Manager/Sr. Manager, Clinical QA

Role: Clinical QA Manager/Sr Manager providing quality and compliance oversight for clinical trials within a biopharma setting, focused on ensuring GCP adherence. Responsibilities include evaluating and qualifying CROs, conducting audits for GCP compliance, managing CAPA processes, and collaborating with clinical teams to resolve non-compliance issues. The role involves developing and revising SOPs, guiding training efforts, and supporting regulatory inspections. Requirements: minimum 8 years in GCP/clinical QA, at least 3 years in GCP auditing, deep knowledge of GCP, GLP, ICH E6(R3), and experience with audit processes. Preferred: strong organizational, communication, and interpersonal skills, along with decision-making and problem-solving capabilities. High-value: extensive GCP expertise, experience with clinical audits, and regulatory compliance, supporting clinical development activities. Work setup: travel 25-35%; based on candidate location, potentially hybrid or onsite.