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- Tasks: Lead investigations ensuring product quality and safety in a global healthcare setting.
- Company: Join Johnson & Johnson, a leader in innovative medicine and healthcare.
- Benefits: Competitive hourly rate, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact on patient well-being while developing your expertise in quality assurance.
- Qualifications: BA/BS in Science or Engineering with 7+ years in the Pharmaceutical Industry.
- Other info: Dynamic work environment with a focus on diversity, equity, and inclusion.
The predicted salary is between 45000 - 63000 ÂŁ per year.
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 endâtoâend 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 problemâsolving methodologies (Fishbone, 5 Whys, etc.) for all Product & Signal investigations.
- CrossâFunctional 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 expertâlevel 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 upâtoâdate, inâdepth 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 winâwin 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: 3â4 years of experience within Clinical R&D and/or Quality Assurance.
- Analytical Rigor: Strong critical thinking, leadership skills, and structured problemâsolving 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 scienceâbased 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 â 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: MidâSenior level
Employment type: Contract
Job function: Quality Assurance, Product Management, and Strategy/Planning
Industries: Hospitals and Health Care, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
Complaint Investigation Manager in London employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Complaint Investigation Manager in London
â¨Tip Number 1
Network like a pro! Reach out to your connections in the healthcare and pharmaceutical sectors. Attend industry events or webinars, and donât be shy about introducing yourself. You never know who might have the inside scoop on job openings!
â¨Tip Number 2
Prepare for interviews by practising common questions related to complaint investigations and root cause analysis. Use the STAR method (Situation, Task, Action, Result) to structure your answers. This will help you showcase your expertise and problem-solving skills effectively.
â¨Tip Number 3
Showcase your knowledge of regulatory compliance and quality assurance during interviews. Brush up on relevant legislation and be ready to discuss how you've applied this knowledge in past roles. This will demonstrate your commitment to maintaining high standards in the industry.
â¨Tip Number 4
Donât forget to apply through our website! Itâs the best way to ensure your application gets seen by the right people. Plus, it shows youâre serious about joining the team and makes it easier for us to keep track of your application.
We think you need these skills to ace Complaint Investigation Manager in London
Some tips for your application đŤĄ
Tailor Your Application: Make sure to customise your CV and cover letter for the Complaint Investigation Manager role. Highlight your relevant experience in complaint investigations and quality assurance, showing us how you meet the specific requirements mentioned in the job description.
Showcase Your Expertise: We want to see your knowledge shine through! Use examples from your past work to demonstrate your expertise in root cause analysis and regulatory compliance. This is your chance to show us how you can lead investigations effectively.
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate a well-structured application that makes it easy for us to see your qualifications and fit for the role.
Apply Through Our Website: Donât forget to submit your application through our official website! This ensures that we receive your application directly and can process it quickly. Plus, itâs the best way to stay updated on your application status.
How to prepare for a job interview at Johnson & Johnson
â¨Know Your Regulations
Make sure you brush up on relevant pharmaceutical legislation and cGMP regulations. Being able to discuss these confidently will show that youâre not just familiar with the industry but also serious about compliance, which is crucial for a Complaint Investigation Manager.
â¨Master Root Cause Analysis
Familiarise yourself with structured problem-solving methodologies like Fishbone and 5 Whys. Be prepared to discuss how you've applied these techniques in past roles, as this will demonstrate your analytical rigor and ability to lead investigations effectively.
â¨Showcase Your Communication Skills
Since this role involves cross-functional collaboration, practice articulating your thoughts clearly. Think of examples where youâve successfully negotiated or communicated complex information to stakeholders, as this will highlight your excellent verbal and written skills.
â¨Demonstrate Your Operational Skills
Be ready to talk about your time management strategies and how you maintain high-quality standards in a dynamic environment. Sharing specific instances where youâve managed multiple priorities will illustrate your commitment to quality and operational excellence.
