SriSai Biopharmaceutical Solutions. LLC · 3 months ago
Associate Director, Quality Assurance
FREDERICK, Maryland, United States
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$110K/yr - $130K/yr
8+ years expSriSai 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) and driving audit readiness across all departments.
BiotechnologyHealth CareMedicalPharmaceuticalSupply Chain Management
Responsibilities
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
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
Partner with IT to validate computerized systems and GMP-critical spreadsheets
Embed data integrity principles (ALCOA+) throughout operations and documentation
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
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
Qualification
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
Company
SriSai Biopharmaceutical Solutions. LLC
SriSai Biopharmaceutical Solutions (SBS) has been providing comprehensive support services to the life sciences industry for over 15 years in the areas of supply chain management.
11-50 employees
H1B Sponsorship
SriSai Biopharmaceutical Solutions. LLC has a track record of offering H1B sponsorships. Please note that this does not
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2025 (1)
2022 (1)
Funding
Current Stage
Early StageCompany data provided by crunchbase