Manager/Senior Manager GCP Compliance
- Employer
- Dynavax Technologies
- Location
- Berkeley, CA, US
- Start date
- Dec 27, 2018
View more
- Discipline
- Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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Job Details
Overview
The QA manager position provides QA support and oversight to ensure compliance with Good Clinical Practice (GCP). Areas of responsibility include:
Responsibilities
Qualifications
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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.
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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Company
We are developing immunotherapies based on cutting-edge Toll-like receptor (TLR) biology and its ability to modulate the immune system.
Company info
- Website
- http://www.dynavax.com/
- Mini-site
- Dynavax Technologies
- Phone
- 510-848-5100
- Location
-
2100 Powell Street
Suite 300
Emeryville
California
94608
US
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