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

🕒 2 days ago

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ProPharma

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 2001

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $8.6M Venture Round on 2020-10

Pharmaceuticals • Biotechnology • Healthcare Insurance

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.