Vice President, Quality Operations

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a VP of Quality to lead GMPQA operations and GLP functions. This pivotal role involves overseeing quality assurance in small molecule manufacturing, driving a culture of ethics and compliance, and collaborating with cross-functional teams to enhance quality standards. The successful candidate will have extensive experience in quality assurance, regulatory requirements, and team leadership, ensuring that the organization meets the highest quality expectations. Join a dedicated team on a mission to transform patients' lives and make a significant impact in the field of precision medicine.

Benefits

Health insurance premiums paid at 90% for employee

Free access to Genentech Bus & Ferry Share program

$100 monthly cell phone stipend

Unlimited PTO for Exempt employees

Free onsite gym

Kitchen stocked with snacks and drinks

Generous stock option grants

Annual bonus program

Qualifications

• Minimum 15 years of GMP Quality Assurance experience required.
• Strong understanding of small molecule manufacturing and solid oral dosage forms.

Responsibilities

• Lead GMP/GLP Quality functions and manage a high-performing team.
• Oversee quality activities and ensure compliance with regulatory standards.

Skills

GMP Quality Assurance

Leadership

Small Molecule Manufacturing

Analytical Testing

Regulatory Compliance

Collaboration

Communication Skills

Education

Bachelor’s or advanced degree in Biology, Chemistry, or Chemical Engineering

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.

Alumis is hiring a VP, Quality to lead the GMPQA Operations and GLP functions within Alumis. This role will work closely with the CMC and Preclinical leadership and support the clinical and research teams to ensure quality oversight of manufacturing operations and GLP testing facilities. We are seeking an individual with a robust scientific background in small molecule manufacturing who will proactively collaborate with the CMC and Preclinical team to uphold and enhance high-quality standards throughout our processes.

The successful candidate will drive, promote, and embed a culture of ethics, integrity, and proactive quality management. The candidate will provide guidance and leadership to ensure that the quality function maintains the standards expected by global regulatory authorities. This position will report to the SVP, Quality and Regulatory who sits on Alumis’ Executive Committee.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Overall responsibility for the development and implementation of the vision and strategy for the GMP/GLP Quality functions.
• Manage existing high performing team including professional development and coaching, providing support and guidance as needed.
• Act as the technical subject matter quality expert for all matters governed by GMP/GLP related regulations and guidelines as it relates to manufacturing, preclinical, testing and analytical controls.
• Oversee the implementation of GMP/GLP activities as required by internal procedures and application of regulatory requirements.
• Oversee and support activities related to external quality such as, but not limited to, development of process and analytical methods, tech transfers, deviations/investigations, quality agreements, lot dispositions, supplier and contract manufacturing selection and qualifications.
• Oversee management and product review meetings. Provide quality oversight of key CMC and IND enabling documents.
• Represent Quality on project teams, Health Authority Inspections, suppliers and CDMO operational meetings, and QA to QA meetings.
• Collaborate closely with Quality Management Systems (QMS) to ensure effective implementation and integration of quality processes, enhancing compliance and operational efficiency across all stages of product development and commercialization.
• Support SVP Quality and Regulatory with budget creation, goals setting, capacity model, performance evaluation, Quality KPIs and Metrics, Quality Governance, internal audits and key quality initiatives.

EDUCATION & EXPERIENCE

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering or related field.
• Minimum 15 years of GMP Quality Assurance experience.
• Strong understanding of small molecule manufacturing with direct experience in solid oral dosage forms.
• 10+ years of demonstrated experience in leading and managing teams, fostering a collaborative culture, and driving performance excellence in Quality Assurance processes and initiatives.
• Preference for a candidate with proven track record of taking a drug candidate from Phase III through commercialization ensuring compliance with quality standards and regulatory requirements at every stage.
• Extensive experience in developing and scaling Quality Assurance departments, establishing robust processes and systems to enhance overall quality and compliance.
• Hands-on experience in manufacturing and/or analytical testing & development.
• Experience with pre-approval inspections, managing vendors, depth in establishing and maturing departments.
• Experience developing and building out the QA function for commercial stage company.
• Understanding of QP requirements and processes a plus.
• A successful track record working with suppliers and CDMOs.
• In-depth knowledge of cGMP regulations, quality systems, and regulatory requirements applicable to small molecule drug development and commercialization.
• Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.

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.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Some travel required.

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.