Senior Manager, Clinical Compliance

Senior Manager, Clinical Compliance

The Senior Manager, Clinical Compliance will lead efforts in GCP Inspection Readiness by partnering with QA and functional areas to define inspection focus areas and support planning activities. This role is central to managing study team deliverables, coordinating SME preparation activities, and leading process improvement initiatives. Additionally, the position supports SOP and training enablement, issue management, and quality events.

Responsibilities:

• Partner with QA and functional areas to define inspection focus areas and support inspection readiness planning activities.
• Manage study team inspection readiness deliverables, including storyboards, document preparation, and interview readiness.
• Lead and coordinate SME and functional area preparation activities, serving as the central point of coordination.
• Lead and manage process improvement initiatives, including the creation, enhancement, and revision of operational processes.
• Ensure strong alignment between functional workflows, SOP frameworks, and quality system requirements.
• Support functional areas in identifying SOP needs, authoring, reviewing, and performing periodic reviews.
• Identify training needs and support the development, authoring, and delivery of functional area training related to operational processes and quality expectations.
• Support internal and external issue management activities, including issue categorization, investigation participation, and deviation documentation.
• Guide study teams and functional areas in defining effective CAPAs and tracking CAPA completion.
• Partner with QA and other stakeholders to escalate quality events, potential serious breaches, and significant areas of concern through established escalation pathways.

Essential

Skills:

• Bachelor's degree in Life Sciences, Pharmacy, or a related scientific discipline.
• Minimum 8–10 years of experience in Clinical Quality Assurance, GCP Compliance, Clinical Operations, or related quality functions within the pharmaceutical, biotechnology, or CRO industry.
• Minimum 3–5 years of experience leading inspection readiness initiatives or quality projects.
• Experience supporting sponsor organizations and global clinical development programs.
• Experience supporting FDA and/or international regulatory inspections.
• Certified Quality Auditor (ASQ CQA), RQAP-GCP, or equivalent certification preferred.

Additional Skills &

Qualifications:

• Extensive experience with global GCP inspection readiness programs.
• Experience with FDA, EMA, MHRA, PMDA, Health Canada, or other regulatory inspections.
• Experience with mock inspections and inspection simulations.
• Experience with inspection request management and logistics.
• Experience with Trial Master File (TMF) health checks and remediation.
• Experience with Quality Management Systems (QMS).
• Experience with CAPA development and Root Cause Analysis.
• Experience with vendor qualification and oversight.
• Experience with cross-functional project leadership.
• Strong understanding of ICH E6(R3) Good Clinical Practice.
• Strong understanding of FDA GCP regulations (21 CFR Parts 11, 50, 54, 56, and 312).
• Strong understanding of applicable EU Clinical Trial Regulation.
• Strong understanding of Risk-Based Quality Management (RBQM).
• Strong understanding of ALCOA+ principles and data integrity requirements.
• Strong understanding of Trial Master File Reference Model.
• Strong understanding of Quality Risk Management principles (ICH Q9).
• Strong understanding of Corrective and Preventive Action (CAPA) methodology.
• Demonstrated ability to lead cross-functional inspection readiness initiatives.
• Demonstrated ability to manage multiple inspection readiness projects and develop inspection strategies and readiness plans.
• Demonstrated ability to assess organizational compliance risks and recommend mitigation strategies.
• Demonstrated ability to facilitate inspection readiness meetings and working groups.
• Demonstrated ability to build collaborative relationships across functional areas.
• Demonstrated ability to present quality and compliance information to Senior leadership.

Work Environment:

This is a remote position, with a preference for candidates who can work in the Eastern…