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Director of Quality Management and Compliance

Alphalife Sciences| Ai Powered Clinical Research Platform - Jersey City, NJ, United States - In-office - posted 2026-10-01

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AlphaLife Sciences, an AI-enabled clinical research platform founded by former Google and Verily leaders, is seeking a Director of Quality Management and Compliance to build and own the company's security and compliance program from the ground up. You will serve as AlphaLife's senior security and compliance leader, protecting the company, clients, and intellectual property from internal and external threats. Your responsibilities include: - Assess and respond to security risks across platform, infrastructure, and corporate systems, determining credibility and prioritizing response. - Build and formalize security policies, standards, and procedures aligned with regulatory requirements. - Partner with US and international law firms to draft, implement, and enforce policies meeting legal and regulatory standards. - Safeguard sensitive scientific, clinical, and commercial data, with focus on protecting intellectual property. - Monitor international data and security regulations; advise leadership on cross-border data sharing and geopolitical risk in key markets. - Represent AlphaLife at industry conferences and serve as primary security contact for pharmaceutical clients, law firms, and partners during security reviews and due diligence. - Own compliance certifications and framework alignment, including ISO 27001 and SOC 2; maintain platform and process alignment with GxP and HIPAA requirements. The ideal candidate pairs strong technical foundation with deep compliance policy expertise. You understand life sciences data protection and regulatory frameworks (ISO 27001, SOC 2, GxP, HIPAA) inside and out, can navigate international regulations and cross-border data risk, and bring executive presence to represent AlphaLife on security policy and legal matters. Background: You may come from IT and security leadership at big pharma, or regulatory policy leadership at a life science SaaS company. REQUIREMENTS: - Bachelor's or Master's degree in Computer Science, Cybersecurity, Information Systems, or related field - 10+ years in cybersecurity, information security, or security compliance, including building or leading a security program - Strong technical foundation in cloud security, application security, threat detection and response - Experience protecting sensitive data in life sciences, pharma, biotech, or highly regulated industry - Deep understanding of intellectual property and experience safeguarding proprietary scientific or commercial information - Working knowledge of international data protection and security regulations (GDPR, PIPL, US federal/state frameworks) and cross-border data transfer requirements - Deep familiarity with life science industry's data protection and regulatory compliance policy, including HIPAA and GxP; frameworks such as ISO 27001 and SOC 2 (compliance policy fluency weighted heavily) - Experience working with outside legal counsel to draft and implement policy - Excellent communication skills and executive presence; comfort presenting to senior client stakeholders and conference audiences - Comfortable in fast-paced startup environment with ambiguity and evolving priorities NICE-TO-HAVE: - Certifications: CISSP, CISM, CISA, or CCSP - Experience leading SOC 2 or ISO 27001 efforts at startup or growth-stage company - Hands-on experience with 21 CFR Part 11 and computer system validation - Experience in or alongside China market - Background securing AI/ML or Generative AI platforms

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