QA Manager

Manager/Director - Clinical QA

We are seeking a highly motivated and experienced Manager/Director - Clinical QA to join our client's Clinical QA team. The Manager/Director - Clinical QA will be responsible for developing, directing and implementing Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements. The Manager/Director - Clinical QA will also be responsible for ensuring that Clinical studies are conducted in compliance with study protocols, GCP, GLP and federal guidelines.

Key Responsibilities:

• Lead the development, direction, and implementation of Quality Systems/Programs to guarantee adherence to industry and regulatory requirements and company standards.
• Ensure Clinical studies' compliance with study protocols, GCP, GLP, and federal guidelines.
• Oversee the SOP Process, including identifying, developing, approving, implementing, reviewing, revising, controlling, and archiving all SOPs.
• Apply quality by design principles and execute a risk-based approach in auditing processes.
• Conduct audits of clinical trial sites (Investigators), vendors, and contract research organizations throughout various phases of a clinical research study (as appropriate).

Key Requirements:

• Bachelor's or Master's degree in Life Sciences or related field.
• Minimum of 5 years of experience in Clinical QA, with a focus on auditing clinical trial sites (Investigators) during various phases of a clinical research study (as applicable), vendors and contract research organizations.
• Thorough knowledge of GCP, GLP and federal regulations.
• Experience with Quality Systems/Programs and SOP management.
• Excellent communication, interpersonal and leadership skills.
• Ability to work independently, prioritize tasks and meet deadlines.
• Strong problem-solving skills and attention to detail.