Associate Director, Quality Assurance
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza Pharma & Biotech has an opening for an Associate Director within the Quality Assurance team in their Bend, OR location.
We're looking for an Associate Director with deep subject matter expertise and a strong track record as a people leader who wants to bring their outstanding problem-solving skills into a fast-paced and driven environment.
Key responsibilities:
- Manage and oversee assigned aspects of the Quality Assurance Management System
- Responsible for the master planning and monitoring of the Site Quality Systems and provide point of contact for Quality Assurance groupm for the site
- Assure that execution of investigations, changes, and corrective and preventive actions meet corporate, site, and regulatory requirements.
- Generate, review and approve site documentation, validations, protocols, and quality system documents.
- Manage Quality Assurance teams at the site.
- Direct involvement with client and regulatory agency audits, when required.
- Perform document generation, coordination of protocol routing and approval, and handling of discrepancy reports.
- Review and approve Installation Qualification, Operational Qualification and Performance Qualifications per Company guidelines in accordance with schedule.
- Coordinate and communicate with clients, system owners, and project management of protocol activities and status on a frequent basis.
- Lead / facilitate development of sound risk-based strategies and plans that provide adequate consideration to business and technical drivers.
- Provide discrepancy reporting and investigational support, perform data tabulations and analysis, maintain detailed protocol status and metrics and manage project timelines.
- Execute quality and support operational excellence projects.
- Implementation of corporate quality systems and activities
Key requirements:
- BS in related engineering discipline or related health science
- 10 years of experience with a quality organization or related position in pharmaceutical or related industry
- Commercial pharmaceutical manufacturing experience required.
- 5 years as a Quality Assurance Manager or related position
- Experience with FDA CFR Parts 11, 210, 211 and 820 quality management processes, procedures and qualification
- GMP experience required.