Global Head of Quality Assurance and Compliance

Overview / About us

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus : Strategic Consulting & Insights, Value, Access & Outcomes, Medical Strategy & Communications, and Real-World Evidence.

Responsibilities / Position overview

We are hiring for a Head of Quality Assurance and Compliance to join our global team.

The Head of Compliance directs and has ultimate responsibility for all client compliance activities described in relevant Master Services agreements or defined in applicable SOPs, these include safety reporting, data privacy, and ethics considerations. This role supports the company by maintaining robust compliance systems, leading audits, and providing training and certification management. The Head of Compliance leads in creation and management of compliance related processes and people, drives continuous improvement of initiatives and develops specialized compliance areas to enhance value for project teams and clients. The Head of Compliance is an integral part of Lumanity Central team, supporting all operating companies and teams.

To be successful in this role you will :

• Direct and guide all aspects of client compliance, including safety reporting, data privacy considerations, ethics considerations, and other client-specific requirements.
• Manage and develop the Lumanity Compliance team – ensuring they are equipped and able to meet the needs of the business.
• Develop systems to support and enhance internal compliance practices, ensuring they are efficient and robust.
• Lead and coordinate Pharmacovigilance (PV) audits, including information collection, scheduling, audit support, and oversight of findings and implementation of Corrective and Preventive Actions (CAPAs).
• Respond to client risk assessments and compliance questionnaires
• Continuously seek opportunities to improve compliance systems through automation and technology to enhance efficiency while maintaining stringent compliance standards.
• Direct the design of mandatory training : ensuring Lumanity is equipped with tools to address compliance requirements with supporting rollout of company-wide mandatory training
• Create and maintain company Standard Operating Procedures (SOPs) and client-specific guidelines, ensuring they are up to date and compliant with industry standards.
• Conduct internal audits to ensure compliance with MSAs, company policies and applicable regulations

Qualifications

Benefits

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