Director, GMP Quality Assurance

🕒 April 27

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Biotechnology • Pharmaceuticals

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.

📋 Description

• Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities • Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities • Independently performs assigned GMP audits • Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated • Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement • Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products • Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards • Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.) • Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events • Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures • Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization • Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness • Ensure employees are adequately trained in GMP requirements and quality procedures • Maintain comprehensive and accurate records and reports related to quality assurance activities • Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety • Assist in GMP inspection readiness activities to support regulatory authority inspections

🎯 Requirements

• A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus • A minimum of 10 years of experience in GMP quality assurance within the biotech or pharmaceutical industry, with direct experience in auditing and the manufacture of monoclonal antibodies or biologics • Experience with CDMO oversight, including partnering and aligning on quality issues • Experience with Quality Management System Regulations is a plus • In-depth knowledge of GMP regulations and guidelines, including FDA, EMA, and ICH requirements • Experience with analytical instrumentation, methods, validation, and investigations including stability program management • Extensive experience using electronic QMS to monitor, report, and track quality tasks, and key quality performance indicators • Strong communication (oral and written), and effective interpersonal skills with the ability to influence 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 fast timelines and changing priorities • Position requires up to 20% travel including mandatory in-person attendance at All Hands meetings typically held twice per year

🏖️ 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 • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • 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