Sr. Specialist External Quality

Johnson & Johnson Co.; Latina; On-site; EUR 75,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking an External Quality Senior Specialist to ensure quality and compliance for externally manufactured synthetic drug products. You will collaborate with External Quality Site Leads and cross-functional teams to uphold cGMP standards and regulatory commitments.

You will contribute to continuous improvement, risk management, and lifecycle management of external manufacturers while supporting audits and technology transfer initiatives.

Qualifications

• Bachelor’s degree or equivalent in Pharmacy, Science, Engineering, or related technical discipline.
• Minimum 4 years in quality management, QA, production, QC, R&D, or related pharma/biotech environment.
• GMP-regulated environment experience; QA support for external manufacturing preferred.

Responsibilities

• Provide QA oversight for external synthetic drug products and supplier activities.
• Review and approve deviations, investigations, CAPAs, change controls, complaints and batch records.
• Monitor external manufacturers using quality metrics, audit outcomes, inspections, and supplier data.
• Identify and communicate quality or supply risks and support mitigation plans.
• Support qualification, monitoring, and lifecycle management of external manufacturers and partners.
• Collaborate with QA, MSAT, Planning, Regulatory, EHS, and external partners to ensure patient supply.
• Assist during audits/inspections and regulatory commitments, including preparation and action follow-up.
• Participate in technology transfer, product lifecycle management, and process improvement initiatives.
• Contribute to continuous improvement of External Quality processes and documentation practices.

Skills

Quality Assurance

Quality systems

Audit support

CAPA

Risk management

Documentation

Communication

Education

Bachelor’s degree

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.

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:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, 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.

• 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 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.

Preferred Skills

• AI Judgement Integration
• Business Alignment
• Business Savvy
• Coaching
• Communication
• Compliance Management
• Continuous Improvement
• Fact-Based Decision Making
• Human-Centered Design
• ISO 9001
• Issue Escalation
• Problem Solving
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment
• Standard Operating Procedure (SOP)