Compliance Manager, Clinical Process Compliance supports the interpretation and application of GCP and regulatory principles into action in support of Development and business partners to drive execution of high quality clinical trial conduct with minimal supervision. Leads issue management activities for business partners demonstrating excellence in the identification, assessment and delivery of documentation of potential non-conformities, non-conformities, and oversight of effectivity checks with limited managerial oversight. Demonstrates high degree of competence in delivering effective issue escalation and business continuity meetings.
- Partners with Business Process (BP), Functional and Development Leaders to support delivery of program, business process and functional compliance-related deliverables with minimal management oversight. Partner with peers to share best practices and to align in delivery of strategic objectives.
- Able to translates the vision, mission, and operational tactics of Clinical Process Compliance and apply them to functional deliverables, including but not limited to issue capture, assessment and documentation.
- Oversees compliance metrics for assigned Business Process (BP), function, and delivers on-time and comprehensive compliance metrics to support functional activities and overarching compliance metrics for Sr Leadership and business partners. Using expertise to providing interpretation of possible signals or trends.
- Drive meetings and discussions, managing delivery of actions to closure, and general oversight of the business continuity plan for Development Operations as it impacts areas or BPOs supported with minimal managerial oversight.
- Represents Clinical Process Compliance in various initiatives within Development Operations or drives initiatives within Clinical Compliance.
- Apply and lead discussions with business partners regarding application of Quality Manual principles in support of the ways we work.
- Effectively manages, prioritizes and balances work activities for areas supported to effectively utilize resources to ensure business needs are met.
- Reviews new and revised regulations, determining and interpreting content and implications with business partners to assess impact to clinical trial conduct and associated processes. Drives discussions with business partners relative during procedural or process changes to ensure regulatory requirements are understood and maintained.
- Drive inspection support by Clinical Process Compliance for Development (inspection support, response review and coordination, evidence review) with minimal oversight.
- Responsible for understanding AbbVie's Quality System, Regulations related to GXP activities and Development systems used in the conduct of a clinical trial.
- Assessment of new and revised regulations to determine compliance impact to business processes and clinical trial execution.
- Provide compliance related guidance in accordance with global SOP and GCP regulations to our business partners.
- Participate in assessment of regulatory trends to identify issues that could traverse multiple functions and therapeutic areas.
- Participate assessment of quality and compliance trends to drive a proactive approach to compliance within AbbVie clinical trial execution
- BS or BA required; advanced degree preferred.
- Quality certification is a plus.
- 6+ years’ experience in Pharma or Related Field (e.g. Compliance or Quality leader)
- Demonstrates analytical and critical thinking skills.
- Possesses good communication skills and demonstrated leadership abilities and problem-solving skills.
- Able to translate strategy into operations and manage multiple changing priorities.
- Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced