Associate Director - Clinical Quality Assurance

February 25

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Apogee Therapeutics

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Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking a dynamic and results-driven Associate Director of Clinical Quality Assurance (CQA) to join our team. • This key role will report to the Head of Clinical Quality Assurance and is responsible for assisting with the establishment of a robust QA system for our clinical operations. • In this role, you will 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