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- Tasks: Lead IT compliance in a dynamic pharmaceutical environment, focusing on advanced systems and regulatory audits.
- Company: Join 4basebio, a pioneering biotech firm dedicated to innovation and compliance in the pharmaceutical sector.
- Benefits: Enjoy competitive salary, private healthcare, pension contributions, and life assurance.
- Why this job: Be at the forefront of tech advancements like AI while making a real impact in healthcare.
- Qualifications: Bachelor's degree in IT or related field; experience in GxP environments is essential.
- Other info: Located in Swavesey, Cambridge; must have the right to work in the UK.
The predicted salary is between 36000 - 60000 £ per year.
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The IT Compliance Lead will be responsible for overseeing the implementation and management of compliant systems within the company. The ideal candidate will have a proven track record in implementing and managing advanced IT systems within a pharmaceutical environment. The role will focus on new technological advancements (including Artificial Intelligence and Large Language Models), managing existing systems, maintaining the compliance, supporting various regulatory and customer audits etc. this role requires a deep understanding of pharmaceutical regulatory requirements and the ability to lead/support various projects, including electronic Quality Management System (EQMS) implementation, Laboratory Investigation Management System (LIMS) and Electronic Batch Manufacturing Record (EBMR) implementation etc. The IT Lead will also handle generic IT roles and responsibilities, with a focus on the specific needs of the pharmaceutical sector.
Responsibilities:
- Implementing Compliant Systems: Ensure all IT systems comply with industry regulations and standards, including data integrity controls as specified from GxP, GAMP, FDA, MHRA, and other relevant guidelines.
- Managing Existing Systems: Oversee the maintenance and optimisation of current IT infrastructure, ensuring seamless operation and compliance.
- Project Support: Lead and support projects such as electronic QMS implementation, electronic batch manufacturing record implementation, laboratory investigation management system and other IT initiatives aimed at improving operational efficiency and compliance.
- IT Governance: Develop and enforce IT policies and procedures to ensure data integrity, security, and compliance.
- Vendor Management: Collaborate with external vendors to procure and manage IT solutions that meet the specific needs of the pharmaceutical industry.
- Training and Development: Provide training and support to staff on new systems and technologies, ensuring they are equipped to meet regulatory requirements.
- Technical Support: Offer technical support and troubleshooting for IT-related issues, ensuring minimal disruption to operations.
- Software Qualification: Lead and support on technical & software system qualification and ongoing compliance activities.
- Innovation and Improvement: Stay updated with the latest industry trends and technologies, recommending and implementing improvements to enhance IT capabilities.
- Cybersecurity Management: Develop and implement cybersecurity strategies to protect sensitive data and IT infrastructure from cyber threats. Ensure compliance with cybersecurity regulations and standards.
- Risk Assessment: Conduct regular risk assessments to identify vulnerabilities and implement measures to mitigate potential threats.
- Incident Response: Establish and maintain an incident response plan to address and manage cybersecurity incidents effectively.
- Audit Management: Timely support on managing the regulatory inspections, client audits to ensure the IT systems and compliance are sufficiently represented.
- Automation: Explore, propose, implement and project manage/support various automation projects as per the management intention.
Person Specification:
- Experience of working in a GxP environment within Pharmaceutical or similar industry.
- Excellent interpersonal skills, organised, efficient and motivated self-starter
- Problem solver with excellent attention to detail
- Bachelor’s degree in information technology, Computer Science, or a related field; advanced degree preferred.
- Extensive experience in the pharmaceutical industry, with a focus on IT systems implementation, management and GXP compliance
- Expertise in cybersecurity management and risk assessment.
- Strong knowledge of Electronic Pharmaceutical Quality Systems (EPQS), Laboratory Investigation Management Systems (LIMS), and Electronic Batch Manufacturing Records (EBMR).
- Excellent problem-solving skills and the ability to work under pressure.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
- Proven leadership experience, with a track record of managing and developing high-performing IT teams.
- Must have the right to work in the UK.
What we can offer: Competitive salary + private healthcare + pension contributions + life assurance
Location: Swavesey, Cambridge
To apply for this role send you CV and covering letter to Recruitment@4basebio.com
Due to the high number of applicants, if you do not hear back from us within 6 weeks, we thank you for your interest, but please assume you have not been selected for interview on this occasion.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Information Technology
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Industries
Biotechnology
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IT Compliance Lead employer: 4basebio
Contact Detail:
4basebio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IT Compliance Lead
✨Tip Number 1
Familiarise yourself with the latest pharmaceutical regulations and compliance standards, especially GxP and FDA guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the pharmaceutical IT sector. Attend industry events or join relevant online forums to connect with others who can provide insights or even referrals for the position.
✨Tip Number 3
Stay updated on technological advancements, particularly in AI and cybersecurity. Being able to discuss recent trends and how they apply to compliance in the pharmaceutical industry can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific projects you've led or contributed to that involved IT systems implementation in a GxP environment. Highlighting your hands-on experience will showcase your capability to handle the responsibilities of the IT Compliance Lead.
We think you need these skills to ace IT Compliance Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in IT compliance, particularly within the pharmaceutical sector. Emphasise your familiarity with GxP, GAMP, FDA, and MHRA regulations, as well as any specific projects you've led or contributed to.
Craft a Compelling Cover Letter: In your cover letter, explain why you're passionate about IT compliance in the pharmaceutical industry. Mention specific technologies or systems you've worked with, such as EQMS, LIMS, or EBMR, and how they relate to the role.
Showcase Leadership Skills: Highlight your leadership experience in managing IT teams or projects. Provide examples of how you've successfully led initiatives that improved compliance or operational efficiency, as this is crucial for the IT Compliance Lead role.
Demonstrate Problem-Solving Abilities: Include examples in your application that showcase your problem-solving skills, especially in high-pressure situations. Discuss how you've addressed compliance challenges or implemented innovative solutions in past roles.
How to prepare for a job interview at 4basebio
✨Understand Regulatory Requirements
Make sure you have a solid grasp of the pharmaceutical regulatory landscape, including GxP, GAMP, FDA, and MHRA guidelines. Be prepared to discuss how your experience aligns with these regulations and how you've ensured compliance in past roles.
✨Showcase Your Project Management Skills
Highlight your experience in leading IT projects, especially those related to electronic Quality Management Systems (EQMS) or Laboratory Investigation Management Systems (LIMS). Be ready to provide specific examples of how you managed timelines, resources, and stakeholder communication.
✨Demonstrate Technical Expertise
Be prepared to discuss your technical knowledge, particularly in cybersecurity management and risk assessment. You might be asked about specific tools or methodologies you've used to protect sensitive data and ensure system integrity.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities and decision-making skills. Think of examples where you've had to troubleshoot IT issues or manage compliance challenges, and explain your thought process and outcomes.
