Clinical Quality Assurance Specialist

4 weeks ago

South San Francisco, California, United States Cytokinetics Full time

About Us


Cytokinetics is a leading biopharmaceutical company specializing in the development of innovative muscle activators and inhibitors for the treatment of debilitating diseases affecting cardiac muscle performance. With a strong foundation in muscle biology and mechanics, our company is dedicated to delivering cutting-edge treatments that improve patient outcomes.


Job Summary


We are seeking an experienced Clinical Quality Assurance Specialist to join our team. As a key member of our regulatory compliance team, you will be responsible for ensuring the highest standards of quality in our clinical research operations. The ideal candidate will have a strong understanding of FDA and European regulations, as well as experience in conducting clinical trials and audits.


Key Responsibilities


This role involves:



  • Regulatory Compliance: Ensure compliance with FDA and European regulations, including ICH guidelines, to maintain the integrity of our clinical research operations.
  • Quality Assurance: Conduct audits and inspections to verify the quality of our clinical studies and ensure adherence to Good Clinical Practices (GCP) and study protocols.
  • Audit Planning and Execution: Plan, conduct, and report on audits of clinical sites, vendors, and internal functional areas to identify and address any compliance issues.
  • GCP Training: Provide training and support to internal staff on GCP and Inspection Awareness/Readiness to ensure they are equipped to handle regulatory inspections.
  • Regulatory Inspections: Support GCP and Drug Safety/Pharmacovigilance (DS/PV) related regulatory inspections at Cytokinetics and assist clinical sites in preparing for inspections.

Requirements


To be successful in this role, you will need:



  • Education: A Bachelor's or Master's degree in science, nursing, or a related field, with a minimum of 6 years of experience in clinical research and quality assurance.
  • Experience: A minimum of 3-5 years of experience working in FDA-regulated clinical research, including at least 1-3 years of experience in Clinical Quality Assurance.
  • Regulatory Knowledge: A working understanding of FDA and European regulations and guidance, including ICH, and the ability to apply this knowledge to ensure compliance.
  • Communication Skills: Excellent interpersonal and communication skills, with the ability to clearly discuss audit findings and provide quality deliverables.
  • Technical Skills: Experience with conducting clinical trials and audits, and proficiency in creating audit plans, conducting audits, and generating audit reports.

What We Offer


Cytokinetics offers a competitive salary range of $150,000-$166,000 USD and a comprehensive benefits package, including health insurance, retirement plans, and paid time off. We are an equal opportunity employer and welcome applications from diverse candidates.


About the Location


Cytokinetics is based in the United States, and this role will be based in our [location]. We offer a unique culture and a competitive benefits program, making us an attractive employer for top talent in the biopharmaceutical industry.


How to Apply


If you are a motivated and experienced Clinical Quality Assurance Specialist looking for a new challenge, please submit your application, including your resume and a cover letter, to our website at www.cytokinetics.com. We look forward to hearing from you


Cyokinetics is an Equal Opportunity Employer

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