Senior Specialist External Quality

7 giorni fa

Borgo San Michele, Lazio, Italia 7175-Janssen Cilag S.p.A. Legal Entity Tempo pieno

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Job Function

Quality

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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

Preferre

Senior Specialist External Quality

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