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 Senior Manager of GMP Quality Assurance to work closely with the CMC Team to ensure quality oversight of external suppliers and contract manufacturing organizations (CMOs) activities. The Sr. Manager 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 position requires 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
- Review and approve API and drug product manufacturing, packaging, and labeling-related documents for pre and postproduction. Disposition of batches supporting global studies will also be required.
- 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.
- Attend CMO team meetings and provide quality feedback supporting Alumis products including collaborations on complex investigations.
- Provide guidance and impact assessments for change controls and CAPAs.
- Support the implementation of GMP activities as required by internal procedures and application of regulatory requirements.
- Attend and support quality system and product review meetings. Provide quality reviews of key CMC and IND enabling 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.
Education & Experience
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering or related scientific field.
- Minimum 8+ years of GMP Quality Assurance experience.
- Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.
- Knowledge in clinical development to commercial is desired.
Knowledge | Skills | Abilties
- Ability to make timely and sound quality decisions when faced with complex supply, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
- Hands-on experience in quality support of GMP manufacturing and development. Experience with QC and analytical testing is a bonus.
- A successful track record working with suppliers and CMOs.
- Knowledge of Quality Management Systems; experience in implementing and managing quality systems (paper based and Veeva EDMS) in the pharmaceutical industry.
- Extensive knowledge of FDA, EMA, and ROW GMP regulations and ICH guidance’s.
- Excellent verbal and written communication skills.
- Collaborative, analytical, and interpretative skills.
- Ability to work with minimal supervision and to set priorities to meet timelines.
- Previous experience in successfully working with cross-functional teams.
- Some travel required.
Alumis Values
- Elevate
- Challenge
- Nurture
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 $170,000 USD to $190,000 USD annually. This salary range is an estimate, and the actual salary my very based on the Company’s compensation practices.
Alumis Inc. is an equal opportunity employer.