Associate CQA Director -Temporary

July 24

Apply Now

Receive Emails with Similar Jobs

Alector

WebsiteLinkedInAll Job Openings

We are harnessing the immune system to treat neurodegeneration and cancer.

Biotechnology • Neurodegenerative disease • Neurodegeneration • Immuno-neurology

51 - 200

💰 $133M Series E on 2018-07

Description

• Executes the direction for CQA’s approach in collaboration with the Quality Leadership Team/CQA Management Team and relevant stakeholders. • Directs the development and implementation of this approach to ensure an effective CQA oversight and audit program which complies with regulatory requirements and stakeholder expectations. • Manages the audit program including oversight of Contract Auditors, management of audit plans, reports, and responses, as well as evaluation and refinement of Audit tools and templates (for Clinical Investigator Sites, Vendors, and Internal Audits). • Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors) • Provides QA support to PV for process improvements, compliance initiatives, issue resolution, etc. • Assures the creation and implementation of the appropriate strategic risk-based support model for each program. • Ensures the development of short and long-term risk-based quality strategies in support of development programs based on current regulatory interpretations. • Provides strategic direction to ensure that the appropriate processes and procedures are in place for CQA • Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CQA key stakeholders and development functions. • Support Sponsor GCP Inspection Readiness and Management for Clinical Sites and Sponsor activities including review and staging of regulatory authority expected and actual inspection requests (FDA, EMA, MHRA), organizational preparation activities (mock inspection, storyboarding, etc.) and management of in-process global regulatory authority inspections at Clinical Sites.

Requirements

• Minimum 5 years CQA, preferred 10 years experience in Clinical Quality Assurance • Experience conducting and managing Investigator Site, Vendor, and Internal GCP audits • Experienced in GCP Sponsor and Clinical Investigator Site Inspection Readiness/Preparation • Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations, and procedures • Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations • Practical experience and understanding in GLP and/or GVP • Experienced in SmartSheet and Veeva