(Experienced) Specialist QA – 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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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for (Experienced) Specialist QA Quality Systems Compliance to be based in Leiden.

The purpose of this role is to ensure a professional up to date high quality level of JBVs core Quality Systems and its applicationof these systems to maintain and improve the compliance status of JBVs processes and systems inline with the regulatory JBV Janssen Supply Chain and J&J standards. To develop and updates qualitysystems and procedures when appropriate. To advise Q&C Management and the executingdepartments regarding compliance issues and ensure resolution.

As an (Experienced) Specialist QA Quality Systems Compliance you will:

• Act as a Center of Expertise for GMP core quality systems. Maintains and improves GMP corequality systems ensuring that the JBV quality systems are compliant state-of-the-art andefficient.

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

• Have an outstanding knowledge of GMP regulations Janssen and J&J standards and translatesthese requirements in JBV systems that are compliant.

• Be responsible for the Inspection Readiness program for the quality systems under yourresponsibility ensuring that JBV is in compliance with the GMP regulations and has a high FirstTime Pass for all regulatory inspections.

• Perform internal audits as a (lead/team) auditor.

• Identify critical areas for improvementthrough audits and assessments and prioritize and execute the compliance improvementsinitiatives resulting from this.

• Use appropriate assessment tools (e.g. PE Lean Risk Management principles) in assessingthe status of current quality processes and in introducing improvements.

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

• Define the skill requirements and develops GMP training programs on quality systems for JBVemployees. Ensure that appropriate GMP training is given on these systems.

• Act as Quality contact for core quality systems in the JBV organization and internationally (JSCJ&J Regulatory Agencies 3rd Party). Ensure that JBV needs and requirements are wellpositioned.

• Maintain a relevant network of contacts with compliance specialists within JBV JSC and J&Jcompanies but also with other pharmaceutical companies and professional associationswhich will allow him/her to identify best practices for various quality systems.

• Ensure good communication with all departments and functional groups within JBV involvedin GMP work. Ensure that JBV management stays adequately informed.

• Ensure that performance quality and compliance reviews are made followed up and sharedwith upper management.

In addition to the responsibilities outlined above (which are also applicable to the standardGMP compliance specialist role) an (Experienced) Specialist QA - Quality Systems Compliance willhave the following responsibilities:

• Acts as a major contact for quality systems questions during regulatory inspections and 3rd Party audits.

• Advises management on major quality systems related issues and communicates recentdevelopments with regards to standards and cGMP in his/her area.

• Is responsible for all project aspects of GMP improvement initiatives carried out under thejobholders responsibility such as quality planning budget and communication.

Qualifications/Requirements:

Minimum education required:

External:

• Masters degree or equivalent in bioscience pharmacy or other related field;supplemented with additional training during work life.

• Extensive knowledge of Quality Systems in a cGMP environment

• Advanced courses on cGMP

Internal:

• Preferable: Process Excellence/Lean belt Risk Management and Auditing experience

Minimum experience required:

• Pharmaceutical or related industry work experience for 8-10 years of which a substantial part in quality or compliance functions.

• Experience in a complex multinational work environment/company

• Analytical innovative and pragmatic thinking.

• Proven leadership skills in a professional environment including coaching or supervisingmultidisciplinary teams.

• Excellent communicational and advisory skills result oriented.

• Excellent reporting skills.

Heres what you can expect:

• Application review:Well carefully review your CV to see how your skills and experience align with the role.

• Getting to know you:If theres a good match youll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.

• Staying informed:We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

• Final steps:For successful candidates you will need to complete country-specific checks before starting your new role. We will help guide you through these.

Finally at the end of the process well invite you to share feedback in a short survey your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

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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.