Astellas Pharma Manager/Senior Manager, Quality Assurance in Seattle, Washington
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Manager/Sr. Manager Quality Assurance opportunity in Seattle, WA.
Purpose & Scope:
The primary purpose of the Sr. Manager, Quality Assurance & Systems is to develop and oversee a wide variety of activities to ensure compliance with applicable regulatory requirements and Astellas Quality Objectives for high quality / compliant raw materials and early phase CTM products being developed, manufactured, tested, packaged, labeled and distributed. The department is responsible for developing, reviewing and approving Standard Operating Procedures, Batch Records, Process Support Documentation & Training Materials and with management guidance, develop and progress QA activities for the identification and resolution of critical issues through risk management This position will have opportunities to integrate compliance initiatives cross-functionally, provide ownership for internal processes and identify areas for quality improvements. Serves as QA representative on assigned project teams to provide direction regarding quality and compliance, to escalate compliance issues to management and to oversee completion of quality related action items.
Essential Job Responsibilities:
- Provides leadership and training to Quality Assurance Department
- Oversees the QA Program and ensures compliance with Astellas QA guidelines, to include (but not limited to) document control, lot disposition, incident management and material management.
- Manages the Universal Cells Deviation Program. Authors, assists with, reviews, and/or approves completed investigations. Ensures CAPAs are appropriate and effective.
- Manages the Change Control program for processes, facilities, equipment, and software, as needed.
- Authors, revises and reviews SOPs required to maintain the Quality Management System.
- Drafts Batch Records, Standard Operating Procedures, Forms/Templates, Process Support Documentation & Training Materials to support cell manufacturing, testing, packaging, labeling and distribution in support of on-time delivery of QA deliverables
- Edits documentation for clarity, consistency, organization, and effectiveness
- Works directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation
- Successful use of experience and knowledge in developing approach for managing multiple areas of responsibility. Has developed / executed quality strategies with management guidance.
- Leads customer meetings and identifies required potential changes to documentation, takes meeting minutes and communicates status to cross-functional audiences
- Develops training materials, generates document solutions for optimization and risk mitigation, creates improved communication mechanisms
- Performs other duties as assigned or special projects as needed
- Direct impact on the company's Quality Systems
- Reports to Sr. Leadership Team Member
- Collaborates regularly with Production and R&D teams
- BA/BS 6+ years related experience, Advanced degree with 4+ years related experience
- A minimum of 3-5 years related Quality Assurance experience in biopharmaceutical industry (in biologic, cell therapy, stem cell or gene therapy manufacturing) in either CMC, GMP, GCP, Process Validation, or QA.
In-depth knowledge of GMPs relating to product development and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends, cell and or gene therapy area of focus preferred.
- Strong leadership skills and strategic problem-solving ability
- Negotiation and strong persuasive abilities, diplomacy and positive influencing abilities
- Independently make and communicate to stakeholders difficult quality & compliance decisions that integrates input from stakeholders required
- Expert document editing skills, including a real passion for terminology and an eye for missing details
- Project management skills (including the ability to clearly generate project deliverables, timelines and status updates for project stakeholders)
- Ability to explain and interpret information from internal and external sources
- Ability to think quickly and perform complex tasks
- Ability to write in a technical tone
- Cross-functional communication skills and positive attitude with customer service focus
- Strong organizational, time management, and problem-solving skills
- Ability to work independently with supervision and ability to effectively collaborate with other teams
- Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment
- GMP/GLP experience preferred
- Quality Audit experience preferred
- Strong understanding of laboratory systems/equipment (e.g., IQ/OQ/PQ)
- Familiarity with electronic databases (for example: EDMS, SharePoint, Trackwise)
- Experience writing Standard Operating Procedures and Production Batch Records
- Biology or Bio-engineering background related to stem cell culturing, plasmid and rAAV production and product development is preferable
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Quality Assurance/Quality Control