Sr. Specialist External Quality

Johnson & Johnson Co.; Borgo San Michele; On-site; EUR 49,000 - 78,000; Full time

Job summary

Johnson & Johnson is seeking a Quality professional to ensure external quality for synthetic drug products produced at external sites. You will collaborate with site leads and cross-functional teams to maintain high standards of quality, compliance, and patient safety across the supply chain.

The role emphasizes QA review of deviations, CAPAs, change controls, and regulatory commitments, with travel up to 25% and interaction with internal and external partners.

Qualifications

• Bachelor's degree or equivalent in Pharmacy, Science, Engineering or related field.
• 4+ years in quality management/quality assurance in pharma/biotech.
• Experience in GMP environments and external manufacturing quality support.

Responsibilities

• Provide QA oversight for external Synthetics manufacturing, packaging, testing, release and stability.
• Review deviations, CAPAs, change controls, investigations, and quality agreements.
• Monitor supplier performance and risk, ensure compliance with cGMP and ICH requirements.
• Support audits/inspections and technology transfer for external manufacturing partners.

Skills

Quality management

Regulatory compliance

Document control

CAPA

Audit support

SOPs

Education

Bachelor's degree in Pharmacy/Science/Engineering

Tools

Microsoft Office

Quality systems software

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: 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.

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 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

Business Alignment, 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)

Preferred Skills

Business Alignment, 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)

The anticipated base pay range for this position is: €49’100.00 - €78’200.00

Benefits

• an annual bonus 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.
• Moreover, we offer 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.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information: 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 https://www.jnj.com/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.