Senior Training and Compliance Manager

CR2O | Clinical CRO; Maarssen; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Flexible working

Hybrid working environment

Job summary

CR2O | Clinical CRO is seeking a Senior Training & Compliance Manager to lead our training, compliance, and quality initiatives. You will advise Clinical Operations, help ensure inspection readiness, and contribute to the strategic development of the Training & Compliance team.

The role blends hands-on regulatory activities with strategic planning, offering an impactful position in a growing CRO focused on quality, compliance, and continuous improvement.

Qualifications

• BSc, MSc or equivalent degree in Life Sciences or a related field.
• At least 7 years of experience in clinical research within a CRO/pharma/biotech environment, with significant Training/Compliance exposure.
• Strong knowledge of ICH E6 (R3), CTR, GDPR and related guidelines/regulations.
• Experience with training programs, compliance reviews, oversight, and inspection readiness.
• Fluent in English; Dutch is a plus.

Responsibilities

• Advise clinical project teams on compliance and inspection readiness.
• Act as subject matter expert on GCP, regulatory requirements, training management and compliance management.
• Perform hands-on compliance activities to support the maintenance of the QMS.
• Lead and support training initiatives to strengthen knowledge, competence and quality awareness.
• Partner with QA and operations to strengthen risk-based quality management.
• Author Compliance SOPs and Training SOPs.
• Mentor colleagues and promote accountability and continuous improvement.

Skills

Training management

Quality systems

GCP knowledge

Regulatory compliance

Communication skills

Education

BSc/MSc in Life Sciences

Job description

As we continue to grow, we are looking for a Senior Training & Compliance Manager who combines deep clinical research expertise with a hands‑on mindset. In this role, together with your colleagues in the Training and Compliance team, you will lead, support and further develop our training, compliance, and quality initiatives across the organization.

You will act as a trusted advisor to Clinical Operations and project teams, helping to ensure inspection readiness, regulatory compliance, and operational excellence. At the same time, you will contribute to the strategic development of the Training & Compliance department by identifying opportunities for improvement, supporting departmental initiatives, and helping shape the future of quality at CR2O.

This role is ideal for someone who enjoys both operational involvement and strategic thinking.

As Senior Training & Compliance Manager, you will:

• Advice clinical project teams in maintaining compliance and inspection readiness
• Act as a subject matter expert on GCP, regulatory requirements, training management and compliance management
• Perform hands‑on compliance activities to support the maintenance of our QMS
• Lead and support training initiatives that strengthen knowledge, competence, and quality awareness
• Serve as a strategic sparring partner to the Director Quality Assurance, Training & Compliance
• Contribute to the continuous improvement and future development of the Training & Compliance department

Key Responsibilities

Training

• Create and maintain role specific training programs
• Identify training needs to ensure operational excellence company wide
• Support trainers to develop and improve training materials
• Ensure training requirements remain aligned with procedural and regulatory changes
• Support employees and line managers in maintaining inspection‑ready personnel training files
• Monitor training compliance
• Lead the further development of CR2O's training framework and learning culture
• Author Training SOPs

Quality Management System

• Lead the ongoing maintenance and development of procedural documents (SOP/WI/templates)
• Ensure the procedural documents remain aligned with regulatory changes and industry trends

Compliance

• Create and execute the annual compliance program
• Perform compliance reviews and identify risks, gaps, and improvement opportunities
• Monitor and help resolve compliance issues in collaboration with project teams
• Partner with Quality Assurance and operational teams to strengthen risk‑based quality management
• Author Compliance SOPs
• Support the Director Quality Assurance, Training & Compliance in shaping departmental priorities and initiatives
• Lead or contribute to cross‑functional improvement projects
• Act as a mentor and role model for colleagues
• Promote a culture of accountability, collaboration, learning, and continuous improvement
• Actively contribute to the growth and maturity of CR2O's quality culture

Qualifications

• BSc, MSc or equivalent degree in Life Sciences or a related field
• At least 7 years of experience in clinical research within a CRO, pharmaceutical, or biotechnology environment, including significant experience in Training and/or Compliance
• Strong knowledge of ICH E6 (R3), CTR, GDPR and other applicable guidelines and regulations
• Experience with training programs, compliance reviews & oversight, quality management systems, and inspection readiness
• Strong analytical and communication skills
• Ability to work independently and drive initiatives to completion
• Fluent in English. Dutch is considered an advantage
• Experience with the implementation of an eQMS is a plus

What We Offer

• A strategic and operational combined role with direct impact on the organization
• Close collaboration with leadership
• Opportunity to shape and strengthen the quality culture
• Competitive salary and attractive benefits package
• Flexible and hybrid working environment