Qualified Person (Mgr.)

7266-Janssen Biologics B.V. Legal Entity; Sassenheim; On-site; EUR 90,000 - 120,000; Full time

Job summary

Johnson & Johnson in Sassenheim seeks a Qualified Person to provide QA support for commercial and AT products, ensure GMP compliance, and collaborate with Operations, QC, and MSAT teams at the site.

The role includes reviewing investigations, initiating CAPAs, and supporting inspection readiness with cross-functional partners to uphold cGMP standards.

Qualifications

• QA professional with GMP knowledge and strong attention to cGMP.
• Experience in quality investigations and CAPA processes.
• Ability to lead audits and inspections (FDA, EMA).
• Collaborative with cross-functional manufacturing teams.

Responsibilities

• Provides Quality oversight to the production of Commercial and/or clinical AT Products (Lentiviral).
• Assesses non-conformances for impact on product quality and decides disposition.
• Escalates incidents to Site or Global Management and supports CAPA development.
• Participates in risk assessments and training for site colleagues.

Skills

Quality Assurance

GMP

CAPA

Root Cause

Audits

Job description

Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Sassenheim, Netherlands

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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