Dir., Clinical Quality Assurance

Job Title: Dir., Clinical Quality Assurance

Job Number: 90361

Location: , US

Job Description

The Director of Clinical Quality Assurance will oversee quality assurance activities related to Good Clinical Practice (GCP) to ensure compliance with applicable regulations (e.g., FDA, ICH, country-specific), SOPs, and industry standards for clinical trials. This role will manage the QA audit program, support quality systems, and guide internal and clinical study teams. The Director will ensure the effectiveness of quality programs and documentation to maintain GCP compliance and inspection readiness, while supporting clinical supply and delivery requirements. The position is based in the Boston area, with occasional on-site meetings every other month.

Responsibilities

* Collaborate with internal teams to ensure compliance with standards and manage GCP quality support for all project teams * Identify compliance risks and implement mitigation measures * Oversee the GCP audit program, conducting audits of clinical sites, vendors, processes, and study documents to ensure data integrity and regulatory compliance * Review and approve clinical SOPs, develop new QA SOPs, and create audit plans and schedules * Ensure timely follow-up on quality issues, conduct oversight of clinical documents, and lead or perform audits * Prepare audit reports, evaluate corrective actions, and deliver GCP training * Work with cross-functional teams to ensure compliance readiness and provide leadership for inspection preparedness * Report on audit findings, support process improvements, and stay updated on regulations and company standards

Required Skills

* In-depth knowledge of GCP, FDA, and EMA regulations for biologics products * Strong expertise in scientific and clinical disciplines * Proficient in clinical development and study methodologies * Excellent communication skills, both written and verbal, for internal and regulatory interactions * Able to challenge decisions and propose solutions with a focus on risk management * Skilled negotiator for securing operational resources to support clinical efforts * Fluent in both written and spoken English * Proven ability to train and mentor others * Comprehensive understanding of GCP and ICH clinical standards * Experience leading inspections by corporate, external, or regulatory authorities * Strong interpersonal skills for fostering relationships at all levels of the organization * Detail-oriented with an aptitude for identifying and addressing document inconsistencies * Self-motivated and collaborative in a dynamic, fast-paced environment * Available to travel domestically and internationally as required

Application Deadline: 2025-02-03