Description
We are seeking a Quality Assurance Lead to join our team and make an impact on quality across our clinical research operations. As a Quality Assurance Lead, you will serve as a quality partner to operational teams, providing guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities.
Key Responsibilities:
- Provide guidance on quality issue management, quality risk identification, escalation requirements, and continuous improvement opportunities to operational teams.
- Partner with internal stakeholders to facilitate the progression and resolution of quality issues within the Quality Management System (QMS).
- Monitor and drive timely progression of quality issues while identifying and escalating risks that may impact compliance, quality, or client commitments.
- Collaborate with functional teams to develop, implement, and monitor Corrective and Preventive Actions (CAPAs) to support sustainable issue resolution.
- Maintain a strong working knowledge of quality systems, processes, and regulatory requirements to support effective quality issue management.
- Partner with Quality Lead Managers and senior quality leadership to support quality issue progression, escalation activities, and client communications as required.
- Analyze quality metrics and trends to identify systemic quality concerns, emerging risks, and opportunities for continuous improvement, supporting risk-based decision making.
- Support preparation of quality summaries, trend analyses, and quality-related communications for internal stakeholders and clients, where applicable.
- Contribute to process improvement initiatives that strengthen compliance, quality oversight, and operational effectiveness.
Requirements:
- 5 years of experience in a regulatory environment, including experience in GxP roles.
- Strong understanding of QMS and the CAPA process.
- Knowledge of GCP and GxP requirements.
- Ability to convey key details of quality issues internally.
- Ability to communicate quality issue summaries to clients, where applicable.
- A bachelor’s degree in Life Sciences preferred, or equivalent Life Science experience.
Work Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
Physical Requirements:
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
Salary and Benefits:
- Pay Range: USD $70,000-$125,000
- Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.