Sr. Specialist External Quality

Johnson & Johnson Co.; Latina; On-site; EUR 70,000 - 90,000; Full time

Job summary

Johnson & Johnson in Latina, Italy is seeking a Senior Specialist, External Quality to ensure the highest quality and regulatory compliance for externally manufactured Synthetic drug products. You will partner with External Quality Site Leads, Product Quality and external partners to uphold cGMP, ICH standards and patient safety.

You will lead QA activities across manufacturing, packaging, testing, release and stability, reviewing deviations, CAPAs and quality agreements, and supporting audits

Qualifications

• Support externally manufactured Synthetic drug products in line with cGMP and ICH expectations.
• Provide QA oversight for external manufacturers handling drug substance/product lifecycle.
• Ensure compliance with J&J policies and regulatory commitments.

Responsibilities

• Provide QA support and oversight for external synthetic manufacturing operations.
• Review and approve deviations, CAPAs, change controls, investigations, and quality docs.
• Monitor performance using quality metrics, audits, and supplier data.
• Escalate quality or supply risks and support mitigation plans.
• Collaborate with cross-functional teams to meet patient supply needs.
• Support audits and regulatory inspections.

Skills

Quality Assurance

Regulatory Compliance

Risk Management

External Vendors Oversight

Cross-functional Collaboration

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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium R-109826, Italy R-109827, Switzerland R-109772

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Latina, Italy

Job Description

External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.

In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products, produced at external manufacturing sites. You'll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do!

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

This role supports business, quality and compliance objectives for externally manufactured Synthetic drug products, ensuring activities are performed in accordance with J&J policies, enterprise standards, quality agreements, cGMP requirements, ICH expectations and applicable regulatory commitments.

The Senior Specialist EQ provides quality assurance support and oversight for external manufacturers and strategic partners involved in Synthetic drug substance and/or drug product manufacturing, packaging, testing, release, stability and supply activities, while helping to maintain product quality, compliance and reliable patient supply.

Key Responsibilities

• Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
• Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
• Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
• Identify, communicate and escalation quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
• Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
• Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met.
• Support external manufacturers during J&J audits, health authority inspections and regulatory