Director - Clinical Process Compliance
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 natural 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.
* This role can be hired globally.
* If a candidate resides within a commutable distance to the North Chicago office, there will be a hybrid onsite expectation.
Effectively identifies and leads high performing team of GCP Compliance experts who position the organization for successful clinical trial execution outcomes including inspection success and on-time product approvals.
Partners 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.
Instills a culture of Inspection Readiness across the Development organization through a pro-active and balanced compliance approach.
Develops the strategy and operational approach for inspection preparation, conduct, and close activities including review of the response submitted to the regulatory agency.
Ensures tracking and implementation of commitments from inspections and appropriate compliance/inspection support of Clinical Operation functions
Oversees the establishment, maintenance, and monitoring of compliance metrics in support of Senior Leader Review and the Quality Management Review process. Accountable for interpretation and escalation of compliance metric signals, risks, and trends that have potential impact on successful clinical trial outcomes.
Informs Senior Leaders regarding health of clinical trial execution during time of crisis including risks to successful clinical trial outcomes and process/regulatory compliance. Escalates business-critical decisions needed to support Business Continuity to Senior Leadership for review, leads resolution, and mitigation efforts as applicable.
Represents Development in compliance and quality-related committees and initiatives including company-wide strategic and industry benchmarking discussions. Connects with Compliance and Quality Leaders across R&D to share relevant information, best practices, and latest compliance-related industry and regulatory intelligence.
Responsible for active management of the Compliance resource model, identifying risks and potential efficiencies to ensure business needs and budgetary expectations are met and aligned with strategic direction.
This position will have direct reports and may have oversight of external resources
Qualifications
Bachelor’s degree (or ex-US equivalent) is required; advanced degree preferred
10+ years of pharmaceutical, healthcare, or clinical research related experience; Compliance or Quality experience within highly regulated industry preferred
5+ years of people leadership experience, or extensive evidence, demonstrating successful leadership in highly dynamic, global, and matrixed environment
Demonstrates excellence in people leadership and development, leading cross-functional teams, and fostering global team productivity and cohesiveness
Able to translate organizational vision and mission into operational strategy, plan, and execution
Considered a Subject Matter Expert and competent in the application of AbbVie's Quality Manual principles, standard business procedures, and GCP-related regulations
Key Stakeholders
Senior Leaders within Clinical Development Operations, Regulatory, Quality Assurance, Pharmacovigilance, Legal, Data & Statistical Sciences, Clinical Drug Supply Management, TAMD program and study teams
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation 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 we may ultimately pay more or less 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.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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
About the job
Apply for this position
Director - Clinical Process Compliance
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 natural 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.
* This role can be hired globally.
* If a candidate resides within a commutable distance to the North Chicago office, there will be a hybrid onsite expectation.
Effectively identifies and leads high performing team of GCP Compliance experts who position the organization for successful clinical trial execution outcomes including inspection success and on-time product approvals.
Partners 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.
Instills a culture of Inspection Readiness across the Development organization through a pro-active and balanced compliance approach.
Develops the strategy and operational approach for inspection preparation, conduct, and close activities including review of the response submitted to the regulatory agency.
Ensures tracking and implementation of commitments from inspections and appropriate compliance/inspection support of Clinical Operation functions
Oversees the establishment, maintenance, and monitoring of compliance metrics in support of Senior Leader Review and the Quality Management Review process. Accountable for interpretation and escalation of compliance metric signals, risks, and trends that have potential impact on successful clinical trial outcomes.
Informs Senior Leaders regarding health of clinical trial execution during time of crisis including risks to successful clinical trial outcomes and process/regulatory compliance. Escalates business-critical decisions needed to support Business Continuity to Senior Leadership for review, leads resolution, and mitigation efforts as applicable.
Represents Development in compliance and quality-related committees and initiatives including company-wide strategic and industry benchmarking discussions. Connects with Compliance and Quality Leaders across R&D to share relevant information, best practices, and latest compliance-related industry and regulatory intelligence.
Responsible for active management of the Compliance resource model, identifying risks and potential efficiencies to ensure business needs and budgetary expectations are met and aligned with strategic direction.
This position will have direct reports and may have oversight of external resources
Qualifications
Bachelor’s degree (or ex-US equivalent) is required; advanced degree preferred
10+ years of pharmaceutical, healthcare, or clinical research related experience; Compliance or Quality experience within highly regulated industry preferred
5+ years of people leadership experience, or extensive evidence, demonstrating successful leadership in highly dynamic, global, and matrixed environment
Demonstrates excellence in people leadership and development, leading cross-functional teams, and fostering global team productivity and cohesiveness
Able to translate organizational vision and mission into operational strategy, plan, and execution
Considered a Subject Matter Expert and competent in the application of AbbVie's Quality Manual principles, standard business procedures, and GCP-related regulations
Key Stakeholders
Senior Leaders within Clinical Development Operations, Regulatory, Quality Assurance, Pharmacovigilance, Legal, Data & Statistical Sciences, Clinical Drug Supply Management, TAMD program and study teams
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation 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 we may ultimately pay more or less 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.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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