Associate Director – Clinical Quality

Associate Director – Clinical Quality

Requirements

• Bachelor’s degree in a scientific discipline or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
• Minimum 8 years of related experience with a minimum 5 years of experience in clinical quality management in the pharmaceutical or biotech industry.
• Experience and knowledge in the establishment and management of quality systems, vendor and investigator site audits, and CRO oversight.
• Working knowledge and adherence to FDA, ISO and ICH regulatory guidance and regulations, clinical quality operations, and CTD/eCTD standards.
• Exceptional interpersonal skills with the ability to effectively develop supportive and collaborative relationships.
• Superior organizational, communication, and problem-solving skills.
• Highly proficient in MS Office 365 (with an emphasis on MS Word).

Responsibilities

• Oversee all aspects of Clinical Quality for internal and external processes, including CROs, vendors, and investigator sites.
• Review internal and external documentation to ensure quality, regulatory compliance and audit-readiness.
• Document internal regulatory processes and evaluate quality events, incidents, queries, and complaints.
• Utilize guidance regulatory documents, international standards, and industry standards and interpret and apply to clinical trials and activities.
• Conduct audits of clinical documentation, investigator sites, vendors, systems.
• Lead root cause analyses and implement corrective and preventive action plans.
• Collaborate with internal and external stakeholders to align quality strategies with organizational goals.
• Assume a lead role in representing clinical quality at internal meetings and in preparing and drafting clinical quality policies, procedures, regulatory submissions and GCP training.
• Communicate any critical compliance risks to senior management and recommend possible solutions.
• Assist in the development of documentation and implementation of systems and SOPs.
• Support all Quality team needs as identified by management.
• Keep abreast of and make recommendations to management on new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Perform other responsibilities as required by business needs.

Preferred Qualifications

• Experience with cell therapy products and prior participation in regulatory inspections desirable.