Quality Assurance Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as a quality partner for operational teams by offering guidance on managing quality issues, identifying quality risks, escalating requirements, and spotting continuous improvement opportunities.

• Collaborate with internal stakeholders to enhance the progression and resolution of quality issues within the Quality Management System (QMS).

• Oversee and ensure the timely advancement of quality issues while recognizing and escalating risks that could affect compliance, quality, or client obligations.

• Work alongside functional teams to create, implement, and monitor Corrective and Preventive Actions (CAPAs).

• Maintain a thorough understanding of quality systems, processes, and regulatory standards to assist in managing quality issues.

• Collaborate with Quality Lead Managers and senior quality leadership on the progression of quality issues, escalation procedures, and client communications.

• Analyze quality metrics and trends to pinpoint systemic quality challenges, emerging risks, and avenues for continuous improvement.

• Assist in preparing quality summaries, trend analyses, and quality-related communications for both internal stakeholders and clients.

• Participate in process improvement initiatives to enhance compliance, quality oversight, and operational efficiency.

• Perform additional duties as assigned.

• Occasionally drive to site locations and travel both domestically and internationally.

⛳️ Requirements

• Minimum of 5 years of experience in a regulatory environment, including experience in GxP roles.

• Solid understanding of QMS and the CAPA process.

• Familiarity with GCP and GxP requirements.

• Capability to communicate key aspects of quality issues internally.

• Ability to summarize quality issues for clients, as necessary.

• A bachelor's degree in Life Sciences is preferred, or equivalent experience in Life Sciences.

• Relevant and equivalent experience may be considered in place of educational qualifications.

• Candidates must be authorized to work in the United States without the need for sponsorship.

• Proficiency in accessing and utilizing various software programs, both developed in-house and off-the-shelf.

• Regular and consistent attendance is required.

• Flexibility in working hours may be necessary.

• Frequently remain stationary for 6-8 hours per day.

• Repetitive hand movements with both hands, including the ability to perform quick, simple, repeated motions of the fingers, hands, and wrists.

• Occasional crouching and stooping, along with frequent bending and twisting of the upper body and neck.

• Light to moderate lifting and carrying of objects, including luggage and a laptop computer, with a maximum weight of 15-20 lbs.

🏝️ Benefits

• Medical

• Dental

• Vision

• Life insurance

• Short-term disability (STD)

• Long-term disability (LTD)

• 401(K)

• Paid time off (PTO) or Flexible time off (FTO)

• Company bonus where applicable