Offers “Roche”

Expires soon Roche

Principal Scientist I, Clinical Quality Assurance

  • Pleasanton (Alameda)
  • Marketing

Job description

  Job facts

Responsibilities:

·  Provide Quality Assurance oversight to clinical operations program.
·  Review of study master files and study investigation files to help ensure compliance to current standard operating procedures and international and US regulations.
·  Represent Quality Assurance in audits/ inspections of clinical trial sites.
·  Review and approval of clinical operations standard operation procedures to help ensure compliance to international and US regulations and divisional and business area standard operating procedures.
·  Represent Quality Assurance in the review of and response to regulatory agencies inquiries and/or deficiencies concerning clinical trial reports/ submissions/ deficiencies.
·  Periodic review of clinical operations training requirements to ensure compliance to current regulations.
·  Represent Quality Assurance in the timely and compliant completion of local CAPA, EQNC and QAR assessments.
·  Provides Compliance guidance and support to local research and development functions.

Qualifications:

·  Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
·  Master's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience is preferred.
·  7 years Development, Manufacturing and/ or Design Quality Assurance experience under established quality regulations, intermediate/advanced knowledge of IVD, Medical Device and/or Pharmaceutical Quality Assurance including but not limited to 21 CFR Part 820 and IVD Directive is preferred.
·  3-5 years working experience in clinical operations.
·  Experience should include trial site selection, preparation and monitoring, protocol and record review, and submission preparation.
·  Working knowledge of Good Clinical Practices including but not limited to ICH Consolidated Good Clinical Practice Guideline
·  Strong track record of successful participation on cross functional technical/ project teams

·  Who we are

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Make every future a success.
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