GMP Compliance Specialist

GMP Compliance Specialist

Location: Leiden

Working mode: On-site 3-4 days per week

Duration: Until the end of 2024 (opportunity for a contract extension)

Pay rate range: Competitive hourly rate

Imagine your next project as GMP Compliance Specialist. Supports the QSC (Quality Systems and Compliance) team to ensures a professional, up to date, high quality level of JBV’s core Quality Systems and its application of these systems to maintain and improve the compliance status of JBV’s processes and systems in line with the regulatory, JBV, Janssen Supply Chain and J&J standards. Supports development and updates to quality systems and procedures when appropriate. Advises Q&C Management and the executing departments regarding compliance issues and ensures resolution.

roles and responsibilities

• Acts as a Centre of Expertise for GMP core quality systems.

• Maintains and improves GMP core quality systems, ensuring that the JBV quality systems are compliant, state-of-the-art, and efficient.

• Ensures consistency in the quality systems across processes and departments.

• Has an outstanding knowledge of GMP regulations, Janssen and J&J standards and translates these requirements in JBV systems that are compliant.

• Uses appropriate assessment tools (e.g., PE, Lean, Risk Management principles) in assessing the status of current quality processes and in introducing improvements.

• Ensures that quality initiatives are implemented effectively across all relevant operational (Quality) departments.

• Ensures good communication with all departments and functional groups within JBV involved in GMP work.

• Ensures that JBV management stays adequately informed.

• Ensures that performance, quality, and compliance reviews are made, followed up and shared with upper management.

Magnitude & Complexity

The focus of the function is to support the QSC compliance specialists to ensure that the core quality systems at JBV meet the current industry and regulatory standards. The position requires a strong analytical and independent thinking and decision making to find structural and regulatory-wise sound solutions for issues identified.

Extensive, in depth up-to-date knowledge of quality systems and recent developments in this expertise area is a requirement.

how to succeed

Minimum education required:

Bachelor/Master’s degree or equivalent in relevant area

Minimum experience required:

• Pharmaceutical or related industry work experience for min. 5 years

• Experience in a complex, multinational work environment/company

• Analytical, innovative, and pragmatic thinking

• Excellent communicational and advisory skills, result oriented.

Other Requirements

• Language: Dutch or English

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2024 and has a chance of extension. 

you are welcome here

Janssen 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 Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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. The pay rate for this role will depend on how you are paid. Options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsouright.co.uk (please note we do not accept applications via email)

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”.