Director, Clinical Process Compliance

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 requires onsite work at AbbVie locations. The expected onsite days are Tuesday Wednesday and Thursday each week. 

• Illinois (IL): North Chicago Massachusetts (MA): Worcester New Jersey (NJ): Branchburg Florham Park California (CA): Irvine South San Francisco
  
   
• 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 :

• Bachelors 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 AbbVies 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time