Associate Director, GMP QA

Company: Initial Therapeutics, Inc.
Location: San Francisco
Posted on: January 14, 2025

Job 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 an exceptionally motivated Associate Director, GMP QA, reporting to the Director of GMP Quality Assurance. The role will work closely with the CMC Team to ensure quality oversight of external vendors and contract manufacturing organizations (CMOs). The Associate Director 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

• 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.
• 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.
• 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 for the global network supporting Alumis products including collaborations on complex investigations.
• Ensure data for internal and external metrics are collected, reviewed and analyzed.
• Provide guidance, review and impact assessments for change controls and CAPAs.
• Support the implementation of GMP and GLP 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 an engrained quality mindset and quality excellence approach throughout the organization.
• Leads and fosters the culture of collaboration as it is a strong part of the Alumis culture.EDUCATION & EXPERIENCE
• Bachelors or advanced degree in Biology, Chemistry, Chemical Engineering or related scientific field.
• Minimum 13 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 manufacturing and/or analytical testing and development.
• 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.The salary range for this position is $195,000 USD to $208,000 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.
  #J-18808-Ljbffr

Keywords: Initial Therapeutics, Inc., San Jose , Associate Director, GMP QA, Executive , San Francisco, California