Dynavax Technologies

Specialist – Senior Specialist, Quality GCP Compliance

US-CA-Berkeley
1 week ago
ID
17-053N
Category
Quality Control/Assurance

Overview

This QA position is a member of the Quality team and provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP), Pharmacovigilance Practices (GVP). In addition, support to the GLP and GMP areas will be provided as needed.

Areas of responsibility include:

  • Coordinate, contribute to and support development and roll out of Clinical, Drug Safety, and Clinical QA standard operating procedures (SOPs); and GLP and GMP SOPs as needed.
  • Coordinate and support audits of domestic and international clinical investigator sites, clinical service providers/CROs, trial master files, data/CRFs, and study documents (e.g., protocol, clinical study reports) for clinical trials.
  • Serve as QA GCP representative at designated project meetings.

Responsibilities

  • Partner with the Clinical Department, Drug Safety, Supply Chain and Commercial Operations to ensure all clinical trials are assessed for compliance with SOPs, FDA and other applicable regulations, and ICH/GCP guidelines.
  • Review departmental procedures and clinical documents from a GCP, GLP and GMP perspective, as needed, compliance perspective and provide management with reports of compliance matters.
  • Coordinate audits, including external vendors, trial master file, clinical investigator sites, clinical documents and other internal systems.
  • Communicate effectively with professional staff and management across departments on compliance and Quality issues.
  • Support and participate in corporate audits and regulatory authority inspectionsand GCP, GLP and GMP training activities, as required.
  • Represent Clinical QA at relevant meetings, communicating compliance perspectives and risks.
  • Assist in investigation and resolution of compliance issues and their impact.
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  • Stay abreast of current regulatory enforcement trends and regulatory changes, and ensure feedback to and updates of relevant SOPs and/or training material.
  • Coordinate and collaborate with external vendors to ensure supplier qualification of services and deliverables.
  • Maintain and track Clinical CAPAs to ensure timely CAPA activities remediation and completion.
  • Maintain a work environment focused on quality, fostering respect, open communication, collaboration and teamwork.
  • Other duties as assigned by QA Management.

Qualifications

  • Proven experience in a Quality environment with hands-on experience related to clinical trials.
    • The Specialist will have at least 5 years of progressive experience in the pharmaceutical and/or biotechnology industry.
    • The Senior Specialist will possess 8 years’ related experience.
    • Consideration can be given to Clinical Research Associate II or Senior Clinical Associate if position requirements are met.
  • BS/BA degree in a scientific or health-rated field.
  • Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP, GLP and GMP.
  • Computer skills: Proficient with Word, Excel, Visio, PowerPoint, Microsoft Project and Adobe Acrobat.
  • Excellent written and oral communication skills.
  • Excellent organizational skills and the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
  • Ability to proactively resolve issues in a diplomatic, flexible and constructive manner.
  • The ideal candidate is highly ethical, self-motivated and works independently and in a team, using quality mindset judgment.

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