Senior Associate Director, Compliance Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the creation of timely and actionable outputs and insights that inform and enhance quality strategy and operations for designated functions/areas.

• Implement proactive compliance measures, uphold high-quality transparency, and promote a culture of quality excellence.

• Assist clinical development teams with trend analysis, risk assessments, and preparation for inspections when assigned to Therapeutic Areas.

• Offer GxP compliance consultancy to Medicine business functions.

• Contribute to global quality initiatives, address quality issues, manage inspections, and tackle compliance topics.

• Establish best practices for compliance processes, with an emphasis on innovation, effectiveness, and efficiency.

• Design and deliver training on NC/CAPA processes and other compliance subjects.

• Serve as a cross-functional compliance expert and provide GxP guidance.

• Disseminate best practices across QM and Medicine business functions.

• Initiate updates to pertinent process descriptions and guidelines.

• Assist in root cause analysis and the identification of appropriate CAPAs.

• Ensure effective checks following the implementation of actions.

• Support teams utilizing quality tools and methodologies.

• Conduct process analysis and optimization.

• Aid in IDE projects by evaluating GCP compliance when assigned.

• Support Partnering projects when assessing BI’s GCP compliance with external potential future partners.

• Define and execute support strategies for clinical development projects when assigned to a Therapeutic Area.

• Provide recommendations for continuous improvements based on risk assessments.

• Address compliance inquiries and contribute to global improvement initiatives.

⛳️ Requirements

• Bachelor’s degree and/or Master’s degree (e.g., MBA, MSc).

• At least twelve (12) years of experience in the pharmaceutical/CRO industry.

• A minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions.

• At least five (5) years’ experience in Non-Compliance (NC) and Corrective Action/Preventive Action (CAPA) management processes, including Root Cause Analysis methodologies.

• Over eight (8+) years of experience in GxP quality management systems.

• Experience in interactions with Regulatory Authorities, including regulatory inspections.

• Excellent interpersonal, cultural, and communication skills.

• Solution-oriented mindset.

• Strong organizational and project management abilities.

• Proficient understanding of relevant regulations, company processes, and procedures, with the ability to evaluate their impact.

• Willingness to travel as necessary.

• Must be legally authorized to work in the United States without restrictions.

• Must be open to undergoing a drug test and post-offer physical, if required.

• Must be 18 years of age or older.

🏝️ Benefits

• Competitive compensation and benefits packages.

• Supportive working environment.

• Meaningful and impactful work.

• Opportunities for mobility.

• Networking opportunities available.

• Work-life balance promotion.

• Role-specific variable or performance-based bonuses and/or other compensation elements.

• Drug test and post-offer physical, if required.