Qualified Person

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.

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Job 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.

The Qualified Person provides QA support to the commercial and/or clinical Advanced Therapy (AT) products manufactured at the Sassenheim manufacturing site. Provides Quality oversight to the manufacture of API (Lentiviral) for commercial and clinical use and to the IPC, release and stability testing of AT products tested at the Leiden QC department. Provides independent reviews and ensure that a clear, pragmatic and quality driven advice is given regarding the state of GMP compliance. The Qualified Person works in close collaboration with other departments (e,g, Operations, QC, MSAT, Engineering, Warehouse and Development Departments). Reports to Sr. Manager QA and works together with and coaches QA specialists. Other internal contacts include colleagues, both at operational and managerial levels, and all departments within manufacturing site. External contacts: Quality and Non-Quality representatives within the Janssen Supply Chain (JSC) companies.

Essential Job Duties and Responsibilities

• Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral) at the site
• Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations. Assesses non-conformances for possible impact on product quality or compliance status and decide on product disposition (e.g., Harvest, Intermediates, (P)FB or Drug Substances).
• Escalates serious quality, compliance and /or GMP incidents to Site or Global Management
• Setup and coordinate Site and Global escalation meetings
• Provides Quality support for the development of appropriate Corrective and Preventative actions and provides Quality approval
• Ensures that the local Non-Conformance and CAPA programs are improved with gaining knowledge from the process
• Support (Global) escalation of issues, which have potential impact on the delivery of products to patients
• Participates in risk assessments to ensure compliance or quality is not jeopardized
• Coordinates, reviews, and provides GMP training (e.g., Non-conformances, Investigation techniques, CAPA etc.) for site colleagues to ensure compliance to cGMP and company training requirements.
• Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and laboratories
• Provides review and approval of document changes and change controls
• Optimize current and identify new ways of process and quality monitoring
• Acts as quality SME and participates in the preparations for (APR, Inspection readiness reports) and during inspections (FDA, EMA etc.) to accomplish a successful audit.
• Perform level assessment, review, and approval of (deviation related) change controls.
• Partners with site colleagues to ensure all site changes (e.g., to production processes, equipment, and systems) are conducted in a controlled and systematic manner and conform to cGMP and other regulatory requirements.

Additional Duties & Responsibilities Qualified Person:

• Leads and supports facility in identifying and eliminating compliance risks.
• Acts as a quality representative and provide expertise to manage and participate in JBV projects to ensure compliance to cGMP and company quality requirements.
• Assesses, reviews, and approves study protocols and reports to assure that studies will be executed in a controlled and systematic manner conform cGMP and regulatory requirements e.g., but not limited to stability, validation, analytical technical transfer
• Act as member in Quality Risk Management and /or root cause investigation sessions.

Releases Drug Substance lots manufactured (for global distribution). This includes commercial products, phase 1-3 clinical materials, process validation batches and batches for Emergency Use. This is also valid for intermediates shipped to other sites for further processing.

• Ensure safety, efficacy and quality of product released by JBV and to ensure compliance with
• undefined
• Approval of High Risk (Global) Change Controls. Represent site in the local change control
• undefined
• Acts as member of the CAPA Review Board
• Lead Quality escalations and communication of complex issues
• Acts as the Qualified Person and SME at the JBV site during inspections by Health Authorities
• Partner in the Quality Systems Management Review
• Reviews and approves critical quality documents
• Represents QA in Global projects

Minimum education required for the position

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
• Represents QA in Global projects
• Experience in methods such as Process Excellence, Co Think or Kepner-Tregoe is recommended.

Other Requirements

• Proven knowledge of the biotechnological/lentiviral/pharmaceutical industry
• Proficiency in English both in word and in writing
• Deep understanding and application of Global Regulatory (cGMP/ICH/FDA/EMA) guidelines in Operations environment.
• Functions independently in a complex environment to make daily judgment to balance business need, regulatory requirements, and cost efficiency for all Quality decisions. Is required to determine the level of risk, magnitude and/or complexity in order to make sound judgment on when to escalate critical issues to Quality management.
• Broad knowledge of QA systems (i.e., change control, deviation management, cGMP, validation) manufacturing and laboratory processes, facilities and utilities and technical automation.
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues.
• Ability to drive collaboration in a fast-paced environment
• Problem solving and troubleshooting to initiate fresh, innovative, and compliant solutions to manage unexpected quality issues.
• Empowered professional who can make well motivated pragmatic decisions on their own.

The expected gross base salary for this role is between 88.400 EUR - 119.600 EUR, and includes 8% holiday allowance.”

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