Senior Manager, GMP QA

South San Francisco

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. 

Alumis is hiring a Senior Manager of GMP QA reporting to the Director of GMP QA. The role will work closely with the CMC Team to ensure quality oversight of external contract service providers (CSP) involved in GMP operations.

The Senior Manager will be responsible to provide the quality operational support for the CMC teams and support 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 all API and drug product manufacturing, packaging, and labeling related documents for pre and postproduction in agreed upon timelines and targets. 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.
  • Act as the Quality Site Lead (QSL) at the specified CSP by leading and supporting activities related to external quality such as, but not limited to, batch reviews and release, temperature excursions, clinical label review and/or approval, change controls, master batch records, analytical method validations, tech transfers, specification updates, stability report review, retest extension, deviations, quality agreements, and supplier qualifications including auditing and monitoring.
  • Attend CMO team meetings and provide quality feedback and mitigation pathways 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.
  • Provide support in investigations and assessment as the QA SME for internal deviations and change controls (if applicable).
  • 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 CSP operational meetings, and QA to QA meetings.
  • Promote an engrained quality mindset and quality excellence approach throughout the organization.
  • Work effectively and collaboratively throughout the organization to foster a culture focused on quality, teamwork and partnerships.

EDUCATION & EXPERIENCE

  • Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering or related scientific field.
  • Minimum 10-12 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/ ABILITIES

  • 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.
  • 20% travel required.

The salary range for this position is $ 176,000 USD to $186,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices. 

 

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday.*  At this time we are not considering remote applicants.

Alumis Inc. is an equal opportunity employer.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.  

Other benefits include:

  • Health insurance premiums paid at 90% for employee, 80% for dependents
  • Free access to Genentech Bus & Ferry Share program
  • $100 monthly cell phone stipend
  • Unlimited PTO for Exempt employees
  • Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

*Alumis Lab personnel are generally onsite 4-5 days/week 

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