Sr. Clinical Quality Assurance Specialist - Contract

Emeryville, CA, United States
Feb 20, 2021
Biotech Bay
Required Education
Masters Degree/MBA
Position Type

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

In this role, which is a 1+ year contract assignment with potential to convert to full-time, you will provide direct support to the Associate Director Clinical Quality Assurance (CQA) in managing compliance related to cGCP, pharmacovigilance and other related activities. The individual will provide compliance support to Clinical Development (Clinical Operations, Data Management, Biometrics Data Science, Safety/PV), overseeing the GCP audit programs and developing, maintaining, and continuously improving the GCP Quality System.

You will provide input and oversight to ensure all documentation, processes and systems meet our compliance requirements and are effectively monitored and maintained. You will use your expertise in FDAs (21 CFR parts 11, 50, 54, 56 & 312) and global compliance standards (ICH- E6 R1 & R2, ICH E2A, E3, & E8) to ensure compliance across and interpret the requirements to Clinical-Ops, Data Management, RA Quality Assurance and Safety/PV department. You will also plan requirements, identify risks, manage schedules, and communicate clearly with all project and clinical stakeholders. In addition, you will:
  • Identify, assess, and advise on compliance risks and controls to a variety of stakeholders and customers.
  • Design Clinical QA folders for all development studies that is easy to navigate and identify.
  • Locate current and archive files from Quality documentation system (VQD-Veeva vault) and file into new filing system.
  • Work on CQA GCP deficient quality documents and resolve outstanding challenges.
  • Create and drive programs to tighten the data security and governance over our internal data.
  • Coordinate, manage, and facilitate compliance processes to provide timely deliverables. Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs
  • Review and approve clinical documents (protocols, ICFs, Monitoring plans, Blind mgmt. plan & eCRF, UATs, etc.)
  • Train and mentor Clinical-ops staff on global GCP regulations and Guidelines
  • Assist on CAPA follow-ups on in-house and clinical site CAPs.
  • Author Clinical Quality plans for the studies.
  • Perform audit of Clinical study reports.
  • Support in Clinical Site holds and for-cause audits.
  • Actively participate in Clinical Operations/Data management meetings and provide timely updates to the department lead.
  • Conduct CROs, Reading labs. Central labs and Investigator site audits
  • Participate in FDA PAI mock inspection audits.
  • Identify Quality and Compliance related issues and implement practical solutions while ensuring timelines are maintained.
  • Conduct QA oversight and audit of eTMFs
  • Assist in the preparation, execution and follow up activities related to internal and external regulatory audits, and inspections.
  • Prepare and conduct external vendor inspections and audits and maintain the schedule or required audits to maintain compliance.
  • Analyzes deviations between SOPs and observed actions and determines if the actions must be corrected or the SOPs must be modified.
  • Creates and updates Standard Operating Procedures (SOP). Provide training and overall guidance to on the clinical affairs organization on compliance requirements.
  • Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
  • Previous experience with regulated global trials preferred. Current and working knowledge interpretation/implementation of government and other local state/government regulations/requirements governing the ability to work in a clinical setting required.
  • Proven ability to manage multiple projects while maintaining quality.
  • Strong interpersonal skills with reputation for collaboration with colleagues.
  • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).
  • Demonstrated success in assisting in solving complex strategies across multiple functions within the department in support of conducting multiple global clinical trials across multiple franchises required.
  • Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions required.
  • Proactive, energetic, Analytical, strategic thinker, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders.

Essential Duties and Responsibilities:
  • Support continuous improvement of quality processes and systems that assure compliance of clinical study-related activities, and in collaboration with contract research organizations and in-house clinical development.
  • Design Clinical QA folders for all development studies that is easy to navigate and identify. Locate current and archive files from Quality documentation system (VQD-Veeva vault) and file into new filing system. Maintained Clinical Quality documentation.
  • Support preparations for and follow-up of effective audits of investigator sites, essential documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, vendors, and internal processes.
  • Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members (attend internal Study Team Meetings and corresponding external study meetings)
  • Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution
  • Support training staff and external partners in compliance, current clinical practices and procedures
  • Maintained annual Internal audit schedule and external Audit Schedule into Annual audit plan. Manages corresponding workflows ensures documentation is maintained per procedures. Assist in vendor audits and CAPA follow-ups and closure.
  • Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
  • Support GCP inspection readiness & Provide in-house GCP training.

  • Bachelor’s degree in a scientific field preferred 6+ years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role (Pharmaceuticals or Biotechnology).
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R1 &R2) for Good Clinical Practice. Experience with all phases of clinical trials
  • Knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11, 50,54,56, & 312 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
  • Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
  • Attention to detail as well as a crisp, clear and concise style in written and oral communications.
  • Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
  • Experience supporting inspection-readiness activities (FDA, HC & EMA) is a plus.

For more information about our company and the work experience, please visit