Senior Associate Director, Compliance Management
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Job Description
Senior compliance leader driving GxP quality strategy, NC/CAPA processes, and clinical inspection readiness. Supporting Boehringer Ingelheim’s pharmaceutical product development and global quality initiatives.
Responsibilities:
- Lead the generation of timely and actionable outputs and knowledge that inform and drive quality strategy and operations for assigned functions/areas
- Apply proactive compliance, maintain high quality transparency, and foster a culture of quality excellence
- Support clinical development teams with trending and analysis, risk assessments, and inspection readiness when assigned to Therapeutic Areas
- Provide GxP compliance consultancy to Medicine business functions
- Support global quality initiatives, quality issues, inspections, and compliance topics
- Develop best practices for compliance processes, focusing on innovation, effectiveness, and efficiency
- Define and deliver training for NC/CAPA processes and other compliance topics
- Act as a cross-functional compliance expert and provide GxP guidance
- Share best practices within QM and Medicine business functions
- Initiate updates to relevant process descriptions and guidelines
- Support root cause analysis and identification of adequate CAPAs
- Ensure effectiveness checks after implementation of actions
- Support teams with Quality tools and methods
- Perform process analysis and optimization
- Support IDE projects by assessing GCP compliance when assigned
- Support Partnering projects when BI’s GCP compliance is assessed by external potential future partners
- Define and implement support strategies for clinical development projects when assigned to a Therapeutic Area
- Provide recommendations based on risk assessments for continuous improvements
- Support compliance questions and global improvement initiatives
Requirements:
- Bachelor’s degree and/or Master’s degree (e.g. MBA, MSc)
- Minimum of twelve (12) years in pharmaceutical / CRO industry
- Minimum of seven (7) years’ experience in Clinical Operations and/or other BI Medicine functions
- Minimum of five (5) years’ experience in Non-Compliance (NC) and Corrective Action / Preventive Action (CAPA) management processes, including Root Cause Analysis methodologies
- Eight-plus (8+) years of experience in GxP quality management system
- Experience interacting with Regulatory Authorities, e.g. regulatory inspections
- Strong interpersonal, cultural, and communicational skills
- Solution oriented
- Strong organizational and project management skills
- Proficient knowledge of applicable regulations, company processes and procedures, with ability to assess their impact
- Travel as needed
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical, if required
- Must be 18 years of age or older
Benefits:
- Competitive compensation and benefit programs
- Healthy working environment
- Meaningful work
- Mobility opportunities
- Networking opportunities
- Work-life balance
- Role-specific variable or performance-based bonus and/or other compensation elements
- Drug test and post-offer physical if required
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