Apogee Therapeutics - Director, GMP Quality Assurance
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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 • The anticipated salary range for candidates for this role will be $210,000-$235,000. 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.
Responsibilities
• 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
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 • E-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.
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