Associate Director, Pipeline Quality Assurance
19 hours ago
We are seeking an experienced Associate Director, Pipeline Quality Assurance to join our team. In this role, you will be responsible for directing all quality-related activities and processes for a pipeline product in clinical phase studies.
Key Responsibilities- Establish and maintain a risk-based and scientific-based quality system and decision-making process.
- Audit manufacturing facilities of vendors, customers, and outside contract organizations.
- Facilitate and approve Quality Technical Agreements with vendors.
- Ensure phase-appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
- Apply phase-appropriate GMP compliance principles to quality decisions.
- Lead investigations, CAPAs, deviations, and quality events to resolution and closure.
- Transition phase 3 clinical stage material to commercial success.
- Manage the quality aspects of a large scope phase 3 clinical project from raw materials to manufacturing to packaging, distribution, and release.
- Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate.
- Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on-time delivery of approved materials.
- Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function.
- Support and train other staff members to develop additional auditing resources.
- Act as the company's representative during regulatory agency and customer inspections.
- Identify and lead operational excellence initiatives, both in the department and company-wide, which result in the overall improvement in both areas.
- Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
- Minimum BS degree in Chemistry, Life Science, or related discipline plus 10 years of experience. OR Masters, PHD, MBA, and 7 years of experience preferred.
- Full understanding of cGMPs, GLPs, and a working knowledge of GCPs.
- Understanding of device regulations and development processes.
- Familiarity of pharmaceutical product manufacturing processes.
- Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs, and MAAs.
- Experience with effectively managing FDA inspections, working with regulators, and customer audits.
- Experience with writing manufacturing and lab investigations.
- Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals.
- Demonstrate ability to manage staff and projects (direct and indirectly) and variable workloads.
- Competitive compensation package including bonus.
- Stock options and RSU awards.
- Employee Stock Purchase Plan (ESPP).
- Flexible Vacation Policy.
- Generous paid holiday schedule and winter break.
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