QA Specialist - GMP System Data Integrity

QA Specialist -  GMP System Data Integrity

Location: Leiden, Netherlands (Onsite working)

Duration: 12 months 

Hours: 40 

Imagine your next project driving high-quality performance and compliance standards across state-of-the-art biological systems in a dynamic, international healthcare environment.

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. Develops and updates quality systems and procedures when appropriate. Advises Q&C Management and the executing departments regarding compliance issues and ensures resolution.

The focus of the function is to ensure that the core quality systems at JBV meet the current industry and regulatory standards.

The complexity lies also in the fact that the jobholder operates in a complex, multi-functional, and multi- site environment, where continuous improvement of the core quality systems is required. The position requires a strong analytical and independent thinking and decision making to find structural and regulatory-wise sound solutions for issues identified. Especially in outside contacts, decisions and actions are occasionally reviewed.

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

Numerous contacts will be maintained within JBV, and at JSC, Home Office, J&J Corporate level but also with Regulatory Agencies and 3rd Parties. The jobholder is expected to resolve matters effectively even when interests are conflicting. The jobholder is able to negotiate a favorable solution for all parties involved. Outside contacts require tact and diplomacy.

roles and responsibilities

• Acts 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.

• 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.

• Is responsible for the Inspection Readiness program for the quality systems under their responsibility ensuring that JBV is in compliance with the GMP regulations and has a high First Time Pass for all regulatory inspections.

• Performs internal audits as a (lead/team) auditor. Identifies critical areas for improvement through audits and assessments and prioritizes and executes the compliance improvements initiatives resulting from this.

• 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.

• Defines the skill requirements and develops GMP training programs on quality systems for JBV employees. Ensures 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). Ensures that JBV needs, and requirements are well positioned.

• Maintains 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 them to identify best practices for various quality systems.

• 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.

• 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 their 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.

how to succeed

• 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 ie. Annex11

• Advanced courses on cGMP Internal

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

• 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.

• Fluency in English 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months 

you are welcome here

Johnson & Johnson 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

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

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 or LinkedIn InMail - you must apply direct to this advert.

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”.