Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.
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.
Job Function:
QualityJob Sub Function:
Quality SystemsJob Category:
ProfessionalAll Job Posting Locations:
Leiden, NetherlandsJob Description:
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 https://www.jnj.com/innovative-medicine
We 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 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. To develop and updates quality systems and procedures when appropriate. To advise Q&C Management and the executing departments 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 core quality systems, ensuring that the JBV quality systems are compliant, state-of-the-art, and efficient.
Ensure consistency in the quality systems across processes and departments.
Have an outstanding knowledge of GMP regulations, Janssen and J&J standards and translates these requirements in JBV systems that are compliant.
Be responsible for the Inspection Readiness program for the quality systems under your responsibility ensuring that JBV is in compliance with the GMP regulations and has a high First Time Pass for all regulatory inspections.
Perform internal audits as a (lead/team) auditor.
Identify critical areas for improvement through audits and assessments and prioritize and execute the compliance improvements initiatives resulting from this.
Use appropriate assessment tools (e.g., PE, Lean, Risk Management principles) in assessing the 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 JBV employees. Ensure that appropriate GMP training is given on these systems.
Act as Quality contact for core quality systems in the JBV organization and internationally (JSC, J&J, Regulatory Agencies, 3rd Party). Ensure that JBV needs, and requirements are well positioned.
Maintain a relevant network of contacts with compliance specialists within JBV, JSC and J&J companies, but also with other pharmaceutical companies and professional associations, which will allow him/her to identify best practices for various quality systems.
Ensure good communication with all departments and functional groups within JBV involved in GMP work. Ensure that JBV management stays adequately informed.
Ensure that performance, quality, and compliance reviews are made, followed up and shared with upper management.
In addition to the responsibilities outlined above (which are also applicable to the standard GMP compliance specialist role), an (Experienced) Specialist QA - Quality Systems Compliance will have 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 recent developments with regards to standards and cGMP in his/her area.
Is responsible for all project aspects of GMP improvement initiatives carried out under the jobholder’s responsibility, such as quality, planning, budget, and communication.
Qualifications/Requirements:
Minimum education required:
External:
Master’s 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 supervising multidisciplinary teams.
Excellent communicational and advisory skills, result oriented.
Excellent reporting skills.
Here’s what you can expect:
Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If there’s a good match, you’ll 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, we’ll 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. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
#LI_Onsite
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Execution Focus, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People