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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 (Masterâs 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 England 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 England
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 fit for the Complaint Investigation Manager position.
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 our team and contributing to our mission in healthcare.
We think you need these skills to ace Complaint Investigation Manager in England
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 GXP, root cause analysis, and regulatory compliance. This will help us understand how you can contribute to our team.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key achievements stand out. This makes it easier for us to see your potential fit for the role.
Apply Through Our Website: Donât forget to submit your application through our official website! This helps us track your application efficiently and ensures youâre considered for the role without any hiccups.
How to prepare for a job interview at Johnson & Johnson
â¨Know Your Stuff
Make sure you brush up on your knowledge of pharmaceutical regulations and quality compliance. Familiarise yourself with relevant legislation like Eudralex and ICH, as well as the specific complaint investigation processes. This will show that you're not just a candidate, but a potential expert in the field.
â¨Showcase Your Problem-Solving Skills
Be prepared to discuss your experience with structured problem-solving methodologies like Fishbone and 5 Whys. Have examples ready that demonstrate how you've successfully led investigations and resolved issues in the past. This will highlight your analytical rigor and critical thinking abilities.
â¨Communicate Effectively
Since this role involves cross-functional collaboration, practice articulating your thoughts clearly and concisely. Think about how you can convey complex information to different stakeholders, and be ready to showcase your negotiation skills during the interview.
â¨Demonstrate Your Commitment to Quality
Highlight your operational skills and commitment to quality throughout the interview. Share examples of how you've managed timelines and prioritised deliverables in dynamic environments. This will reassure them that you can handle the demands of the role while maintaining high standards.
