Senior External Quality Assurance Specialist

Biopharma Asia; Basel; Hybrid; CHF 110,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Specialist for External Quality in Switzerland, focusing on synthetic drug products manufactured externally. You will ensure compliance with cGMP, ICH and regulatory commitments, guiding quality activities and risk-based decisions with external manufacturers and partners.

You will support life-cycle management, audits, and technology transfer while driving continuous improvement across external quality processes and documentation practices to

Qualifications

• 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.

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 escal...
• 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.

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)

Education

Bachelor’s degree in Pharmacy, Science, Engineering or related

Tools

Microsoft Office

Quality system tools

Job description

Johnson & Johnson is seeking a Senior Quality Specialist for External Quality in Switzerland, focusing on synthetic drug products manufactured externally. You will ensure compliance with cGMP, ICH and regulatory commitments, guiding quality activities and risk-based decisions with external manufacturers and partners.

You will support life-cycle management, audits, and technology transfer while driving continuous improvement across external quality processes and documentation practices to