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Job purpose:
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 [email protected]
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.
