We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (QA) to join our team. This key role will be responsible for assisting with establishing and supporting a robust QA system for our clinical operations, ensuring compliance with regulatory standards, and promoting a culture of quality throughout the organization. 

Key Responsibilities

• Assist QA Leadership with development and execution of planned QA audit schedules supporting clinical study programs.
• Independently performs assigned GCP audits e.g. clinical investigator sites, vendor qualifications, trial master files, internal processes and clinical study documents.
• Partner effectively with clinical functions and provide quality guidance to drive quality in clinical data and documentation generated.
• Facilitate investigation of reported quality events, evaluate and approve appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence.
• Contribute to the development and maintenance of clinical QA procedures and other governance standards as needed.
• Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization.
• Assist in the development and/or delivery of GCP training topics and quality standards as directed.
• Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals.
• Collaborate with Process Excellence team in support of inspection readiness activities.
• Perform key activities during regulatory authority inspection and/or external audits as directed by QA Leadership.

 The Ideal Candidate will Possess

• Bachelor's degree in a relevant biological sciences or equivalent is required.
• Advanced degree a plus.
• Minimum of 7 years of direct audit experience in GCP quality assurance within the biotech or pharmaceutical industry, with increasing responsibilities in the Clinical QA function.
• In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements.
• Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators.
• Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change.
• Excellent problem-solving and critical thinking abilities.
• Flexible and creative to meet the needs and challenges of a growing, dynamic company.
• Focus on fostering a culture of collaboration and teamwork.
• Ability to manage multiple projects with aggressive timelines and changing priorities.
• Ability and willingness to travel up to 20% per year including all company meetings.

The anticipated salary range for candidates for this role will be $170,000-$190,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.