Associate Director - Clinical Quality Assurance

Description: • We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (CQA) • This key role will report to the Head of Clinical Quality Assurance • Responsible for assisting with the establishment of a robust QA system for our clinical operations • Ensure compliance with regulatory standards, and promote a culture of quality throughout the organization Requirements: • Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus • 8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function • Minimum of 6 years of direct audit experience in GCP • 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 25% per year including for company meetings Benefits: • A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • Flexible PTO • Two, one-week company-wide shutdowns each year • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve Apply Job!