Quality & Compliance Lead - Regulatory Inspection (Hybrid)

Boehringer Ingelheim GmbH; Ridgefield (CT); Hybrid; USD 170,000 - 269,000; Full time

Job summary

Boehringer Ingelheim in Ridgefield, CT, seeks a Senior Associate Director, Quality & Compliance Lead, a hybrid role 2–3 days onsite weekly. You will drive GxP topics, ensure patient safety and data integrity, and lead audits and regulatory interactions.

The role demands leadership, deep GCP experience, and collaboration across BI US and global teams to continuously strengthen the Quality Management System.

Qualifications

• Minimum Bachelor's degree required; advanced degree preferred.
• Minimum eight (8) years proven GCP depth, experience with inspection management required.

Responsibilities

• Provide quality and compliance consultancy to enable R&D and regulatory activities in BI US.
• Lead FDA and other inspections end-to-end (inspection preparation, conduct and post inspection management).
• Develop and maintain the global Quality Management System and tailor to the US OPU to comply with local regulatory requirements.
• Collaborate with Medicine functions and other business partners to ensure quality and compliance requirements are understood.
• Lead the preparation of Quality Management Review reports and meetings with key stakeholders.
• Implement and maintain global procedures in a pragmatic, clear and concise way for US adherence.

Skills

Communication

Leadership

Data analytics

Project management

Risk management

Presentation skills

Influencing

Critical thinking

Education

Bachelor's degree

Advanced degree (PharmD, Ph.D., Master’s)

Job description

Boehringer Ingelheim in Ridgefield, CT, seeks a Senior Associate Director, Quality & Compliance Lead, a hybrid role 2–3 days onsite weekly. You will drive GxP topics, ensure patient safety and data integrity, and lead audits and regulatory interactions.

The role demands leadership, deep GCP experience, and collaboration across BI US and global teams to continuously strengthen the Quality Management System.