OverviewThe Site Quality Manager is responsible for ensuring the quality and regulatory compliance of operations within a central laboratory supporting clinical trials. This role oversees the implementation and maintenance of the Quality Management System (QMS), ensures adherence to GCP and applicable regulatory standards, and facilitates the site audit program. The manager plays a key role in driving continuous improvement and maintaining high standards of data integrity and clinical quality performance.
Please note: this is a hybrid role that will be performed 3 days per week onsite at our Cleveland, OH office and 2 days per week remotely. For candidates not local to Cleveland, a relocation award may apply. Essential Duties and Responsibilities
- Champion site-wide Quality initiatives, ensuring alignment with global regulatory standards and corporate excellence (e.g., CLIA, CAP, GCP, ICH, FDA, EMA).
- Assess and report on compliance with clinical trial protocols, sponsor requirements, and regulatory guidelines.
- Prepare for and facilitate sponsor audits, regulatory inspections (e.g., CLIA, CAP, FDA, EMA), and internal audits.
- Coordinate timely and strategic resolution of audit findings and CAPAs, reinforcing a culture of accountability and continuous improvement.
- Manage and oversee Quality Events including investigation, root cause analysis, implementation of robust CAPA plans, and effectiveness checks.
- Collaborate with lab operations, data management, project teams, and others to ensure quality in sample handling, testing, and reporting.
- Review method validations, equipment qualifications, and laboratory investigations.
- Identify process inefficiencies and facilitate quality improvement initiatives across departments.
- Monitor and report quality KPIs (e.g., audit outcomes, deviation trends, CAPA effectiveness).
- Provide regular updates to leadership and contribute to strategic quality planning.
- Prepare training materials and conduct training for QMS topics.
- Collaborates with Human Resources regarding training program requirements affected by the QMS.
- Performs other tasks as defined by Quality Assurance Leadership
Education and Experience
- Bachelor's degree in life sciences, medical technology, or related field.
- Minimum 4 years of experience in a central lab or clinical trial lab environment, with at least 2 years in a quality management role.
Skills and Ability
- Strong understanding of the CFR's, CLIA, CAP checklists, GCP, and ICH guidelines as they pertain to clinical trial operations.
- Strong understanding of the clinical laboratory and clinical trials environments. Excellent communication, leadership, and analytical skills.
Supervisory Responsibilities: None
Physical Demands:
While performing the duties of this job, the occupant is regularly required to:
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged use of computer and headphones for conference calls.
- Communicate effectively via phone, video, and email.
- Use hands and fingers to operate a computer and other office equipment.
- Sit 75% of the week.
- Stand 25% of the week.
- Walk and/or reach with hands and arms 15% of the week.
- Read text of various sizes.
- Communicate with others and hear.
- Lift, pull and/or push up to 25 pounds.
Travel Requirements: Minimal
Join our team and discover how your work can
impact patients' lives around the world!
Some of the Perks our LabConnectors Love:- Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
- Health Benefits beginning on date of hire
- PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
- Short and Long-Term Disability, Life Insurance, and AD&D
- We celebrate our differences, which enriches our culture!
In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of
People First, Quality Focused, Customer Centered, Technology Driven, and
Accountability Always.
