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- Tasks: Drive a culture of quality and oversee compliance in clinical operations.
- Company: Join a leading organisation focused on innovative healthcare solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to lead and influence quality initiatives.
- Why this job: Make a real impact on quality in clinical research and development.
- Qualifications: 2-5 years in clinical operations or quality, with knowledge of GCP regulations.
The predicted salary is between 50000 - 65000 £ per year.
You will be responsible for driving a culture of quality within GCO and will serve as an advocate for the Quality Management System (QMS). As the Functional Quality Representative (FQR) for GCO, you will be liaising with the R&D Quality / Compliance team and other FQRs operating within the defined quality governance structure. You will provide leadership and expertise for investigations of potential or actual quality issues pertaining to GCP, and escalate as necessary per the quality governance pathway. In consultation with GCO stakeholders, you will determine the overall risk for quality issues, and facilitate the execution of Corrective and Preventative Actions (CAPAs) as required, including the evaluation of the adequacy of the CAPAs / Effectiveness Checks.
Accountabilities:
- Supporting the maintenance and development of the QMS by:
- Reviewing GCO process deviations for compliance and completeness.
- Participating in process improvements and functional initiatives, as required.
- Reviewing and assessing controlled documents for possible gaps with respect to quality, compliance and regulatory commitments.
- Engaging with Process Owners / Sub-Process Owners or functional area leads to review Key Quality Indicators/ tolerance thresholds and communicate quality and compliance risks.
- By identifying process / functional risks and issues and mitigation strategies, determine requirements for escalation and communication to functional/quality leadership.
- Providing consultation on quality questions / issues for programs and studies.
- Monitoring functional metrics to assess compliance with processes and procedures and evaluating for potential quality signals / trends.
- Implementing quality process reviews as needed.
- Overseeing and approving CAPAs / Effectiveness checks.
- Acting as quality liaison with vendor quality representatives as needed.
- Contributing to audit planning and management of audit responses.
- Conducting site and sponsor inspection preparation for GCO, identifying key risks and mitigation strategies, coordinating site inspection management activities, and facilitating inspection responses as appropriate.
Qualifications:
- 2-5 years’ experience in clinical operations and / or compliance or quality function or equivalent.
- In depth understanding of GCP and global regulations and standards that govern the development of clinical products (CFR, ICH, EU Directives).
As Manager, Clinical Operations Quality Oversight, you will provide quality oversight of activities executed within Global Clinical Operations (GCO), including studies, programs and processes. In addition, you will contribute to GCO audit / inspection planning, management and response generation.
Manager, Quality Operational Capabilities in Maidenhead employer: Biogen SANDBOX
Contact Detail:
Biogen SANDBOX Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Quality Operational Capabilities in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working in quality management roles. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP and quality management systems. We recommend practising common interview questions and scenarios related to quality oversight to show you’re the right fit.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you and match your skills in quality operational capabilities.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind and show your enthusiasm for the role. Plus, it’s a great chance to reiterate why you’d be perfect for the job.
We think you need these skills to ace Manager, Quality Operational Capabilities in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experience that match the job description. Highlight your experience in quality management and compliance, as well as any relevant achievements in clinical operations.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about quality in clinical operations. Share specific examples of how you've driven quality initiatives or resolved compliance issues in the past.
Showcase Your Leadership Skills: As a Manager, we want to see your leadership capabilities. Mention any experiences where you led a team or project, especially in relation to quality management systems or CAPA processes.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows your enthusiasm for joining our team!
How to prepare for a job interview at Biogen SANDBOX
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of Quality Management Systems (QMS) and Good Clinical Practice (GCP). Be ready to discuss how you've previously contributed to maintaining or improving quality standards in your past roles. This will show that you understand the importance of quality in clinical operations.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific quality issues or compliance challenges. Think of examples from your experience where you identified risks, implemented Corrective and Preventative Actions (CAPAs), or improved processes. Having these scenarios ready will demonstrate your problem-solving skills.
✨Familiarise Yourself with Regulatory Standards
Since the role involves understanding global regulations and standards, make sure you're well-versed in CFR, ICH, and EU Directives. You might be asked about how these regulations impact quality management, so being able to articulate this clearly will set you apart.
✨Engage with the Interviewers
During the interview, don’t just answer questions—engage with your interviewers. Ask them about their current quality initiatives or challenges they face within GCO. This shows your genuine interest in the role and helps you gauge if the company culture aligns with your values.