Key Skills

Job Description

Compliance Improvement Lead Location: Leiden (hybrid/fully onsite, minimum 4 days per week) Duration: Start ASAP - 12-month contract with potential for extension Hours: Full-time, 40 hours per week The project focuses on shaping compliance and GMP specifically for the Leiden site. The role involves taking ownership of existing and new improvement plans, providing back-office support, training, and acting as a senior consultant to guide the wider organization, collaborating with a core team of 10 while impacting a broader organization of around 1,000 people. roles and responsibilities Translate compliance gaps into clearly defined remediation actions and improvement projects. Prioritise activities based on quality and compliance risk. Drive remediation activities from identification through implementation and sustainable closure. Support Operations in strengthening day-to-day adherence to GMP requirements. Review existing procedures and working practices from a GMP compliance perspective. Support updates to procedures resulting from regulatory requirements, investigations, audit findings or identified compliance gaps. Help translate GMP requirements into clear and practical standards for Operations. Support development of GMP training or awareness activities where these are required as part of remediation. Establish structured compliance improvement plans with actions and deliverables. Ensure the changes are aligned and implemented in a compliant way. Coordinate cross-functional remediation activities with Operations, Quality and relevant stakeholders. Monitor progress and provide transparent reporting on compliance risks, remediation activities and open actions. Provide back-office support and training. Set the direction, take ownership, and work independently how to succeed Relevant Bachelor's/HBO degree or equivalent professional experience. At least 5 years of relevant experience in a GMP-regulated pharmaceutical or biopharmaceutical environment as compliance specialist. Strong practical knowledge of cGMP requirements and quality systems. Proven ability to independently drive cross-functional improvement projects. Strong stakeholder management and communication skills. Highly structured and results-oriented, with the ability to manage multiple compliance actions and priorities. Able to work independently while effectively partnering with Operations and Quality. Good command of English. Capability to set direction, take ownership, and operate as an experienced Compliance Specialist and senior consultant. benefits This role offers a very competitive hourly rate. This contract will run for 12 months with potential for extension you are welcome here Mentor/Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. about Mentor, Leiden Part of Johnson & Johnson, Mentor sells and produces breast implants for reconstruction and augmentation purposes worldwide from their state of the art site in Leiden. With a proud history as a global leader in breast aesthetics, we believe that innovation should be driven by what patients need and should be backed by solid research, high design and thorough testing. Contribute to the next healthcare breakthrough with your next project at Mentor. application process We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email or LinkedIn InMail - you must apply direct to this advert. Diversity, Equity & Inclusion For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Core Responsibilities

Lead compliance improvement and remediation plans from identifying gaps through implementation and sustainable closure, prioritizing actions according to quality and compliance risk. Support Operations and Quality by reviewing procedures, translating GMP requirements into practical standards, coordinating cross-functional work, providing training, and reporting progress and open risks.

Requirements

Requires a relevant bachelor's degree or equivalent professional experience and at least five years of compliance experience in a GMP-regulated pharmaceutical or biopharmaceutical environment. Candidates should have strong practical knowledge of cGMP and quality systems, a record of independently leading cross-functional improvement projects, strong stakeholder and communication skills, and good English.

Benefits

• Competitive Hourly Rate