OVERVIEW

The Quality Assurance (QA) Manager plays a critical role in overseeing and executing Clinical Quality Assurance activities that uphold and enhance the organization’s Quality Management System (QMS). Reporting to Quality Assurance Leadership, this position ensures compliance with ICH GCP, applicable global regulations, and internal quality standards, while fostering a culture of continuous improvement.
The QA Manager leads key quality functions, including audits, quality event management, vendor qualification, training, and risk-based quality planning. This role partners cross-functionally with clinical operations, vendors, sponsors, and leadership to maintain operational excellence and ensure that clinical research activities meet both regulatory and sponsor expectations

VENDOR QUALIFICATION & OVERSIGHT

· Lead or support vendor qualification and requalification, including risk-based assessments, audits, and ongoing compliance monitoring.

EDUCATION & EXPERIENCE

· BS/BA/MS in Life Sciences, Pharmacy, Nursing, or a related field, or equivalent combination of education and experience; advanced degree (e.g., MS, MPH) preferred.
· 5-10 years of GCP Quality Assurance experience, preferably in a CRO environment.

KNOWLEDGE & SKILLS

· Deep knowledge of ICH GCP, FDA and other global regulatory guidelines.
· Experience in authoring, reviewing, and managing QMS documents and quality records.
· Excellent written, verbal, and presentation skills, with the ability to communicate complex concepts clearly.
· Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
· Strong organizational, time management, and prioritization skills; able to manage multiple projects in a fast-paced, matrixed environment.
· Analytical and risk-based thinking, with the ability to interpret quality metrics and drive continuous improvement.
· Effective in influencing, negotiating, and implementing effective quality solutions.
· Meticulous attention to detail with auditing and investigative skills.
· Proficient in Microsoft Office, QMS systems, and electronic Trial Master File (eTMF) platforms.
· Ability to handle sensitive and confidential information with discretion and integrity.
Join us in our commitment to delivering exceptional products by ensuring the highest levels of quality assurance throughout our operations.
Job Type: Full-time
Pay: $85,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: Remot