Associate Director, Clinical Quality Assurance

April 24

Apogee Therapeutics

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Apogee Therapeutics, LLC is a biotechnology company advancing novel, potentially best-in-class therapies to address the needs of the millions of people living with immunological and inflammatory disorders.

Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• 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

Requirements

• Bachelor's degree in a relevant biological sciences or equivalent is required • 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

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