Sr Supervisor Quality Systems and Compliance for GMP Training

at  Johnson Johnson

Johnson & Johnson is currently seeking an

JOB SUMMARY:

The Sr. Supervisor Quality Systems and Compliance - GMP training is responsible for the management and delivery of GMP training to Janssen Biologics Leiden and is the Leiden (system) owner of Global Quality Systems that are used to manage and document the execution of quality processes in line with the company and regulatory standards and requirements. You work with the Global teams to ensure the fitness-for-use, roll out and performance of these (electronic) Quality Systems. You collaborate with all business unit stakeholders at the site to support them for the GMP training process.
As a supervisor you are also accountable for the personnel on your team, their performance and development.
Janssen Biologics Leiden Operations delivers key commercial Biotherapeutic products (API) like Remicade, Simponi and Stelara, but has also build a strong expertise in Vaccines and Viral vector production and testing activities. Currently the site is also starting the introduction of Gene Therapy Products.
Activities within the Quality Systems & compliance department comprise the full spectrum of Quality Systems within Janssen Biologics Leiden (e.g. GMP training, Doc management, Non-Conformances/CPA, Change control, Validation, Risk management, APR etc) to support all the site manufacturing and testing activities for Biologic and Advanced Therapy products.
The Sr. Supervisor is a member of the Quality Systems & Compliance Management team, and as such plays a major role in providing advice on Quality Systems to all departments, which are part of the Supply chain. The position provides a unique opportunity to work on the latest and future technologies in biopharmaceutical manufacturing, and you will become part of a worldwide network of Quality Systems experts within and beyond Janssen.
In addition, your personal leadership skills will be asked for, and will be further developed, in your continuous shaping and improving of the Quality System function.

REQUIRED QUALIFICATIONS AND COMPETENCES:

• Minimum of Bachelor degree in relevant discipline, e.g. biosciences, pharmacy, analytical chemistry, process technology or engineering.
• Minimum of 6 years experience in quality and/or similar GMP environment in pharmaceutical, consumer or medical device company.
• Experience in a (project) lead or people supervisory position is preferred
• Knowledge of current Quality Management principles, GMP and Quality Systems Pharma regulations.
• Team player, and ready to take a stand when necessary.
• Expertise in Computer systems and Innovative technology systems would be a plus.
• Good written and oral communication skills in Dutch and/or English

• Manages, leads & motivates the GMP training team (3-5 persons) to enhance performance and achieve business goals, agreed metrics & budgets
• Functions independently to make daily judgments to balance business need, regulatory requirements, continuous improvement and cost efficiency projects related to the GMP training activities and the performance of the electronic Quality Systems. Defines the long term strategy for the GMP training activities for the site in close collaboration with the business unit stakeholders and the global quality systems organization.
• Assess impact, risks and make immediate decisions regarding the departmental activities. In case of major quality events in the area of responsibility you are the primary adviser for the Sr manager QS&C and all business stakeholders at the site.
• Collaborates frequently with managers, supervisors/team leaders and operational levels across Janssen Biologics. The function requires good communication and influencing skills to ensure proper compliance levels and service to the organization.
• Acts as WW contact for the site in the area of responsibility. The person is able to negotiate a favorable solution for all parties involved, even when interests are colliding.
• Supports inspection readiness programs and manages the process during Quality Regulatory inspections.
• Replaces other Quality system team members, and the Sr manager QS&C when needed.