IT Compliance Senior Manager – Biotech

We are recruiting for a IT Compliance Senior Manager for a growing Biotechnology company based in the UK. This is a fantastic opportunity for an experienced IT Compliance professional to step into a senior influential position within a well-funded and growing biotech with a bright future developing innovative therapeutic products.

Responsibilities

Regulatory Compliance Activities

• Accountable for Computer Systems Validation process and documentation to ensure compliance with regulatory frameworks throughout the IT asset lifecycle for regulated systems.
• Oversee the monitoring and periodic review of systems to ensure continuous compliance.
• Conduct necessary IT compliance control monitoring and testing activities to determine the effectiveness of the controls.
• Remediate IT compliance control deficiencies.
• Investigation and documentation of any incidents, breaches or unlawful activity related to IT compliance, such as the intentional release of privileged information or a related security breach.
• Actively support upkeep and maintenance IT compliance policies, based on any relevant regulatory changes or new laws.
• Partner closely with Quality Assurance function to identify all IT compliance requirements (i.e. security, user access, privacy, data integrity, etc.) associated with the laws and regulations within all relevant jurisdictions.

GDPR and Privacy Activities

• Guide third-party stakeholders (including business partners, suppliers, service providers and IT product vendors) to ensure that they clearly understand and comply with the company’s privacy requirements.
• Support the company’s GDPR requirements for DPIA, SARs, Breaches and Article 30.

General Compliance Activities

• Manage and update the Enterprise Risk Management log, addressing risks by initiating and overseeing appropriate mitigation projects. Experience with managing issues, incidents, CAPAs and deviations.
• Report the levels of IT compliance risk and control effectiveness to key stakeholders such as IT-business unit management, senior management, board of directors, legal management, regulators, internal/external auditors, etc.
• Lead the enterprise's response to privacy-related emergencies and other potentially damaging events.
• Create an IT compliance training and awareness program that periodically educates the requisite end-user community on the relevant IT compliance requirements and certifies their adherence to the relevant IT compliance controls.
• Monitoring of ITGCs compliance for SOX requirements.
• Reporting of ITGCs compliance for SOX.
• Supporting internal and external SOX audits.

Commercial Compliance Activities

• Ensure IT compliance and data protection requirements are effectively represented in contracts for IT products and services.
• Ability to review and assess adequacy of suppliers based on industry standard certification or report from IT suppliers in line with the company QMS (e.g., ISO 27001, Service Organization Control Reports, PCI DSS, GDPR, GxP, EMA Annex 11, MHRA GCP, HIPPA, SOX, etc.).

Organizational Compliance Activities

• Identify any gaps between the desired level of compliance and the current level of maturity.
• Implement the required IT compliance policies and controls to meet the desired level of compliance maturity reflected in each standard or framework.
• Participate in and contribute to wider organizational initiatives focussed on improvement of compliance standards and practices as well as to promote awareness and education.

Requirements

• Prior experience working in the life science / pharmaceutical industry (circa 5+ years)
• Experience with Health authority audits against IT controls in the life sciences / pharmaceutical industry.
• Experience with: Annex 11; FDA 21 CFR Part 11; GxP / GAMP 5
• Experience in development of processes and procedures (SOPs).

Following your application Simon Trebilcock, a specialist Scientific Recruiter with over 7 years’ experience recruiting in the scientific field will discuss the opportunity with you in detail. Eager to both give insight into the future of the opportunity and company but also learn more about your vision for your career growth. If desired Simon would look to remain in contact to alert you to opportunities which align with your interest and career plans.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0) 203 868 1001 .

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

A note from the author – Simon Trebilcock

Don’t meet every single requirement? Studies have shown that women and people from minority groups are less likely to apply to job adverts unless they meet every single qualification. At Planet Pharma we are dedicated to building diverse, inclusive and authentic workplaces, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the advert, we encourage you to apply anyway. You may be just the right candidate for this or other roles.