- Responsible for all quality-related matters related to manufacturing, testing, and release at a CMO (Contract Manufacturing Organization); act as the technical subject matter quality expert for all matters governed by GMP related regulations and guidelines as it relates to manufacturing, testing and controls.
- Lead and support activities related to external quality such as, but not limited to, batch reviews and release, analytical method validations, tech transfers, deviations, quality agreements, and supplier qualifications including auditing and monitoring.
- Collaborates with internal CMC functions and aligns goals and objectives from clinical to commercial phase programs and small molecule products, ensuring cGMP compliance and realization of value-added policies and best practices.
- Ensures that the quality policies and objectives are understood, implemented, and maintained for all applicable GMP roles. Identifies gaps and provides solutions for new processes and documents to ensure readiness for inspections and audits.
- Author and review or approve quality documents including quality agreements, certificates of release, and audit reports.
- Attend CMO and internal CMC team meetings and provide quality feedback supporting Alumis products including collaborations on complex investigations.
- Attend and support quality system and product review meetings including providing data for quality metrics (internal and vendor metrics). Provide quality reviews of key CMC and health authority documents. Review and verify data to assure compliance with data integrity.
- Represent Quality on project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings.
- Promote a quality mindset and quality excellence approach throughout the organization.
- PhD in a scientific discipline with 8+ years, or a master's degree with 10+ years, bachelor's degree with 12+ years, experience in GMP quality roles years or equivalent combination of education and work experience.
- Five or more years of people's management experience.
- Strong understanding of small molecule manufacturing with direct experience in solid oral dosage.
- Experience with a small virtual company and Quality Control experience is a plus.
- Strong knowledge of global GxP expectations, QP (Qualified Person) requirements including work with health authorities.
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment.
- Develops key quality system metrics and process indicators to proactively identify and address quality systems or product issues.
- Strong interpersonal skills, with experience in leading high-performance team and cross functional projects including a successful track record working with suppliers and CMOs.
- Extensive GxP knowledge with early phase drug development through commercialization.
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CMOs.
- Goal oriented with the ability to troubleshoot and resolve problems.
- Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes and appropriately structured quality operations.
- Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others.
- Team building and managing skills including recruiting, coaching, counseling, and disciplining.
- Some travel required.
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Director, GMP Quality Assurance - South San Francisco, United States - Alumis Inc.
Description
Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients.
We are seeking a Director of GMP Quality Assurance reporting to the Senior Director of GMP Quality Operations. The Director will be responsible for providing quality operational support for the CMC teams and supporting the quality organization in building the Alumis quality systems and processes. This role will also serve as the backup to the Senior Director.
This position requires extensive expertise in current Good Manufacturing Practices (GMP) and relevant regulations. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide support to ensure that the quality function maintains the standards expected by global regulatory authorities.
Essential Duties & Responsibilities
Education & Experience
Knowledge | Skills | Abilities
Alumis Values
This position is located in South San Francisco, CA. At this time we are not considering remote applicants.
The salary range for this position is $220,000 USD to $233,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company's compensation practices.
Alumis Inc. is an equal opportunity employer.
