Senior Quality Governance Lead

Senior Quality Governance Lead (Operational)

Location: Leiden

Working mode: On-site

Duration: 6 months

Languages: English and Dutch

Hours: 3-4 days per week, max 32 hours per week

The Senior Quality Governance Lead within the Biotherapeutics Operations organization in Leiden is responsible for setting direction and ensuring the integrity of quality processes across the business unit. This role provides leadership in managing quality records—such as non-conformance (NC), deviations, corrective and preventive actions (CAPA), and change controls—while driving a culture of compliance and continuous improvement.

key responsibilities:

• Strategic Oversight: Define and enforce standards for quality investigations, ensuring robust root cause analysis and alignment with regulatory expectations.

• Leadership & Coaching: Mentor Quality Engineers and influence investigation quality, fostering strong problem-solving and decision-making capabilities.

• Audit & Review Readiness: Elevate the quality of documentation and narratives for formal review boards and external audits, ensuring clarity and compliance.

• Process Optimization: Lead initiatives to streamline investigation workflows and reduce complexity, enabling timely resolution of high-impact issues.

• Risk-Based Prioritization: Implement governance for prioritizing investigations based on business impact and compliance risk, ensuring timely escalation to senior leadership.

• Cross-Functional Collaboration: Act as a key partner to site leadership and business unit directors, aligning quality strategies with operational and regulatory objectives.

how to succeed

This role requires a senior professional with strong leadership presence, deep expertise in quality systems, and the ability to influence at all levels of the organization.

• Expert Investigative Skills: Extensive experience in leading and reviewing complex quality investigations (NC, Deviations, CAPA) within a GMP-regulated environment (Biopharma/Biotech).

• Master of Root Cause Analysis (RCA): Deep expertise in advanced RCA methodologies with a proven ability to move teams beyond "human error" to identify true systemic failures.

• QMS Subject Matter Expert: Strong command of Quality Management Systems and the ability to interpret regulatory requirements into practical, lean operational processes.

• Inspection Readiness: Proven track record of preparing documentation for and participating in regulatory inspections (e.g., EMA, FDA), ensuring records stand up to rigorous external scrutiny.

• Technical Mentorship: A passion for coaching; specifically the ability to upskill Quality Engineers and Operations staff on technical writing and investigation techniques.

• Cross-Functional Influence: Ability to "connect the dots" between the Quality organization and the Operations team (who sit outside of Quality), fostering a shared ownership of compliance.

• Senior Presence: Confident in reporting to Senior Management, translating complex quality data into clear risk-based insights and strategic recommendations.

• Process Optimization: Demonstrated success in streamlining workflows to reduce complexity while maintaining (or improving) the integrity of the records.

• Risk-Based Prioritization: Ability to design and implement frameworks that help the team prioritize investigations based on business impact and patient safety.

• Strategic Collaboration: A natural partner who can align site-level operations with broader corporate quality objectives.

benefits

This role offers a very competitive hourly rate. This contract will run for 6 months

you are welcome here

Johnson & Johnson Innovative Medicine 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. 

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”.