Senior Associate Director, Compliance Management

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.

This is a senior global quality and compliance leadership role focused on strengthening GxP compliance and quality excellence across critical business functions.

You will generate actionable insights that shape quality strategy, support operational decision-making, and promote a proactive compliance culture.

The role combines compliance consulting, risk assessment, quality issue management, and continuous process improvement in a highly regulated environment.

You will partner closely with Clinical Operations, Medicine, Quality Management, and other cross-functional teams to address complex compliance topics.

The position also provides opportunities to support clinical development programs, inspections, due diligence activities, and external partnering assessments.

You will contribute to the development of best practices, training, and efficient compliance processes while driving sustainable quality improvements.

This role is ideal for an experienced pharmaceutical or CRO professional who can operate strategically while providing practical, solutions-oriented guidance.

Accountabilities:

• 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.

Requirements:

• 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.

Benefits:

• 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.