Associate Director, Quality Assurance

SriSai Biopharmaceutical Solutions (SBS) is entering a pivotal stage of organizational and regulatory growth. We are seeking an Associate Director of Quality Assurance who will lead the charge in transforming our Quality Management System (QMS), driving audit readiness, and building a world-class quality culture across all departments. This position is not for a maintainer—it’s for a builder and reformer: someone ready to lead a full QMS turnaround, close legacy gaps, modernize systems, and mentor a developing QA team. The right candidate will have the gravitas to engage directly with executive leadership, the FDA, and key clients, and the hands‑on skill to implement controls that ensure SBS operates with discipline, integrity, and inspection‑ready confidence every day. Responsibilities

Quality Systems & Compliance Leadership Redesign and strengthen SBS’s QMS to align with FDA cGMP and global regulatory expectations. Lead the development, revision, and enforcement of SOPs—closing all procedural gaps identified in recent audits. Oversee CAPA, deviation, and change‑control systems to ensure timely closure, proper root‑cause analysis, and prevention of recurrence. Direct internal and external audits, vendor qualifications, and regulatory inspections; ensure full preparedness and rapid, compliant responses. Regulatory & Risk Oversight

Act as the primary QA authority during audits and inspections. Establish proactive risk‑assessment and management practices across all functions. Ensure all materials—including critical utilities such as liquid nitrogen—are properly tested, qualified, and documented prior to use. Implement robust supplier and consultant qualification programs consistent with 21 CFR 211.34. Data Integrity & Validation

Partner with IT to validate computerized systems and GMP‑critical spreadsheets. Embed data integrity principles (ALCOA ) throughout operations and documentation. Training & Quality Culture

Build a comprehensive QA training and onboarding program covering GMP fundamentals, documentation standards, and inspection readiness. Coach QA managers and staff to elevate technical judgment, accountability, and cross‑functional collaboration. Drive a “Quality Is Everyone’s Job” mindset across Operations, Facilities, and all support departments. Strategic Planning & Reporting

Evaluate QA structure, resources, and performance metrics to support SBS’s growth strategy. Present timely risk reports, audit summaries, and QMS performance updates to senior leadership. Champion continuous improvement initiatives that enhance transparency, consistency, and customer trust. What Success Looks Like

All SOPs and quality systems are current, clear, and cGMP‑compliant. Audit and inspection readiness are sustained year‑round. QA issues are identified early, resolved quickly, and prevented systematically. Staff are well‑trained, documentation is complete, and regulatory confidence is strong. SBS earns recognition from clients and auditors as a company that delivers with integrity and excellence. Qualifications Required

Bachelor’s degree in Life Sciences, Chemistry, Biology, or related discipline. Minimum 8 years of progressive QA experience in pharmaceuticals, biologics, or related regulated environments, with at least 3 years in a leadership role. Deep working knowledge of cGMP, GLP, and GCP principles. Proven experience remediating audit findings and implementing corrective‑action programs. Demonstrated ability to lead QA transformations—building systems, teams, and culture from the ground up. Strong interpersonal and communication skills; able to influence across executive and technical levels. Preferred

Advanced degree (MS, PhD, or equivalent). Experience with both clinical‑phase and commercial manufacturing quality systems. Familiarity with PDA’s Quality Culture Maturity Model and ISPE’s Pharmaceutical Quality Systems framework. Prior success in integrating electronic QMS tools or managing site‑wide remediation projects. Why Join SBS

SriSai Biopharmaceutical Solutions is a trusted biopharma partner known for precision, reliability, and responsiveness. As we enter our next stage of growth, we are investing in a quality function that matches our scientific ambition. You’ll have the authority, resources, and executive sponsorship (from the EVP & CSO and EVP & COO) to rebuild and lead a best‑in‑class Quality organization. RICE Values

Respect | Integrity | Customer‑Centered | Excellence How to Apply

Qualified applicants should submit a résumé and cover letter detailing relevant QA leadership experience, examples of successful audit remediation or system transformation, and familiarity with FDA or EMA inspection environments.

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