Senior Specialist, Quality Assurance, Clinical Quality

Job Description

Our Research Laboratories Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle. The QA Clinical Quality (CQ) team ensures the safety, rights, and well‑being of participants and compliance with regulatory requirements through sound processes and strategies.

• Lead and prioritize own tasks to produce high‑quality deliverables within a team.
• Contribute to overall team goals by excelling in the individual role and proactively improving skills.
• Collaborate with internal and external colleagues, including Clinical Operations, to drive corrective and preventive actions and close QA observations.
• Prepare, conduct, and report on QA audits, including GCP audits of investigator sites, suppliers, and third‑party collaborations; perform risk‑based audits based on critical quality factors.
• Support the QA Lead in selecting audit substrates, scheduling, and ensuring timely escalation of quality issues, including potential misconduct or significant deviations.
• Interface with QA functional lines to provide day‑to‑day support and ensure appropriate oversight of assigned studies.
• Assess compliance of clinical sites, vendors, and study activities against ICH guidelines, government regulations, and company policies.
• Develop and deliver awareness sessions on GCP, pharmacovigilance, and related topics with minimal supervision.
• Promote standardization of auditing approaches and suggest new audit techniques where appropriate.

• BS/BA degree or equivalent; 3–5years of relevant experience.
• Comprehensive working knowledge of Quality Assurance, regulations, and auditing.
• Proficiency in primary duties and essential skills required for the role (audit, risk assessment, compliance review).

• Analytical thinking
• Audits & compliance
• Clinical research & trials
• Attention to detail
• Ethical compliance
• GCP auditing
• Investigative skills
• Metrics analysis
• Process improvement
• Stakeholder management
• Ownership & accountability
• Time management

Salary range: $ – $ (based on experience, qualifications, and location).

Eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.

We are an Equal Employment Opportunity Employer. All qualified applicants will receive equal consideration for employment regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.