Are you ready to take on a unique and exciting opportunity as a Specialist QA – GMP Quality Systems Compliance? Johnson & Johnson is seeking a highly motivated individual to join our team in Leiden, Netherlands with an unlimited contract. This is your chance to be part of a world-class organization that is committed to innovation and delivering flawless quality in everything we do.

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 ensure resolution.

Essential Job Duties and Responsibilities GMP Specialist

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 his/her 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 him/her 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.

In addition to the responsibilities outlined above (which are also applicable to the standard GMP compliance specialist role), an Experienced Specialist QA - GMP 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.

Magnitude & Complexity

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 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.