The client is a biopharmaceutical company in the late stages of development, dedicated to discovering and creating innovative treatments for fibrotic diseases. As a leading force in the development of novel therapies for fibrotic diseases, the client focuses on creating small molecule drug candidates specifically designed to target and influence the fibrotic process.
Time: 20-30 hours a week to start. - 6 month contract with possibility of extension.
Pay rate: $180-215 Per hour
W2 Contractors
2x per week on site in greater San Francisco
Description
The Associate Director/Director of Clinical Quality Assurance (CQA) is a hands-on role responsible for ensuring that client-sponsored clinical trials adhere to applicable Good Clinical Practice (GCP) regulations (e.g., FDA, international, and country-specific), ICH guidelines, the client's Standard Operating Procedures (SOPs), and current industry standards. The candidate will support clinical compliance and readiness for inspections, reporting to the Senior Director of CQA.
The Director of CQA must excel in a fast-paced, innovative environment, remaining adaptable, proactive, resourceful, and efficient. Strong interpersonal skills, the ability to build relationships with key stakeholders, good negotiation skills, and the ability to analyze issues to support relevant and realistic plans are essential. The candidate must demonstrate the ability to translate strategic and tactical decisions into action, possess excellent analytical skills, and develop plans to resolve issues and mitigate risks.
This hybrid role requires three days per week at the client's office in South San Francisco.
Responsibilities
- Represent clinical quality at program team meetings and provide operational quality guidance to the development teams.
- Participate in CROs operational meetings, service provider meetings, and vendor quality meetings.
- Provide quality oversight for ongoing clinical programs, ensuring appropriate assessment, monitoring, risk assessment, and risk mitigation.
- Review clinical trial documentation for data integrity and compliance with Good Clinical Practice and regulations, including key clinical and IND/NDA enabling documents.
- Support Health Authority Inspections, service providers, CROs operational meetings, and inspection readiness activities.
- Collaborate with Clinical Development (including PV/Safety), Regulatory Affairs, Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs, and clinical sites to support overall GCP compliance and inspection readiness.
- Manage a risk-based clinical Quality Management System (QMS) for GCP QA in compliance with applicable regulatory requirements (U.S. and international) and company policies.
- Provide compliance advice and guidance to achieve continuous quality improvement and effective quality assurance, fostering a culture of continuous improvement with an emphasis on efficiency and effectiveness.
- Support the implementation of internal standards, policies, and procedures to ensure compliance, including co-authoring and reviewing Standard Operating Procedures.
- Develop and implement study-specific audit plans, annual audit schedules, and periodic compliance/metric reports.
- Assist in selecting clinical service providers and conducting qualification activities.
- Manage quality event management for assigned clinical programs and studies, including root cause assessment and CAPA (Corrective and Preventive Actions) oversight.
- Oversee GCP training, including developing and revising training matrices and training new GCP personnel.
- Conduct or support GCP, GCLP, GLP, and GVP audits of clinical investigator sites, CROs, contract clinical laboratories, and processes/systems to determine compliance status, including support of contract GXP auditors performing various GXP audit types.
Qualifications
To perform this job successfully, the candidate must meet the following requirements:
- A Bachelor's degree with 12 years of experience, or an advanced degree in a scientific field with 10 years of experience (preferred). Quality assurance professional certification is a plus.
- A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice. Experience with all phases of clinical trials.
- Knowledge and practical application of ICH E8 (R1).
- Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines, including an understanding of domestic and international regulatory requirements.
- Experience with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).
- Familiarity with phase-appropriate procedures, processes, and data integrity controls.
- Experience interacting with domestic and international clinical service providers for early to late-stage clinical trials.
- Proven industry success, including experience in regulatory inspection preparation and supporting inspections.
- Experience with the audit process, including auditing clinical sites and clinical service providers (preferred).
- Experience with Pre-Approval Inspection readiness activities such as creating storyboards, using inspection electronic management systems, conducting mock inspections, and preparing clinical study sites.
- Clinical Quality Auditor certification is a plus.
- Some travel may be required.
- Ability to operate in alignment with the client's values and culture.
Compensation
The Pay rate: $180-215 Per hour. Individual pay may vary based on job-related skills, experience, work location, and relevant education or training. The client’s compensation package also includes benefits, equity, and an annual target bonus for full-time positions.
