affecting clinical trial outcomes. Inform Senior Leaders regarding health of clinical trial execution during crisis, escalate business-critical decisions, and lead resolution and mitigation as applicable. Represent Development in compliance and quality-related committees and initiatives; share information and best practices with Compliance and Quality Leaders across R&D. Manage the Compliance resource model, identifying risks and potential efficiencies to meet business needs and budget expectations. Direct reports and oversight of external resources as applicable. Qualifications
Bachelor’s degree (or ex-US equivalent) required; advanced degree preferred. 10+ years of pharmaceutical, healthcare, or clinical research experience; Compliance or Quality experience in a highly regulated industry preferred. 5+ years of people leadership experience or demonstrated leadership in a global, matrixed environment. Strong leadership, cross-functional collaboration, and ability to translate vision into operational strategy and execution. Subject Matter Expert in AbbVie\'s Quality Manual principles, standard procedures, and GCP-related regulations. Seniorities & Employment
Seniority level: Director Employment type: Full-time Job function: Legal Industries: Pharmaceutical Manufacturing and Biotechnology Research Additional Information
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
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Join to apply for the
Director, Clinical Process Compliance
role at
AbbVie . This range is provided by AbbVie. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$156,000.00/yr - $296,500.00/yr 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
Drives vision, strategic oversight, and operational delivery of GCP compliance and quality principles related to clinical trial execution. Ensures clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes. Accountable for the end-to-end Clinical Trial Business Continuity process and escalation of business-critical decisions to Senior Leadership across R&D during times of crisis. Instills an Inspection Readiness culture enabling everyday compliance in support of successful inspection outcomes and on-time product approvals. Accelerates patient impact by delivering operational excellence to meet evolving business needs through collaborative partnerships and a proactive, balanced, and innovative compliance approach. Demonstrates excellence in people leadership and development, and working in a matrixed environment. Onsite Requirements
This role requires onsite work at AbbVie locations. The expected onsite days are Tuesday, Wednesday, and Thursday each week. Locations include Illinois (North Chicago), Massachusetts (Worcester), New Jersey (Branchburg, Florham Park), California (Irvine, South San Francisco). Responsibilities
Identify and lead a high-performing team of GCP Compliance experts to position the organization for successful clinical trial execution outcomes. Partner with Development Leaders to align on strategy for delivery of GCP Compliance and quality principles to meet immediate and evolving business needs and regulatory expectations. Instill a culture of Inspection Readiness across the Development organization with a pro-active and balanced compliance approach. Develop strategy and operational approach for inspection preparation, conduct, and close activities including review of regulatory responses. Ensure tracking and implementation of commitments from inspections and appropriate compliance/inspection support of Clinical Operation functions. Oversee establishment, maintenance, and monitoring of compliance metrics in support of Senior Leader Review and Quality Management Review; interpret and escalate signals, risks, and trends affecting clinical trial outcomes. Inform Senior Leaders regarding health of clinical trial execution during crisis, escalate business-critical decisions, and lead resolution and mitigation as applicable. Represent Development in compliance and quality-related committees and initiatives; share information and best practices with Compliance and Quality Leaders across R&D. Manage the Compliance resource model, identifying risks and potential efficiencies to meet business needs and budget expectations. Direct reports and oversight of external resources as applicable. Qualifications
Bachelor’s degree (or ex-US equivalent) required; advanced degree preferred. 10+ years of pharmaceutical, healthcare, or clinical research experience; Compliance or Quality experience in a highly regulated industry preferred. 5+ years of people leadership experience or demonstrated leadership in a global, matrixed environment. Strong leadership, cross-functional collaboration, and ability to translate vision into operational strategy and execution. Subject Matter Expert in AbbVie\'s Quality Manual principles, standard procedures, and GCP-related regulations. Seniorities & Employment
Seniority level: Director Employment type: Full-time Job function: Legal Industries: Pharmaceutical Manufacturing and Biotechnology Research Additional Information
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
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