Local Compliance Manager

We are looking for a driven Local Compliance Manager to join our Clinical Operations team in The Netherlands and Belgium. You will contribute in building a strategically sound local quality plan to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations. You will also ensure our team is adequately trained and onboarded. Our new colleague should be flexible and able to work independently. We are seeking to hire a strong communicator, a leader and team player, with quick learning and problem-solving abilities. The Compliance Manager will collaborate with the Country Head, the Clinical Research Managers and the teams, carrying out the clinical trials, consisting of Local Trial Managers (LTM), Site Managers (SM) and Clinical Trial Assistants (CTA). You will be part of a hardworking, enthusiastic, and committed team of +/- 170 people eager to deliver and helping to improve the lives of millions of patients.

Principal Responsibilities:

• Quality and Compliance Oversight: Contribute in building a local longterm strategically sound quality plan; proactively measure and identify compliance risks and define remediation actions; supervise progress and confirm effectiveness of remediation plans and conduct QC checks on trials and processes; lead preparation and oversight of inspections and audits and the management of CAPA's; leads process improvement initiatives.
• Local onboarding and consultation: support onboarding of new hires; organize local workshops, trainings and lessons learned to increase compliance awareness. Be the go-to person for risk management and provide advice for complex situations to ensure timely resolution of issues.
• Local regulatory intelligence: perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams. Keep local intelligence up to date.
• Collaboration with business quality: perform local supplier assessments; coordinate annual due diligence update, certification and training of local suppliers.
• Leads local compliance meetings.
• Leads and/or participates in special (global) initiatives as assigned.
• May assume additional responsibilities or special initiatives such as 'Champion', ''Subject Matter Expert' or 'Business Process Owner'.

Education and Experience Requirements:

• BA/BS degree in Life Sciences or related scientific field (or 8-10 years equivalent experience)
• A minimum of 6 years of previous pharmaceutical industry experience is required with at least 4-6 years of GxP experience within clinical research and/or quality assurance. Other relevant working experiences and skills may be considered by the hiring manager. Experience in phase 1, 2, 3 clinical trials is a plus.
• Strong proven understanding of GCP, local laws, and regulations
• Advanced skills and knowledge of business processes and practices
• Ability to present in a clear and concise way - strong communication skills
• Strong interpersonal skills
• Proven project leadership skills
• Willingness to engage with authorities, trade associations and key sites
• Proficient in Dutch, English and French (for Belgian candidates)

Preferred Skills:

Analytical Reasoning, Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Execution Focus, Fact-Based Decision Making, Laboratory Operations, Mentorship, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Standard Operating Procedure (SOP), Technical Credibility

Location: Breda, NL