Senior Director, Clinical Quality Assurance

Initial Therapeutics, Inc.; South San Francisco (CA); On-site; USD 260,000 - 275,000; Full time

Job summary

An established industry player in precision medicine is seeking a Clinical Quality Assurance Sr. Director to lead quality initiatives for clinical trials. This pivotal role involves ensuring compliance with GCP and GVP standards, overseeing quality assurance programs, and collaborating with various teams to uphold the highest quality standards. The successful candidate will establish key performance indicators and drive a culture of ethics and integrity within the organization. If you are passionate about transforming patient lives and possess extensive experience in clinical quality assurance, this opportunity is perfect for you.

Benefits

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

Kitchen stocked with snacks and drinks

Generous stock option grants

Annual bonus program

Qualifications

• 12+ years of GCP/GVP Quality Assurance experience required.
• Strong understanding of FDA regulations and drug life cycle management.

Responsibilities

• Establish and maintain GCP QA programs and ensure compliance.
• Provide quality oversight for clinical trial documentation and audits.

Skills

Good Clinical Practice (GCP)

Good Pharmacovigilance Practice (GVP)

FDA Regulations

ICH Guidance

Quality Management Systems

Analytical Skills

Collaboration Skills

Communication Skills

Problem-Solving Skills

Education

Bachelor's or advanced degree in Biology, Chemistry, or related field

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 Clinical Quality Assurance Sr. Director, reporting to the SVP of Quality. The role will work closely with the Development leadership and Study Execution Team members to provide GCP/GVP support for all ongoing clinical studies. This involves working closely with Clinical Operations, Clinical Development, Clinical Supply Chain, Medical Affairs, Regulatory, Legal, and other teams across Alumis.

The Clinical QA Sr. Director is responsible to ensure quality is embedded throughout the lifecycle of all the ongoing clinical programs through oversight, assessment and monitoring, risk assessment tools and risk mitigations. The Sr. Director will be responsible to establish Key Performance Indicators and Metrics to trend and track the health of the clinical trials. The role is responsible for providing operational quality guidance for the development teams and supporting the VP of Quality in building the Alumis Quality organization strategy and vision.

This position requires expertise in Good Clinical and Pharmacovigilance Practices (GCP & GVP) and relevant US and EU regulations. 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.

Essential Duties & Responsibilities

• Establish and maintain the GCP QA programs, policies, and procedures.
• Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
• Act as the primary GCP QA subject matter expert and point of contact for all GCP/GVP related matters and issues.
• Establish the study-specific audit plan; perform audits and lead a team of external quality auditors as needed.
• Represent Quality on project teams, Health Authority Inspections, service providers and CROs operational meetings, and QA to QA meetings.
• Manage Quality Review Board meetings content and material. Prepare KPI and metrics.
• Provide quality oversight and review of key Clinical and IND/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
• Determine the strategy for and lead the implementation of inspection readiness plans and activities. Act as the primary liaison with the Health Authority and internal/external business partners.
• Support clinical service provider selection and qualification activities and develop periodic compliance/metric reports.

Education & Experience

• Bachelors or advanced degree in Biology, Chemistry, or related field.
• Minimum 12 years of GCP/GVP Quality Assurance experience.
• Strong understanding of small molecule products with direct experience in solid oral dosage forms.

Knowledge | Skills | Abilities

• Extensive knowledge of FDA regulations and practices, ICH guidance, and strong knowledge of global health authority regulations and practices.
• Hands-on experience in drug life cycle management.
• A successful track record of working with service providers and CROs.
• Ability to make timely and sound quality decisions when faced with complex clinical, compliance, technical and regulatory considerations. Highly skilled in the ability to work with ambiguity and complexity.
• Knowledge of Quality Management Systems; experience in implementing and managing quality systems in the pharmaceutical industry.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills.
• Ability to work with minimal supervision, to set priorities to meet timelines, and to motivate and influence others. Prior management experience is required.
• Previous experience in successfully leading assigned activities within cross-functional teams.
• Some travel is required.

The salary range for this position is $260,000 USD to $275,000 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.