Complaint Investigation Manager

Location: Hybrid working (UK, Switzerland, Belgium, Netherlands, or Ireland only).

Duration: 12 months

Hours: 40 hours

Imagine your next role supporting a global healthcare leader by ensuring the highest standards of product quality and safety, leading complex investigations that directly impact patient well-being and regulatory compliance.

Roles and Responsibilities

• To provide expertise and timely proactive support for the investigation, documentation, and resolution of Product & Signal Complaint Investigations, Nonconformances, and CAPAs.
• Reporting to the Director of PQM Strategy Deployment & Excellence, you will act as a Subject Matter Expert (SME) to drive end‑to‑end accountability and root cause excellence.
• Process Leadership: Acting as the SME for complaint investigation processes, providing guidance on technical and quality compliance within the PQM Team.
• Investigation Management: Ensuring deviations and complaints are investigated thoroughly and timely to meet internal and external customer expectations.
• Root Cause Analysis (RCA): Leading the application of structured problem‑solving methodologies (Fishbone, 5 Whys, etc.) for all Product & Signal investigations.
• Cross‐Functional Collaboration: Working directly with Device Engineers and PQI/PQO teams to ensure deep product knowledge of Synthetics, Proteins, and Cell/Gene therapies is integrated into investigations.
• Compliance Monitoring: Running reports to monitor Nonconformance and CAPA deliverables, communicating deadlines to owners, and escalating concerns to management to drive compliance.
• System Proficiency: Developing and maintaining expert‑level proficiency in COMET and associated quality systems.
• Stakeholder Engagement: Identifying organizational resources to support RCA investigations and resulting actions while fostering a culture of critical thinking.
• Governance: Escalating issues to the PQM CAPA Review Board and attending meetings as a representative for functional area investigations.

Key Compliance Requirements

• Regulatory Knowledge: Maintain up‑to‑date, in‑depth understanding of relevant pharmaceutical legislation and cGMP regulations (Eudralex, ICH, Ph.Eur., USP, etc.) at global and regional levels.
• Safety Reporting: Ensure safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs are met and appropriately managed.
• Inspection Readiness: Ensure inspection readiness with respect to personal training compliance and availability of recent CV and individualized Job Description.
• Risk Management: Apply appropriate risk assessment strategies to manage business and compliance priorities and translate them into actionable plans.

Communication with Others

• Internal Partnerships: Managing effective relationships with all key stakeholders including Patient Access, Communications, Finance, Commercial, and Medical teams.
• Global Engagement: Driving engagement with relevant EMEA stakeholders to ensure alignment on investigation standards.
• Conflict Resolution: Utilising negotiation skills to create win‑win situations with internal and external partners.

Decision Making Autonomy

• Independent management of investigation timelines and prioritization of deliverables based on business needs.
• Authority to lead RCA methodologies and determine the adequacy of root cause documentation before closure.

How to Succeed

We are looking for candidates with a BA/BS in Science or Engineering (Master’s preferred) and a minimum of 7 years of Pharmaceutical Industry experience. You will also bring:

• GXP Expertise: 3‑4 years of experience within Clinical R&D and/or Quality Assurance.
• Analytical Rigor: Strong critical thinking, leadership skills, and structured problem‑solving expertise.
• Communication: Excellent verbal and written skills to negotiate and communicate with customers and partners.
• Operational Skills: High commitment to quality, excellent time management, and the ability to work in a dynamic, changing environment.
• Software Skills: Proficient in Microsoft Office applications and familiar with corporate quality systems.

This role offers a very competitive hourly rate. This contract will run for a minimum of 12 months.

You Are Welcome Here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson Innovative Medicine

Patients inform and inspire our science‑based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

Application Process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

Seniority level: Mid‑Senior level

Employment type: Contract

Job function: Quality Assurance, Product Management, and Strategy/Planning

Industries: Hospitals and Health Care, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing