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Fibrogen
San Francisco, CA, United States
13 days ago
Fibrogen
San Francisco, California, United States
13 days ago

Description



Sr. Manager, Associate Director, Clinical Quality Assurance

Job Number: 2022270

San Francisco, CA

REMOTE WORK APPROVED

Scope of Responsibilities
The CQA Senior Manager/Associate Director will support the implementation and continuous improvement of FibroGen's clinical Quality Management System (QMS) to ensure clinical trials are conducted in accordance with relevant regulations, guidelines, procedures and protocols. The incumbent will be responsible for conducting Good Clinical Practice (GCP) compliance assessments of global investigator sites, vendors, clinical study documentation, and internal systems/processes. The incumbent will interface with both US- and China-based colleagues and provide oversight and GCP compliance advice to clinical study teams during routine and decision-making meetings.

The incumbent must have the ability to execute CQA tasks independently; effectively represent Quality in a cross-functional team setting; and interface with clinical vendors, investigator sites and regulatory agencies in a professional and effective manner. This position requires excellent skills in negotiation, written/verbal communication, and independent problem solving. The candidate must have a solid understanding of the clinical development process and the ability to practically apply domestic and international GCP regulations and guidance. A significant component of this position is providing support to FibroGen studies conducted in China, so the incumbent must have a strong foundation in China local regulations and guidelines.

In addition, the incumbent must actively participate in sustaining a level of inspection readiness of FibroGen's clinical stakeholders and act as a catalyst for continuous process improvement.

Specific Duties:
• Promote the development and improvement of clinical QMS-related processes to ensure compliance with GCP and applicable regulatory requirements and best industry practice.
• Provide quality oversight to ensure global clinical trials are performed in accordance with study protocols and in compliance with Good Clinical Practice and ICH guidelines.
• Lead GCP compliance evaluations of investigator sites, clinical vendors, trial master files, and internal systems/processes, throughout the complete study lifecycle.
• Perform quality reviews of clinical study documents, such as clinical protocols/amendments, informed consent/assent forms, and clinical study reports, to ensure studies are performed in compliance with the protocol, FibroGen processes, GCP, and applicable regulatory requirements.
• Qualify clinical vendors for outsourced activities per CQA's established processes.
• Provide expert advice to internal stakeholders (e.g., Clinical Development/Operations, Data Management, Drug Safety) based on analysis and interpretation of GCP requirements.
• Collaborate with internal stakeholders to identify, mitigate, and document risks associated with study participant safety, data integrity, and GCP/regulatory compliance.
• Deliver comprehensive GCP and inspection training to FibroGen stakeholders and clinical investigators/site staff, as needed.
• Support the preparation (readiness) and management of regulatory authority GCP inspections at FibroGen and/or clinical investigator sites.
• Manage the investigation, documentation (CAPA Plan), and resolution of clinical quality events.
• Support the generation and review of trending data/metrics to identify areas for improvement or potential noncompliance.
• Travel (domestic and/or international) up to 25% of the time (post-pandemic).

Education/Requirements:
• 10+ years experience in the Biotech/Pharmaceutical Industry, preferably for a sponsor company, with 5+ years of demonstrated GCP experience.
• B.S./M.S. in a relevant science field.
• Possess a current and strong working knowledge and interpretation of the United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research, including China.
• Possess excellent verbal and written communication skills, with the ability to work independently, as well as with global cross-functional teams.
• Ability to independently prioritize work, effectively manage multiple projects, and quickly pivot as priorities shift, without compromising on quality or GCP/regulatory compliance.
• A highly diplomatic, tactful, and detail-oriented individual with exceptional critical reasoning skills.
• Ability to deal with ambiguity and develop creative and pragmatic solutions to GCP compliance risk areas.
• Experience supporting regulatory authority inspections is desired.
• Ideal candidate may work remotely but will be expected to travel up to 25% of the time (post-pandemic)
• RQAP-GCP certification is a plus.
• Chinese speaking/writing skills preferred but not required.

FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law. FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

E-Verify: Notice to all Prospective Employees

Notice to Recruiters and Search Firms

FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.

FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.

An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.

To apply, please visit: https://fibrogen.wd5.myworkdayjobs.com/en-US/FibroGen/details/Sr-Manager--Associate-Director--Clinical-Quality-Assurance_2022270?q=2022270






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Job Information

  • Job ID: 63139123
  • Location:
    San Francisco, California, United States
  • Position Title: Sr. Manager, Associate Director, Clinical Quality Assurance
  • Company Name For Job: Fibrogen
  • Org Type: Academic
  • Job Function: Quality
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