Senior Associate Director, Compliance Management

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $170k - $269k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• 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