QA & Compliance Associate

Acrosian is an AI-augmented biometrics CRO building its quality management system from the ground up. The QA & Compliance Associate is the day-to-day engine of that system — owning controlled documents, training records, audit logistics, and CAPA follow-through so that the QMS remains inspection-ready as the organization scales.
This is a build role, not a maintenance role. The incumbent will be writing and administering processes that do not yet exist, working within a global quality function that serves delivery teams in India, Europe, and the United States.

Document and Training Control

• Administer the electronic Quality Management System (ZenQMS): document lifecycle from draft through periodic review, workflow configuration, and user administration.
• Maintain the controlled document numbering scheme, revision history, and effective and retirement dates.
• Own the training matrix — assign, track, and escalate overdue curricula; maintain training records for employees and contractors across India, Europe, and the United States.

Audit and Vendor Oversight

• Support sponsor audits and regulatory inspections, including preparation, document retrieval, response tracking, and remote audit logistics.
• Support vendor qualification assessments — questionnaires, evidence review, findings trackers, CAPA verification, and requalification scheduling.
• Assist with internal audits against the approved audit schedule and track findings to closure.

Quality Events

• Log, triage, track deviations, non-conformances, and CAPAs; drive owners to on-time closure and verify effectiveness.
• Escalate trends and recurring issues to the Chief Audit and Compliance Officer.

Compliance Support

• Support compliance activities under ICH E6(R3), Indian GCP and the New Drugs and Clinical Trials Rules, 2019, and 21 CFR Part 11.
• Support data protection compliance under the Digital Personal Data Protection Act, 2023, and the GDPR for EU-sourced clinical data.
• Assist with computer system validation documentation and periodic system reviews.
• Support responses to sponsor quality and data security questionnaires.
• Support compliance monitoring for internal AI usage policies as those systems are deployed.

Required

• B.Pharm / M.Pharm, M.Sc. in life sciences, or equivalent.
• ISO 9001 and/or ISO 27001 Certifications OR, ISO/IEC 42001 (AI management system) Certifications preferred
• 2–5 years in QA or compliance within a CRO, pharmaceutical, biotechnology, or medical device organization.
• Working knowledge of ICH GCP and 21 CFR Part 11.
• Hands-on experience with an electronic QMS.
• Strong written English — SOPs, audit reports, and CAPA records are writing tasks.
• Meticulous follow-through, including the confidence to pursue senior stakeholders on overdue commitments.
• Demonstrated ability to work effectively in a fully remote, distributed team.
• Willingness to overlap several hours daily with US Eastern and European working hours.

Preferred

• Experience in clinical data management, biostatistics, or statistical programming environments.
• Exposure to computer system validation, data integrity (ALCOA+), or information security frameworks.
• Familiarity with ZenQMS.
• Certification, or demonstrable progress toward certification, as CQA, CISA, or RAC.

• A strategic thinker with a hands-on leadership approach.
• A strong people leader with a track record of building and developing high-performing teams.
• Someone who can prioritize competing business needs, manage risk proactively, and drive execution in a fast-paced environment.
• A genuine customer focus and the ability to build trusted, long-term sponsor relationships.
• Passion for operational excellence, innovation, and continuous improvement.