Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

Professional

All Job Posting Locations

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy

Job Description

J&J; Innovative Medicine is recruiting for a Senior Specialist External Quality to be located in Latina (IT), Beerse (BE) or Allschwil (CH). This role will report to the Sr. Manager External Quality. 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

- 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 elevate 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 commitments, including preparation, response review and follow-up of agreed actions.
- Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products.
- Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders.

Minimum Qualification

- Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline.
- Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D; or a related pharmaceutical and/or biotechnology environment.
- Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply.
- Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations.
- Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making.
- Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners.
- Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and maintain a collaborative and professional approach.
- Excellent computer proficiency,



including Microsoft Office and standard quality system tools.
- Experience with deviation, CAPA, change control, complaint, batch release, quality agreement, audit or inspection support processes.

Preferred Qualification

- Experience working with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners.
- Experience working on cross-functional project teams.
- Experience with product transfer, new product introduction, parenteral, and/or combination products.

Other

This role may require up to 25% of domestic & international travel.

Required Skills

Quality Standards

Preferred Skills

- Communication, ISO 9001, Issue Escalation

Benefits

- an annual premio with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- vacation days
- parental leave for a minimum of 12 weeks
- bereavement leave
- caregiver leave
- volunteer leave
- well-being reimbursement
- programs for financial, physical and mental health
- service anniversary and recognition awards
- subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

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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📌 Senior Specialist External Quality (Borgo San Michele)
🏢 7175-Janssen Cilag S.p.A. Legal Entity
📍 Borgo San Michele