Dynavax Technologies

  • Senior Manager GCP Compliance

    Job Location US-CA-Berkeley
    Posted Date 3 weeks ago(10/31/2018 12:22 PM)
    ID
    18-085R
    Category
    Quality Assurance
  • Overview

    The QA manager position provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP).  Areas of responsibility include: 

    • Participate in development of Clinical and Clinical QA standard operating procedures (SOPs) and policies;
    • Manage audits of investigator sites, vendors/CROs, trial master files, data/CRFs, and study documents (eg, protocol, clinical study reports) for clinical trials.

    Serve as QA GCP representative at project meetings. 

    Responsibilities

    • Partner with the Clinical Department 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 compliance perspective and provide supervisor with reports of compliance matters.
    • Plan and/or conduct 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.
    • Participate in corporate audits and regulatory authority inspections, project team meetings, and GCP training activities, as required.
    • Represent Clinical QA at meetings, communicating compliance perspectives and risks.
    • Resolves compliance issues and assess impact of any deficits.
    • Serve as process owner for select Clinical QA SOPs.
    • Stay abreast of current regulatory enforcement trends and regulatory changes. Assist with feedback and updates as relevant to SOPs, training, or policy changes to align with regulatory updates.
    • Work with relevant auditees to manage identification of the root cause in Clinical and Clinical QA processes, in order to develop remediation plans and resolve the audit findings and/or significant protocol deviations.
    • Collaborate with external vendors to ensure the quality of services and deliverables.
    • Maintain and track Clinical CAPAs and follow-up with stakeholders for CAPA remediation activities to ensure actions are assigned and completed.
    • Assist the QA management team with all other Clinical QA activities.
    • Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
    • Other duties as assigned.

    Qualifications

    • Proven experience in a Quality environment with hands-on experience related to clinical trials.
    • BS/BA degree in a scientific or health-rated field with 5 plus years’ progressive experience in quality, preferably in Clinical QA, and at least one-year of management experience.
    • Knowledge of applicable FDA, EU, and ICH regulatory requirements for GCP.
    • Computer skills: proficient with Word, Excel, Visio, PowerPoint, and Adobe Acrobat.
    • Excellent written and oral communication skills.
    • Strong to excellent organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail.
    • Must have the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
    • The ideal candidate is highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
    • Position may require up to 25% travel.

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