Original listing text, shown exactly as published by the company.
Key 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
Ideal Candidate
- A bachelor’s degree in relevant scientific discipline or equivalent is required, advanced degree a plus
- A minimum of 8 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, additional travel may be required to attend visits to vendors, CDMOs, etc. domestic and international travel is required
The anticipated salary range for candidates for this role will be $165,000-$195,000. 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.
