Associate Director - Auditor - Computer System Validation , AI Assurance, Data Integrity

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is currently expanding its Compliance and Quality Assurance team with its newest Permanent auditor which can be based in any of our Eastern European hubs (remote based in Serbia, Croatia, Bulgaria or Bosnia). This is a newly created position within our organisation at its key focus will be to audit clients in Computer System Validation, AI Assurance & Data Integrity across the EMEA.

Responsibilities

• Conduct Audits of Pharmaceutical, medical device, clinical, and software development organizations for compliance with health authority regulations applicable to computer systems, artificial intelligence, data integrity

• Conduct gap assessments and provide remediation guidance for compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity

• Authoring policies, procedures, and work instructions compliance with health authority regulations applicable to computer system, artificial intelligence, and data integrity

• Provide clients with advice and guidance on computer system validation, AI compliance, and data integrity compliance approaches. Manage teams of internal resources in executing these strategies.

• Assist in developing and maintaining internal procedures and tools for delivery of CSV, AI assurance, and data integrity services.

• Develop and deliver original CSV content on current topics impacting the area of Computer System Validation, AI compliance, and electronic data integrity. Examples include blogs, training materials, webinars.

• Teach computer system validation, software/AI quality compliance, and data integrity classes, as needed.

• Participate in development of business strategies for growth of ProPharma’s CSV, AI Assurance, and Data Integrity practice.

• Assist in development of the Marketing and Sales materials.

• Assist in Business Development activities.

• Assist Operations in staffing client projects.

• Lead interviews of ProPharma Group candidates.

• Some travel required.

• Other duties as assigned.

Required skills and experience

• Educated to a BSc or higher within a life-sciences or related discipline to the role

• Certified auditor

• Minimum 10 years auditing experience. At least 30 audits in one or more of these areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, electronic data integrity.

• Minimum 15 years in Pharma/Med Device industry

• Fluent in English and ideally one other EU language

• Experience in the validation of all computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.

• Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem. 

• Basic understanding of AI use cases and emerging GxP compliance requirements

• Experience in authoring policies and procedures (SOPs).

• Experience conducting audits and gap assessments.

• Experience managing internal personnel, contract resources, and projects.

• Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.

• Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, such as those from ICH and PIC/S.

• Expert knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).

• Expert knowledge of Data Integrity guidance documents, such as those from the US FDA, EMA, MHRA, PIC/S, and WHO.

• Proficiency public speaking via in person and online forums.

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***