Associate Director, Quality Control Compliance

About Apogee TherapeuticsFounded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.If this sounds like you, keep reading!Role SummaryWe 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.Key Responsibilities• Build and maintain QC infrastructure and compliance systems in partnership with subject matter experts to ensure phase-appropriate compliance with evolving industry regulations (e.g., FDA, EMA, ICH).• Represent QC/Tech Ops in Change Control process development/improvement and facilitate all QC and TechOps change control• Provide compliance review and approval of all QC documentation, including SOPs, CofAs, protocols, reports, investigations• Lead OOS/OOT and complex testing investigations at CMDOs in partnership with subject matter experts• Lead initiatives to enhance quality control processes and systems, driving efficiency and effectiveness• Communicate compliance-related issues and updates to relevant stakeholders in a clear and concise manner.Ideal Candidate• 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%The anticipated salary range for candidates for this role will be $155,000 - 180,000/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.What We Offer• 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 solveE-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.To review our privacy policy, click here