Astellas Pharma Associate Director, Technology & Data Quality Assurance 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, Technology & Data Quality Assurance opportunity in Northbrook, IL.
Position & Scope:
Responsible for managing the Technology & Data Quality Assurance department to provide strategy for the oversight and quality services for Astellas processes for computer system validation program, clinical and commercial electronic systems, data integrity processes, and related continuous process improvement initiatives. Provides strategic leadership in driving a consistent cGxP compliance and validation approach Astellas global policies, procedures, and standards. Performs Electronic Records / Electronic Signatures regulation and related cGxP regulation surveillance to provide guidance and instruction to the Astellas organization to ensure compliance with regulatory requirements. Anticipates and develops QA activities and processes related to electronic systems oversight based on risk. Develops staff to serve as QA representatives 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.
Essential Job Responsibilities
- Directs TDQA program to oversee the computerized systems validation program, clinical, commercial, and R&D electronic systems, and data integrity processes. Performs and ensures issue resolution, audits, and regulatory authority inspection preparation. Facilitates and leads the development and implementation of related continuous process improvement programs within Information Technology and business departments.
- Develops and drives the implementation of quality strategies and tactics related to Electronic Systems and overall Quality discipline that ensure long term success for the quality assurance function. Translates strategies into prioritized short- and long-term objectives for the TDQA and QA department. Leads initiatives and programs across multiple departments, regions, business functions, and internal/external partners. Establishes and prioritizes quality initiatives to ensure execution of multiple projects concurrently.
- Responsible for the overall management of QA oversight of IT processes, electronic systems, and validation projects to assure quality of output as well as compliance with standards, policies, procedures and regulations. Presents and defends validation strategy during Regulatory Authority and 3rd Party Inspections. Utilizes risk-based approaches to process oversight.
- Directs the establishment and execution of internal and vendor audit program related to computer software providers and computer related service providers utilized by Astellas. Manages internal and external interactions related to due diligence and integration projects, and other 3rd party interactions related to the assurance of Astellas ERES compliance and data integrity processes.
- Supervisory responsibility for providing leadership, development, coaching, mentoring and support for direct reports. Responsible and accountable for hiring and performance management of direct reports within the TDQA group. Anticipates and plans for resource needs to utilize in-house and out-sourced personnel. Works with senior management to prioritize dept work and resource allocation / acquisition.
- Develops staff to serve as QA representatives 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. Represents QA on regional and global teams, activities and projects.
- Member of the CRQA management team to provide management with guidance and input related to electronic systems and data integrity topics to contribute to the overall QA and QMS strategies. Represents QA in interactions with regulatory agencies during inspections, 3rd Party audits, and customer interactions.
- Develops and drives the implementation of policies, procedures, standards, and tools in support of validation processes, data integrity processes, and quality systems and interfaces across multiple departments and levels of management. Responsible for facilitating and collaborating with cross functional areas to resolve complex and diverse problems with decision making responsibility for issues with major impact to stakeholder relationships, dossier approvals, compliance status, and Astellas credibility and/or revenue). Authors, reviews, and approves departmental Quality System Documents as necessary. Participates in the biennial review of Quality System documentation.
- Interprets regulatory requirements for electronic and data integrity systems to identify, support and/or manage local and global process improvement initiatives to ensure compliance with GxP regulatory requirements and Electronic Records/Electronic Signatures regulations. Ensures inspection readiness for regulatory inspections, 3rd Party inspections and internal audits. Provides leadership to functional areas with minimal management oversight. Provides guidance to functional areas across Astellas for ERES, validation, and quality systems related consultations. Represents QA management on process improvement project teams to provide regulatory and technical expertise in all areas of continuous improvement, innovation, and validation.
- Manages the development and utilization of tools to track, trend and report quality metrics to management to assure that APGD systems and procedures comply with Astellas and external regulatory authority requirements for compliance. Collects and shares metrics to facilitate the Management Review process.
- Ensures close and effective collaboration with functional colleagues across Astellas for process improvement and execution of audit scheduling, audit conduct, validation process, and validation oversight.
- Minimum BA / BS or equivalent (science-related preferred) with 10+ years of industry experience, 6 years of QA experience with 3-5 years of experience managing staff preferred.
- Comprehensive knowledge of computerized systems in regional and global GXP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends.
- Comprehensive knowledge of global industry standards and regulatory requirements for software development, computer system validation, and Electronic Records and Electronic Signatures regulations in the global regulatory environment including GAMP5, 21 CFR Part 11, EU Annex 11, and Japan Notice 0401022 and Data Integrity requirements. Experience in these disciplines in the pharmaceutical industry.
- Electronic Systems QA / validation process management experience required and experience in a pharmaceutical manufacturing or clinical development environment preferred. Comprehensive knowledge of GMP, GCP, and GLP regulations and understanding of global quality standards relating to product development, submission and/or commercialization. Demonstrated ability to establish local and regional Quality policies and to contribute to global Quality policies in support of the quality system.
- Demonstrated knowledge of development, management, and execution of internal and vendor auditing processes, audit reporting systems, and audit CAPA management.
- Demonstrated experience identifying, facilitating, assisting, and leading regional, bi-regional, and global process improvement and harmonization initiatives. Ability to assist or lead strategic development and/or successful execution of plans and initiatives that ensure long term success for ERES compliance and QA at a regional or global level with minimal management oversight.
- Demonstrated accountability to resolve complex and diverse problems with decision making responsibility that has a significant impact (e.g., stakeholder relationships, dossier approvals, compliance status, credibility and/or revenue) within QA and across the APGD.
- Demonstrated ability to anticipate, proactively respond to trends, and/or shifts in the external environment (e.g., regulatory, business partner relationships, industry standards) and to predict impact on quality assurance and/or Astellas business units.
- Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to interface regionally across multiple departments, and among various levels of management within Astellas group and external stakeholders. Demonstrated ability to solicit input and liaise with stakeholders to prioritize and set strategic direction for change. Assist in the identification and implementation of short and long-term business planning strategies, assuring quality is taken into consideration.
- Demonstrated ability to develop quality assurance professionals and to both lead and manage a functional quality assurance unit.
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