Director, GMP Quality Assurance

Role Overview

• 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