Experienced Specialist Quality Systems & Compliance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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We are searching for the best talent for anExperienced Specialist Quality Systems & Compliance.

Purpose

We are looking for an Experienced Specialist Quality Systems & Compliance to join the Advanced Therapies Lentiviral Operations site in Sassenheim the Netherlands.

Are you interested in helping strengthen quality systems and compliance processes that support the delivery of advanced therapies to patients

In this role you will support the execution and continuous improvement of core Quality Systems and Compliance activities across the site. Working closely with Quality Assurance Operations Quality Control Technical Operations and business partners you will help ensure quality systems are effective consistently executed inspection ready and aligned with GMP regulations Johnson & Johnson standards and site procedures.

This position plays an important role in quality planning management review performance monitoring risk management inspection commitments and quality system governance across the site.

You will be responsible for

In this role you will contribute to Quality Systems and Compliance activities for the Advanced Therapies Lentiviral Operations site. You will help maintain visibility of site quality performance support regulatory commitments and ensure governance processes are completed in a timely and consistent manner.

Working closely with Quality Assurance Operations Quality Control Technical Operations and site leadership you will facilitate management review activities maintain quality metrics support risk management processes and help ensure quality systems remain aligned with regulatory requirements and company standards.

You will also contribute to audit and inspection activities maintenance of site quality documentation and management of quality system records. Through collaboration with cross-functional teams you will help communicate compliance status identify risks monitor commitments and support timely completion of actions.

Key responsibilities include:

• Managing quality metrics and reporting activities for tier meetings management reviews review boards and other site governance forums
• Facilitating Management Review Board activities including preparation of presentations meeting inputs minutes actions extensions and follow-up activities
• Maintaining the Site Risk Register including risk reporting meeting preparation action tracking and escalation of overdue or high-priority actions
• Managing compliance tracking activities including inspection records commitments effectiveness checks audit observations and follow-up actions
• Supporting Site Quality Plan execution and tracking of commitments and related actions
• Supporting audit and inspection readiness activities including inspection management support
• Coordinating periodic updates of the Site Master File Quality Agreements and related compliance documentation
• Acting as owner or reviewer for nonconformance CAPA change control and other quality records within the assigned scope
• Supporting Data Integrity and Data Governance Plan activities
• Communicating metric trends action status compliance risks and procedural updates to management and business partners

This role also supports processes related to Quality performance metrics Tier governance Management Review Boards Quality Risk Management Site Quality Planning Data Integrity CAPA governance and inspection readiness activities.

Requirements

We are looking for someone who combines strong quality systems knowledge with excellent organizational communication and analytical skills.

Education

• Masters degree or equivalent in Bioscience Pharmacy Biotechnology Life Sciences Engineering Quality Regulatory Compliance or another relevant field
• Bachelors degree with significant relevant experience may also be considered

Experience

• Typically 5 years of experience within the pharmaceutical biotechnology MedTech or another regulated industry
• Experience in Quality Systems Compliance Quality Assurance Inspection Readiness or related quality functions
• Experience supporting or leading quality system processes such as nonconformance management CAPA change control quality management review quality planning risk management audit management data integrity or inspection readiness
• Experience working in a complex cross-functional and multinational environment with multiple partners and recurring governance forums
• Experience compiling quality metrics preparing management review packages tracking actions and communicating compliance status to management
• Experience with quality system applications and electronic record systems used for NC/CAPA change control commitments training document management metrics and quality records

Skills

• Knowledge of GMP quality systems and applicable regulatory expectations for pharmaceutical biotechnology ATMP or related regulated environments
• Strong execution focus with the ability to manage recurring activities audit commitments inspections and multiple priorities
• Excellent communication collaboration and collaborator engagement skills
• Strong analytical pragmatic and risk-based thinking
• Ability to identify risks maintain action follow-up discipline and escalate effectively when required
• Ability to compile analyze and present quality metrics trends action status and compliance topics in a clear and management-ready format
• Working knowledge of GMP regulations quality management systems documentation practices and inspection readiness expectations
• Ability to act as a quality systems contact during audits inspections and compliance reviews within the assigned scope
• Strong organizational skills with attention to detail accurate record management and timely completion of commitments
• Proficiency with Microsoft Office applications including Excel PowerPoint and Word
• Experience with Excel reporting PowerPoint presentations and quality system applications is preferred

Preferred Qualifications

• Additional training or certification in cGMP auditing Quality Risk Management Lean Process Excellence Six Sigma or related quality improvement methodologies
• Demonstrates an understanding of AI concepts and frameworks including awareness of responsible and ethical AI practices and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative environment where learning innovation and professional development are encouraged. You will have opportunities to work with experienced colleagues contribute to meaningful quality initiatives and support advanced therapy products that make a difference for patients.

Additional role information

• Location: Sassenheim The Netherlands

Our commitment to inclusion

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds experiences and perspectives.

We are proud to be an equal opportunity employer and welcome applications from all qualified candidates. Employment decisions are made without regard to legally protected characteristics.

If you require a reasonable accommodation during the application interview or onboarding process support is available. Please let us know how we can help.

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Required Skills:

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.