Dynavax Technologies

Manager/Senior Manager GCP Compliance

Job Location US-CA-Berkeley
Posted Date 1 month ago(1/22/2018 6:36 PM)
ID
18-008R
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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed