Quality & Compliance Lead: Global GxP & Patient Safety

BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.; Singapore; On-site; SGD 180,000 - 300,000; Full time

Job summary

Boehringer Ingelheim Singapore Pte. Ltd.

is seeking a Quality and Compliance Lead to drive GVP and GCP initiatives across the network, ensuring patient safety, data integrity, and regulatory compliance throughout the drug and device lifecycle. You will lead QMS improvements, provide strategic quality guidance for regulatory submissions and market authorizations, and collaborate with Medicine functions to embed quality by design and continuous improvement.

Qualifications

• Master's degree preferred; Life Sciences degree required.
• Minimum 5 years of experience in Quality, Compliance, or related functions.
• Strong knowledge of ICH-GCP, ICH-GVP, clinical development, pharmacovigilance, and regulatory requirements.
• Experience with Quality Management Systems (QMS), Non-Compliance (NC), CAPA, and Root Cause Analysis.
• Experience supporting regulatory inspections and audits.
• Ability to work effectively in a matrix and cross-functional environment.
• Strong communication, stakeholder management, and influencing skills.
• Proven leadership experience in quality initiatives, projects, or cross-functional teams.
• Strong analytical, critical thinking, and problem-solving skills.
• Effective presentation and facilitation skills.

Responsibilities

• Develop, maintain, and improve the global QMS, aligning with local regulatory requirements.
• Partner with Head of Quality Management to prepare governance meetings.
• Support development and monitoring of quality objectives and plans.
• Act as deputy for the R/OPU Head of QM when required.
• Serve as trusted Quality & Compliance advisor to Medicine functions and stakeholders.
• Assess impact of Regulatory Intelligence Network updates on quality processes.
• Lead and contribute to global quality initiatives and continuous improvement.
• Coordinate documentation, calibration of procedures, and KMED assets.
• Lead regulatory inspections end-to-end and manage responses.

Skills

Quality leadership

Stakeholder management

Analytical thinking

Presentation & facilitation

Problem solving

Education

Bachelor's degree Life Sciences

Master's degree preferred

Tools

QMS

Job description

Boehringer Ingelheim Singapore Pte. Ltd.

is seeking a Quality and Compliance Lead to drive GVP and GCP initiatives across the network, ensuring patient safety, data integrity, and regulatory compliance throughout the drug and device lifecycle. You will lead QMS improvements, provide strategic quality guidance for regulatory submissions and market authorizations, and collaborate with Medicine functions to embed quality by design and continuous improvement.