- Drive strategy and roadmap in support of the company's Quality Vision.
- Works closely with the clinical study management team and the Quality team to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Responsible for developing interpretation and application of existing and new requirements in conjunction with relevant stakeholders.
- Design, effective implementation, monitoring and maintenance of the Quality Management System for GCP.
- Authoring, review and/or approval of GCP records and documents (both internal and external).
- Support deviation identification, reporting, and CAPA development in close collaboration with the clinical study team
- Oversees GCP 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.
- Effective compliance reporting to senior management and relevant quality governance forums.
- Support regulatory agency inspections, internal and external audits, as needed.
- Proven prior experience working on the sponsor side of Clinical Quality Assurance.
- Perform other duties as assigned.
- N/A
- Knowledge of and ability to apply GCP in conformance to US, EU and Rest of World (ROW) standards.
- Demonstrated experience in building, managing and leading Clinical QA teams.
- Demonstrated knowledge in GCP regulations, quality systems and regulatory requirements.
- Clinical QA, GCP audit an clinical trials management.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Understanding of the principles of quality management, risk assessment, and compliance within the clinical trial e
- Background in Cell Therapy/Biotech industry and / or Oncology field.
- 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.
- 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
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Director, Clinical Quality Assurance - Santa Monica, United States - Neogene Therapeutics
Description
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 of Clinical Quality Assurance (QA) & Compliance is tasked with ensuring adherence to the GCP quality system's procedures. They are also responsible for identifying and evaluating regulatory and quality risks in activities and processes, in alignment with regulatory agency guidelines and company standards. This position holds responsibility for overseeing Quality Assurance & Compliance tasks associated with Neogene's clinical development programs. It entails supervising the development, implementation, maintenance, and efficacy of GCP Quality Assurance systems both within Neogene and with external vendors. Located in Santa Monica, CA, this role reports to the Senior Director of Quality.
Essential Functions and Responsibilities
Supervisory Responsibilities
Required Skills/Abilities
Education
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:
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."
Director, Clinical Quality Assurance professionals in Santa Monica
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Simon Wannehag Hagene
Creative Writer | QA | Localization | Filmmaker
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Chinedu Amadi
Copywriter