What are the responsibilities and job description for the Clinical Quality Assurance Manager position at Pharmiweb?
Job Title : Clinical Quality Assurance Manager
Location : California (Hybrid)
Key Responsibilities
- Support the Clinical Quality Assurance function to develop and implement strategies, policies, and standards aligned with regulatory requirements.
- Build and maintain strong working relationships with internal teams and external stakeholders, including Contract Research Organizations (CROs), to ensure compliance across clinical programs.
- Provide expert guidance on complex quality-related topics related to Good Clinical Practice (GCP).
- Assist in cross-functional quality initiatives, including Good Laboratory Practice (GLP) support when needed.
- Contribute to deviation management, risk assessments, CAPA implementation, regulatory submissions, and clinical documentation review.
- Develop and execute audit plans for clinical vendors in coordination with Clinical Development teams.
- Define compliance criteria for selecting new clinical vendors in alignment with GCP standards.
- Conduct routine evaluations of existing vendors to ensure continued adherence to regulatory requirements.
- Lead and perform vendor and investigator site audits, documenting and communicating findings effectively.
- Review audit reports from external contractors and provide insights to senior management.
- Support the continuous improvement of vendor oversight programs and internal quality audit processes.
- Monitor clinical program compliance and escalate systemic risks to senior leadership with recommendations for resolution.
- Assist in the development and refinement of Clinical Operations Standard Operating Procedures (SOPs).
- Collaborate with internal quality teams to mitigate compliance risks and drive continuous improvement initiatives.
- Provide risk assessments to facilitate informed decision-making for key stakeholders.
- Participate in quality management reviews and communicate compliance status to leadership.
- Prepare for and lead GCP-focused regulatory inspections and external audits.
- Ensure timely and effective responses to audit observations to maintain strong regulatory standing.
- Provide training and guidance to internal teams and external sites to enhance inspection readiness.
Qualifications & Experience :
