Astellas Pharma Associate Quality Systems Document Control Manager in Northbrook, Illinois
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 an Associate Quality Systems Document Control Manager opportunity in Northbrook, IL.
Purpose & Scope:
Primarily responsible for supporting the establishment and administration of a Quality Assurance (QA) document records program, which consists of a systematic approach by which internal and external records received from customers and stakeholders are properly assessed, reviewed, controlled, distributed, retained and archived. Responsible for identifying and supporting a process for the life cycle management of QA documents and records (e.g., tracking system administration, filing, archiving and retention of QA documents). These documents, and proper retention thereof, must meet global regulatory requirements (i.e., cGMP, GLP, GCP, electronic records and signatures). Leads QA continuous improvements for documentation processes/projects which may have impact on multiple departments.
Essential Job Responsibilities:
- Administers the document control program within QA, which includes establishing metrics (applying trends) for customer and quality optimization. Interacts cross functionally with peers and management staff to effectively make decisions regarding document management and review. Delegates and sets priorities, with the manager's guidance, based upon criticality and importance within the department and as part of the company's overall directive
- Maintains a central repository for all QA controlled documentation and coordinates processes for documents received from internal customers, Astellas entities and external companies. Performs quality risk assessment and ensures compliance with established retention schedules. Supports the managing, assigning and prioritizing the document distribution activities to the appropriate QA personnel.
- Creates procedures required for the documentation processes within QA to ensure compliance with global and regulatory standards for a modern quality system. Supports the establishment and determination of record retention for QA documents/records, ensuring compliance with established regulations and procedures.
- Facilitates the effective processing of all critical QA documents/records to ensure they are maintained in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body. Assures compliance with SOPs and regulatory requirements.
- Utilizes technical skills and tools to effectively identify issues, evaluate risk and facilitate appropriate solutions to management.
- Collaborates with cross functional departments and external entities to ensure proper tracking, review and approval of quality documents. Trends and generates Quality metrics for QA Management review.
- Effectively researches and supports continuous improvement in QA processes or systems related to document management and which can impact other departments.
- Conducts orientation and in house, site specific training on Quality documentation SOPs and relevant QA systems/ processes. Develops, maintains and deliver training materials.
- QA notification and enhancements of the department's knowledge of quality systems and strategies.
- Supports the establishment/implementation of Quality system documents and regional quality standards, as needed.
- Bachelor's degree or equivalent with 5 years of industry experience and 2 years of QA experience.
- Must demonstrate effective communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.
- Detailed knowledge of GXP regulations, other quality principles and applies current interpretations/trends to Quality documentation and record control.
- Ability to generate SOPs related to critical QA processes.
- Must demonstrate ability to manage projects independently, with limited management oversight.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical and Research Quality Assurance (CRQA)