Astellas Pharma Associate Director, Quality Engineer 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 Director, Quality Engineering opportunity in Northbrook, IL.
Purpose & Scope:
This position is responsible for all aspects of cGMP and related systems and processes supporting development, commercialization and Disposition of Combination Products and Medical Devices including software registered as a Medical Device. This person will act as a Quality Ambassador focusing and influencing development Partners and Contract Manufacturing Organizations (CMO's) to comply with Astellas quality standards, policies and industry cGMP requirements. This position will serve as the main point of contact between Astellas and external Development Partners and CMO's for quality issues. This position communicates potential risks (e.g. Significant Quality Incidents (SQI) to senior management for appropriate action in collaboration with colleagues and affiliates for global programs in the area of responsibility.
Essential Job Responsibilities:
- Develops risk based quality strategies and priorities for short- and long-term development and commercial objectives for Combination Products and Medical Devices to fulfill regional and global regulatory requirements. Provides guidance to both Quality Assurance and other functional areas to ensure processes comply with established standard operating procedures (SOPs) and regulatory requirements including regulatory authority inspection support for contract manufacturers.
- Directs implementation of quality systems and processes associated with assessment of contract manufacturers, partners and internal Astellas responsibilities for Combination Products and Medical Devices. Identifies gaps in Quality Systems and partners with internal stakeholders to identify and implement resolutions.
- Responsible for oversight and management of Commercial Combination Products and Medical Devices as assigned, including developing and supporting the use of a risk based approach for management of product evaluation and disposition activities. Initiates Significant Quality Incident (SQI) records as directed as well as orchestrating REC and MRB activities for Combination Products and Medical Devices related issues when instructed. Provides risk assessments and quality recommendations to those Committees in order to characterize risk for products.
Manage and execute QA activities for Combination Products and Medical Devices under the development stage as follows:
Provide QA oversight for manufacturing, testing, packaging, labeling and distribution of development stage compounds.
- Execute CTM release for clinical studies or support the responsible person / Qualified Qerson (QP) for CTM release.
- Support supplier qualificaition (audits) and provide oversight and issue resolution strategies to suppliers under development and commercialization stage.
- Support RECs, Deviations, Complaints, Quality Agreements, Management Review for development programs.
- Responsible for PAI Readiness for development products and Commercial Readiness including PPQ strategy support, Mock PAI, PAI/PLI and transfer to Quality Operations (First of Code), as appropriate.
- Support Due Diligence evaluations/audits for new business, partners or CMOs.
- Ensure new/updated Quality Agreements are devleped for Development Partners and CMOs responsible for Combination Products and Medical Devices.
- Provides Quality assessment and advice for interdepartmental peers.
- Responsible for oversight of change management activities for Combination Products and Medical Devices, including implementation strategies and risk management, when necessary.
- Participate and present in communication forums within and between the US, EU and JP Regions including Regional QA and Global QA Meetings, to maintain cohesion and harmonization of common GMP standards and practices. Proactively maintains effective interaction and rapport with key regional and international stakeholders.
- Establishes and maintains a relevant network to maintain up-to-date knowledge of industry standards and practices and to anticipate, proactively respond to trends and/or shifts in external environment to predict impact to QA and/or Astellas businesses.
This position is primarily responsible for directing the oversight of the Quality Assurance requirements for Combination Products and Medical Devices and support of RX+ programs manufactured by Astellas and by Third Party Contract Manufacturing Organizations. Responsible for oversight of Development activities as well as commercial readiness and support.
This position will report directly to the Executive Director of Product Quality Management in support of commercial products. The position will also indirectly report to the VP, Quality Technology in support of development projects. This position could have up to 5 direct reports including contract staff.
- BA / BS required with ten (10) years of industry experience, five (5) years of QA experience and three (3) years managing staff.
- In depth knowledge of cGMP and other regulations as required with a broad knowledge of quality principles and industry trends supporting Combination Products, Medical Devices and Pharmaceuticals, such as 21 CFR Part 4, and other GxP regulations, as applicable.
- Experience in support of development of Combination Products and/or Medical Devices.
- Ability to apply industry knowledge and interpretation to anticipate impact to stakeholders relating to batch record review and product disposition, supplier audit, and risk management.
- Effective written and oral communication, interpersonal skills, facilitation and influencing skills with an ability to effectively work across the Astellas group and external stakeholders.
- cGMP auditing experience required and experience in a medical device and pharmaceutical manufacturing environment desired. Must be able to represent the company to external stakeholders.
- Develops approach for managing one or more areas of responsibility. Executes quality strategy with management guidance. Requires minimal management oversight. Primarily self-directed.
- Previous experience in Medical Device / Pharmaceutical Quality Assurance and previous experience in a GMP pharmaceutical manufacturing plant.
- Previous experience with Software registered as a Medical Device (e.g. Medical Device application)
- Science related degree.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
- Astellas Pharma Jobs