Job Description:
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.
