Quality and Compliance Lead, HP ROPU ASKAN

THE POSITION

The Quality and Compliance Lead (QCL) serves as the key Quality and Compliance subject matter expert for the organization, driving Good Vigilance Practice (GVP) and Good Clinical Practice (GCP) initiatives across the Boehringer Ingelheim network to proactively ensure patient safety, data integrity, and regulatory compliance throughout the drug and device lifecycle. This role leads the identification, assessment, and mitigation of quality and compliance risks, while championing continuous improvement of the Quality Management System (QMS). The QCL provides strategic guidance and expert consultancy to support efficient research and development activities, regulatory submissions, market authorizations, and the maintenance of product licenses within the assigned Regional Operating Unit (R/OPU). In addition, the role contributes regional insights to the Global Quality Medicine Strategy and ensures its effective execution at the local level, balancing local business needs with a global quality and compliance mindset.

Tasks & responsibilities

• Develop, maintain, and continuously improve the global Quality Management System (QMS), ensuring alignment with local regulatory requirements within the (R)OPU.
• Partner with the Head of Quality Management (QM) to prepare and facilitate Quality Management Reviews and related governance meetings.
• Support the development, implementation, and monitoring of quality objectives and quality plans.
• Act as deputy for the R/OPU Head of QM, as required.
• Serve as a trusted Quality & Compliance advisor, partnering with Medicine functions and key stakeholders to ensure understanding and application of quality and regulatory requirements.
• Assess and manage the impact of Regulatory Intelligence Network (RIN) updates on quality and compliance processes, escalating risks and issues as needed.
• Promote a strong quality culture by embedding Quality by Design principles into business processes and practices.
• Lead and contribute to local, regional, and global quality initiatives, projects, and continuous improvement activities.
• Implement and maintain global procedures while ensuring compliance with local regulatory and business requirements, including management of local documents and KMED assets.
• Collaborate with Medicine functions to identify learning, training, and qualification needs, and support organizational adoption of new processes and ways of working.
• Coordinate communication and translation of quality-related updates and ensure process documentation remains current and effective.
• Lead regulatory inspections end-to-end, including preparation, execution, regulatory interactions, response management, and implementation of lessons learned.
• Contribute to audit planning and execution, ensure timely investigation and closure of findings, and conduct audits as lead, co-, or BI responsible auditor when qualified.
• Define, manage, and oversee supplier qualification and performance in collaboration with internal stakeholders, ensuring effective supplier compliance, CAPA management, and periodic reviews.
• Identify, assess, and mitigate compliance risks and gaps through ongoing monitoring, quality assessments, and process improvements.
• Provide quality analytics, trending, and insights to drive compliance and operational excellence across Medicine functions.
• Act as the subject matter expert for Non-Compliance and Issue Management, leading investigations, root cause analysis, and development of effective CAPAs.
• Serve as Project Quality & Compliance Lead (PQCL) for projects and clinical trials, providing strategic quality oversight and compliance guidance in collaboration with global teams.

Requirements

• Master’s degree preferred; Bachelor’s degree in Life Sciences or a related scientific field required.
• Minimum 5 years of experience in Quality, Compliance, or related functions.
• Strong knowledge of ICH-GCP, ICH-GVP, clinical development, pharmacovigilance, and applicable 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.
• Experience in risk assessment and risk management.
• Strong project management skills with the ability to deliver multiple priorities successfully.