Astellas Pharma Senior Manager, Quality Technology, Biologics and New Modalities 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 a Senior Manager, Quality Technology Development Product or Biologics and New Modalities opportunity in Northbrook, IL.
Purpose & Scope:
This position is responsible for facilitating and implementing the Quality Technology strategy to ensure high quality / compliant products are being developed, validated and commercialized in both regional and global settings. The position provides QA oversight and quality services for manufacture, testing, packaging, labeling and distribution of CTM and for the execution of validation and other commercial readiness activities. With management guidance, progresses QA activities and develops processes for the identification and resolution of critical issues through risk management. 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:
- Manages overall GMP QA support activities for multiple projects requiring Clinical Trial Material and/or Commercial Readiness support for the manufacturing, packaging, labeling and distribution for regional and global Astellas products in the development phase through commercial launch.
- Responsible for the timely review and approval of Third Party Manufacturers (CMOs), technical documents (PPQ and GMP CTM Documents) and process related deliverables/changes mainly for biologics, cell therapy and new modalities and/or small molecule developmental compounds.
- Supports supplier issue resolution, by providing product specific knowledge/understanding. With management guidance, supports the development and implementation of quality strategies associated with CTM QA and PPQ (Process Validation).
- Executes CMO (supplier) audits and mock PAI audits related to new product introductions and new Supply Chain initiatives. Supports the CMO during regulatory authority inspections specific to the product/project.
- Promotes cohesive coordination and communication across functional areas in support of on-time delivery of new product launches.
- Supports both regional and global new product introduction initiatives and responsible for building strong relationships across multi-functional disciplines.
- Serves as global QA representative on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
- Evaluates and manages development and/or implementation of local and global process improvement within Quality Assurance. Provides GMP and process improvement guidance to Pharmaceutical Technology Management and other key stakeholders for processes governed by regulatory compliance requirements throughout the product development lifecycle.
- Establish standards in support of quality systems and interfaces across multiple departments and levels of management. Authors/ revises departmental Quality System Documents as necessary. Participates in the biennial review of Quality System documentation.
- Participates in Astellas Quality meetings (Regional and Global) and communicates with appropriate QA personnel or key stakeholders regarding project specific information. Provides direction for developing best practices and process improvements for project success.
Responsible for providing QA support throughout the product development lifecycle from early phase CTM to Commercial Readiness and Product Launch. Responsible for promoting regulatory compliance throughout the product development lifecycle by managing local and global cGMPs, Astellas standards and policies and process improvement initiatives. Provides Quality operational leadership in driving a consistent approach to GMP compliance related to global supply of CTM and PPQ strategy to support Astellas clinical studies and commercial product launch.
This position reports directly to the Associate Director or Director of Quality Technology. This person will be responsible for providing day-to-day QA oversight and resources required to facilitate compliant CTM and Commercial Readiness execution for manufacturing, testing, packaging and Process Validation (PPQ) activities.
As such, this position will work closely with Astellas CMC Labs (BTL, PRTL, PCL, ARL etc.), Product and Process Management, Supply Chain and Clinical Packaging groups to ensure a Clinical Trial Material and PPQ batches are manufactured, labeled, packaged, distributed and stored consistent with global current Good Manufacturing Practices. This position will also work closely with internal Astellas Quality groups to facilitate global launch activities and CTM release to support clinical trials.
- BA / BS in a science or engineering related field, with a minimum of 6 years of pharmaceutical industry experience (in biologic, cell therapy or parenteral manufacturing) in either CMC, GMP, GCP, Process Validation, QC and/or QA.
- Requires approximately 25% travel.
- 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.
- Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Astellas groups and with external stakeholders.
- GMP auditing experience required. Ability to represent Astellas to external stakeholders during vendor audits and during interactions with regulatory agencies.
- Experience in a pharmaceutical manufacturing or clinical development environment preferred.
- Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
- Has effectively applied industry knowledge and interpretation to anticipate global impact and
- contribute ideas for strategies and tactics to ensure adequate long term planning for the Quality
- Assurance function.
- Successful use of experience and knowledge in developing approach for managing multiple
- areas of responsibility. Has developed / executed quality strategies with management guidance.
- Can make decisions for the department in his/her area of quality expertise with limited management oversight.
- In-depth knowledge of global industry standards and regulatory requirements (US, EU and Japan)
- Direct experience in Commercial Readiness (PPQ, Cleaning Validation, Analytical Validation)
- Direct experience in CTM QA.
- Applied knowledge in Biologics, Parenteral, Medical Device, Combination Products and/or Regenerative medicines or new modalities
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Assurance/Quality Control