Sr Analyst, External Clinical Supply Quality

Job Description

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 Function: Quality Job Sub Function: Supplier Quality Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium, Latina, Italy, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland

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 Sr Analyst, External Clinical Supply Quality, role is responsible for the quality and compliance in the selection, qualification, monitoring and management for external suppliers used for the packaging, labeling, over‑encapsulation, and distribution of Investigational Medicinal products. Additionally, this individual will support continuous improvement for proactive quality and/or business needs.

Key Responsibilities

Supplier Management

• This position will serve as a Quality contact point for the External Manufacturer/Supplier with respect to the J&J product in the External Manufacturer facility.
• The position holder will have signatory authority for QA in those projects.
• Support or lead the qualification during selection and routine monitoring of suppliers via clinical audits.
• The position will negotiate, review, and approve all relevant Quality Agreements between J&J and the External Manufacturers.
• The position assures implementation of these Quality Agreement.
• Contributes to the overall development, implementation, and execution of quality systems in support of the external suppliers.
• Provide cGMP compliance support to suppliers by proactive management of quality using risk‑based approaches, and supporting the investigation of quality issues and product quality complaints.
• Drive phase appropriate GMP implementation at external packaging and label suppliers in early and late phase development to fulfill the business requirements.
• Builds relationships and collaborates with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
• Monitor trends, identify issues, recommend, and implement appropriate actions.
• Maintain and/or approve GMP documentation at suppliers and within Johnson and Johnson including but not limited to supplier account records, audit records, investigations, and CAPAs.

Project Management/Process Improvement

• Leads or serves in teams or major cross‑functional project initiatives to proactively improve quality/compliance or drive business goals.
• Develop, implement, review and/or approve SOPs associated with clinical packaging and labeling.

Batch Record Review

• Oversees the batch record review process and monitor the status of KPIs.
• Collaborates within Clinical Supply Chain to resolve batch record discrepancies or errors as it relates to Good Documentation Practices.
• Ensures that manipulated drug products and finished products produced for clinical trials are released in accordance with the cGMP and the product specification file and in a timely manner to prevent patient or trial impact.

General

• The position will serve as a contact point within the QA Organization for project leaders (i.e. from GCO/CSC) with respect to the Quality Organization’s activities related to introduction of new clinical products to External Manufacturers/Suppliers.
• The position will review