Associate Director - Quality Control Compliance

September 19

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Apogee Therapeutics

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Immunology & Inflammation

51 - 200

💰 $149M Series B on 2022-12

Description

• We are seeking an Associate Director, Quality Control (QC) Compliance responsible for building QC processes and procedures that adhere to regulatory standards and company policies. • This individual will be an important member of the TechOps team, managing multiple parallel activities supporting all stages of product development.

Requirements

• Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 8+ years of QC-related experience with complex biologics, particularly monoclonal antibodies, spanning early and late-stage development (or equivalent combination of education and experience). • In-depth knowledge of regulatory requirements and industry standards related to QC. • Deep experience with establishing and driving QC compliance processes, such as change control, CAPA, OOS/OOT investigations, and lab exceptions. • Proficiency in quality management systems (QMS) and related software. • Proven experience with audit processes, compliance management, and quality improvement initiatives. • Hands-on GMP QC experience in QC testing. • Experience partnering with CDMOs/external laboratories to establish and generate GMP QC data. • Excellent communication and interpersonal skills with an ability to collaborate effectively across functional lines. • Ability to work independently and multi-task in a fast-moving organization. • Availability to participate in calls across multiple international time zones. • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. • Ability and willingness to travel up to 20%.

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.