Director, Quality Assurance - Clinical

Director, Clinical Quality Assurance
 

Summary:
We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Clinical Quality Assurance will provide internal and external leadership for the Tricida clinical development team through subject matter expertise, audits, and implementation of associated strategies to ensure compliance with applicable FDA and international standards, regulations and guidelines.

RESPONSIBILITIES INCLUDE:

• Develop and implement processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards in support of the clinical development program
• Develop solutions to complex quality issues and work closely with senior management to prevent and resolve significant compliance issues
• Oversee GCP Quality Assurance programs for clinical trial execution and reporting
• Develop and facilitate GCP training for functional areas and personnel involved in the execution of clinical trials
• Plan and manage GCP compliance audits, including but not limited to clinical investigator sites, contract clinical laboratories and CROs to determine compliance status and identify compliance risks
• Manage the preparation of audit reports and report audit findings to management with recommendations for resolution. Verify appropriate corrective actions have been implemented and documented
• Lead strategic Clinical QA planning and risk assessment; manage CAPA plans
• Participate in the evaluation, qualification and selection of CROs and other clinical service providers; establish quality agreements with clinical CROs
• Provide GCP-related subject matter expertise/guidance to the company through review of essential documents (e.g., protocols, amendments, case report forms, tables and listings, informed consent forms, investigator brochures, and Clinical Study Reports) and regulatory submissions, as requested
• Lead inspection readiness activities. Participate in regulatory authority inspections and collaborate with Regulatory for interactions with agencies on GCP-related matters and preparation of responses to address inspection findings.

EXPERIENCE AND SKILLS:

• Bachelor’s degree in a scientific discipline, minimum 10+ years of experience in Clinical Quality Assurance
• Strong working knowledge of Good Clinical Practices (FDA/ICH), 21CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
• Prior experience performing clinical-related audits and leading inspection-readiness activities
• Demonstrated ability to manage tasks and variable workloads with demanding timelines
• Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution
• Must have excellent verbal and written skills
• Strong organizational and management skills
• Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management
• Position will require travel

Competitive Compensation and Benefits include:
Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will also be provided according to company practice.

Tricida is located in South San Francisco, CA. and this is an on-site position