Associate Manager/Manager GCP Compliance - Berkeley, CA | Biospace
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Associate Manager/Manager GCP Compliance

Dynavax Technologies

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Location:
Berkeley, CA
Posted Date:
7/29/2017
Position Type:
Full time
Job Code:
17-007R
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Compliance, Manager,

Job Description


As a member of the Quality Assurance team, provide Clinical Quality Assurance (CQA) support to Clinical Development activities to ensure compliance with Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP).

Areas of responsibility include:

Provide Clinical Quality Assurance for Clinical functional areas.
Manage and/or conduct audits of clinical investigator sites, clinical service providers and study documents (e.g., protocol, clinical study reports, Investigator Brochure, etc.) for clinical trials. Support the resolution of audit findings, track/trend CAPAs, monitor CAPA effectiveness.

Lead internal and external investigations within area of functional responsibility.

Serve as CQA GCP representative at project meetings, providing GCP compliance advice, depending on the position level.

Assist with development Clinical and Clinical QA operating procedures to support continuous process improvement.

Support regulatory authority inspection activities.

Requirements


Partner with Clinical Development to ensure all clinical trials are assessed for compliance with applicable operating procedures, regulations and ICH/GCP guidelines.

CQA point of contact for study/project specific responsibilities, participant at relevant meetings.
May review departmental procedures and clinical documents from a GCP/GVP compliance perspective.

Plan and/or conduct audits of clinical investigator sites, clinical service providers, clinical documents and relevant internal systems. If required, partner with consultants on audit activities.

Participate in and support internal audits and regulatory authority inspections, as required.

Demonstrate knowledge of applicable clinical trials regulations, applying applicable FDA, EU and ICH regulatory requirements for GCP/GVP activities.

Assess the impact of any non-compliance and provide reports of potential compliance risks.

Communicate potential compliance risks openly and effectively across the functional areas and assist in effectively resolving them.

Follow current regulatory enforcement trends to ensure clinical trials meet global standards. Provide feedback and updates, as applicable, to SOPs, training materials, policy changes to align with regulatory updates and business needs.

Maintain and track Clinical CAPAs, including follow-up with stakeholders on CAPA remediation activities to ensure actions are assigned, carried out and completed.

Serve as the CQA process owner for select Clinical Quality Assurance SOPs.

Build and maintain strong relationships within and across relevant functional areas (for example Quality Assurance, Data Management, Drug Safety, Clinical Operations, Regulatory Affairs, Supply Chain).

Supports the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Position may require up to 25% travel.

Perform other duties as required.

Education:

BS/BA degree in a scientific or health-rated field with 5 years’ progressive experience in quality/compliance function with a minimum of 2 years direct GCP experience are required
Proven experience in a quality/compliance function, with hands-on experience related to clinical trials and audits.
Knowledge of applicable US FDA, EU and ICH regulatory requirements and guidelines as applicable to clinical research.
Excellent written and oral communication skills.
Strong organizational skills, with 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.
Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.

Proven ability to influence people at different level of organization.

Experience with health authority inspections and inspection readiness activities.

Computer skills: MS Word, Excel, PowerPoint, Microsoft Project, Visio.