Director, Clinical Quality Assurance

2 weeks ago

Santa Monica, United States Neogene Therapeutics Full time

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Position Summary

The Director Clinical Quality Assurance (QA) & Compliance is responsible for ensuring adherence with the GCP quality system's procedures, as well as the identification and assessment of regulatory and quality risks in activities and processes according to regulatory agency guidelines and company standards. This role is accountable for routine execution of Quality Assurance & Compliance duties related to Neogene's clinical development programs, as well as overseeing the development, implementation, maintenance, and performance of the GCP Quality Assurance systems both within Neogene and external vendors. This role is based in Santa Monica, CA, and reports to Sr. Director, Quality located in Netherlands.

Essential Functions and Responsibilities

Act as an integral member of the Quality Management team.

Formulate and execute strategies and roadmaps with the company's Quality Vision.

Collaborate closely with the clinical study management team and the Quality team to provide expert clinical compliance information, address identified issues, and drives continuous improvement.

Maintain up-to date knowledge of relevant regulatory requirements.

Develop interpretation and application of existing and new requirements in conjunction with relevant stakeholders.

Design, implement, monitor and maintain the Quality Management System for GCP.

Leads intra/inter-departmental teams and/or projects aimed at enhancing the GCP Quality Management System through fostering positive change.

Author, review and/or approval of GCP records and documents both internal and external.

Assist in identifying reporting and developing Corrective and Preventive Actions (CAPA) for deviations, in close collaboration with the clinical study team.

Ensure qualification of and maintain oversight over contracts auditors and external vendors.

Spearhead the development of audit strategy plan(s) and ensuring timely execution of plans for programs.

Oversees GCP routine and complex audits including but not limited to investigator/infusion sites, apheresis sites, internal processes, and vendors.

Ensure training plans are in place in collaboration with functional line managers.

Provide effective compliance reporting to senior management and relevant governance forums.

Assume leadership role in managing of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.

Offer support regulatory agency inspections, internal and external audits, as needed.

Cultivate a commitment to quality within individuals and foster a culture of quality within the

Fulfill other duties as assigned.

Required Skills/Abilities

Proficiency of and ability to apply GCP in accordance with US, EU and Rest of World (ROW) standards.

Extensive expertise in GCP regulations, quality systems and regulatory requirements.

Demonstrated experience in Clinical QA & Compliance and GCP audit processes.

Proven track record of managing clinical trials.

Self-driven, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Acknowledged as authority in the realm of Clinical QA and Compliance field.

Adept at effective negotiation and fostering collaboration among diverse individuals.

Willingness to innovate and adapt best practices to suit the specific needs of the product.

Capable of managing multiple projects simultaneously showcasing organizational prioritization and time management skills.

Comfortable in a dynamic small company setting, able to work independently, and flexible in responding to changing priorities.

Education and Experience

Bachelor's Degree and 12+ years' experience OR Master's Degree and 10+ years' experience OR Ph.D. Degree and 8+ years' experience in a GCP/GMP environment.

Proficient in composing, assessing, and concluding investigations, Corrective and Preventive Actions (CAPAs), and change control records.

Proficiency in overseeing and conducting both internal and external audits.

The anticipated salary range for candidates who will work in Santa Monica, CA is $170,000 to $200,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At this time, Neogene is not sponsoring VISAs.

Neogene Therapeutics requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

DE&I Statement

Headline:

We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view

A collaborative culture that leverages the diverse perspectives of employees and supports courage

Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist."

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