Senior Manager GCP Compliance

Location
Berkeley, CA, US
Posted
Nov 01, 2018
Ref
18-085R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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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