Senior Quality Assurance Scientist

Position Summary

We are seeking a highly skilled and experienced Senior Quality Assurance (QA) Scientist to join our client’s team. In this senior-level role, you will be a key driver of product quality, regulatory compliance, and continuous improvement initiatives across the organization. You will apply deep technical expertise to design and execute quality systems and serve as a cross-functional quality partner to R&D, manufacturing, and regulatory affairs.

Key Responsibilities

Quality Systems & Compliance

• Design, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with applicable regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, or industry equivalent).
• Lead and manage internal and external audits, including pre-audit preparation, execution, and CAPA follow-up.
• Maintain current knowledge of applicable regulations (FDA, EU MDR, ICH, GxP) and ensure organizational compliance through proactive gap assessments.
• Develop, review, and approve SOPs, work instructions, and quality documentation to ensure clarity and regulatory adherence.
• Oversee change control processes, ensuring all changes are properly documented, evaluated for risk, and validated prior to implementation.

Testing, Validation & Analytical Methods

• Design and execute validation protocols (IQ/OQ/PQ) for equipment, processes, software, and analytical methods.
• Develop and validate test methods in compliance with relevant pharmacopeial or industry standards; perform method transfers.
• Lead root cause investigation and failure analysis using structured problem-solving methodologies (8D, Ishikawa, 5-Why, FMEA).
• Review and approve batch records, test results, and deviations; ensure disposition decisions are science-based and defensible.
• Oversee stability programs, environmental monitoring, and in-process controls to ensure product integrity.

Cross-Functional Leadership & Continuous Improvement

• Serve as the quality representative on cross-functional project teams, providing QA guidance from design through launch.
• Partner with R&D, Regulatory Affairs, Manufacturing, and Supply Chain to drive quality-by-design principles.
• Lead Corrective and Preventive Action (CAPA) system; track and report trends in quality metrics to senior leadership.
• Mentor and coach junior QA staff, fostering a culture of quality, accountability, and continuous improvement.
• Identify and implement process improvement initiatives using Lean, Six Sigma, or other quality improvement frameworks.

Qualifications

Required

• Bachelor’s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; Master’s or Ph.D. preferred.
• Minimum 7 years of progressive, hands-on quality assurance experience in a regulated industry (pharmaceutical, biotech, medical device, or equivalent).
• In-depth knowledge of quality regulations and standards: FDA 21 CFR Parts 210/211/820, ISO 13485, ICH Q7/Q8/Q9/Q10, EU GMP Annex, or equivalent.
• Proven experience designing and executing validation protocols (process, method, equipment, CSV/computer systems).
• Demonstrated experience leading or supporting regulatory inspections (FDA, EMA, ISO/Notified Body) with successful outcomes.
• Strong root cause analysis skills with hands-on use of tools such as FMEA, Fishbone, 5-Why, and 8D.
• Experience authoring, reviewing, and approving complex quality documentation including SOPs, protocols, and technical reports.
• Proficiency with quality management software (e.g., MasterControl, Veeva, TrackWise, or similar platforms).

Preferred

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent professional certification.
• Six Sigma Green Belt or Black Belt certification.
• Experience with electronic batch record systems and data integrity programs (21 CFR Part 11 / Annex 11).
• Prior experience with combination products or Class II/III medical devices.
• Familiarity with supplier quality management and qualification programs.