Compliance Director

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Associate Director, Compliance Management based in United States.

• Lead the generation of timely, actionable quality and compliance insights that inform strategy, operational priorities, and continuous improvement across assigned functions and areas.
• Provide expert GxP compliance guidance to business teams and act as a trusted cross-functional advisor on quality management and regulatory matters.
• Develop and deliver training on Non-Compliance (NC), Corrective and Preventive Action (CAPA), root cause analysis, and other relevant compliance processes and topics.
• Promote the sharing of quality and compliance best practices across Quality Management and Medicine functions, helping teams adopt effective and consistent approaches.
• Initiate and support updates to relevant processes, procedures, guidelines, and compliance frameworks as business and regulatory requirements evolve.
• Support global quality issues, compliance topics, and improvement initiatives by helping teams conduct robust root cause analyses and develop appropriate CAPA plans.
• Evaluate the effectiveness of implemented actions and support teams in establishing appropriate effectiveness checks to ensure sustainable remediation.
• Apply quality tools, methodologies, process analysis, and optimization techniques to improve compliance processes and operational effectiveness.
• Support In-Depth Evaluation (IDE) and due diligence projects by assessing Good Clinical Practice (GCP) compliance when assigned.
• Contribute to partnering activities where GCP compliance is evaluated by potential external partners.
• When aligned to a Therapeutic Area, develop and implement strategies supporting clinical development programs, including trending, analysis, risk assessment, and continuous improvement recommendations.
• Support clinical development teams with compliance questions, quality initiatives, risk-based recommendations, and inspection readiness activities.
• Contribute to global quality initiatives, compliance programs, inspections, and other strategic quality topics as assigned.

• Bachelor’s and/or Master’s degree, such as an MBA, MSc, or a related discipline.
• At least 12 years of professional experience within the pharmaceutical or Contract Research Organization (CRO) industry.
• At least 7 years of experience in Clinical Operations and/or Medicine-related business functions.
• Minimum of 5 years of experience managing Non-Compliance (NC) and Corrective and Preventive Action (CAPA) processes, including experience with root cause analysis methodologies.
• At least 8 years of experience working within a Good Practice (GxP) quality management system.
• Demonstrated experience interacting with Regulatory Authorities, including supporting or participating in regulatory inspections.
• Strong knowledge of applicable regulations, internal processes, and procedures, with the ability to evaluate their operational and compliance impact.
• Strong interpersonal, communication, and cross-cultural collaboration skills, with the ability to work effectively across global and multidisciplinary teams.
• A solution-oriented mindset with strong analytical, organizational, and project management capabilities.
• Ability to build trust, communicate with confidence, collaborate effectively, and make timely, well-informed decisions.
• Strong responsiveness, accountability, assertiveness, and professional judgment when managing complex compliance matters.
• Willingness to travel as required by business needs.
• Must be legally authorized to work in the United States without restriction.
• Must be at least 18 years of age and willing to complete a drug test and post-offer physical examination if required.

• Base salary typically ranging from $170,000 to $269,000, depending on qualifications, experience, and other relevant factors.
• Potential eligibility for a role-specific variable or performance-based bonus and/or additional compensation elements.
• Senior-level exposure to global quality strategy, GxP compliance, clinical development, regulatory inspections, and pharmaceutical quality management.
• Opportunities to collaborate with cross-functional and international teams on strategic quality initiatives and complex compliance matters.
• Professional growth through involvement in quality transformation, process optimization, risk management, training, and continuous improvement initiatives.
• Exposure to clinical operations, regulatory authorities, due diligence, partnering assessments, and inspection-readiness activities.
• An environment focused on quality excellence, meaningful work, collaboration, professional development, and work-life balance.