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Astellas Pharma Associate Device Software Quality Assurance Director in Northbrook, Illinois

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Responsible for managing the QA strategy and oversight for product development and commercialization for medical devices utilizing software components as/or in medical devices. Provides QA subject matter expertise, guidance, and compliance oversight for Astellas device product development projects incorporating Software as a Medical Device and Software in a Medical Device. Collaborates with product development teams and QA colleagues to provide guidance regarding regulatory compliance and quality aspects of products in development, commercialization, and approved marketed devices. Responsible for the management and maintenance of the Quality Management System supporting software components of device products and documentation supporting related regulatory submissions. Identifies and drives process and compliance improvement initiatives. Provides strategic leadership in driving a consistent cGxP compliance and validation approaches for Astellas global policies, procedures, and standards pertaining to software as a medical device and software in medical devices. Performs 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 compliance oversight based on risk. Develops staff to serve as QA representatives on assigned project teams.

Essential Job Responsibilities:

  • Responsible for directing and executing the QA program to oversee compliance of the activities and documentation pertaining to product development and commercialization of medical device products utilizing Software as a Medical Device (SaaMD) or Software in a Medical Device (SiaMD). Oversees the compliance of product development, software development / validation, and design history file documentation for medical device products using software.

  • Provides Quality Assurance subject matter expertise, guidance, and compliance oversight support for Software as a Medical Device product development projects as necessary to build required Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).

  • Develops and drives the implementation of quality strategies and tactics related to compliance of technology solutions 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 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 software development and product development processes, technology solutions, and validation projects pertaining to SaaMD and SiaMD to assure quality of output as well as compliance with standards, policies, procedures and regulations. Presents and defends compliance during Regulatory Authority Inspections and 3rd Party Audits. Utilizes risk-based approaches to process oversight.

  • Directs the establishment and execution of internal and vendor audit program related to software developers and product development partners utilized by Astellas for device product development and commercialization. Manages internal and external interactions related to due diligence and integration projects, and other 3rd party interactions related to the assurance of Astellas 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 QA group. Anticipates and plans for resource needs to utilize in-house and out-sourced personnel. Works with senior management to prioritize department 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 QA management team to provide management with guidance and input related to SaaMD and SiaMD compliance 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 QA oversight and Quality Management System compliance and maintenance across multiple departments and levels of management. Responsible for facilitating and collaborating with cross functional areas for process improvements and 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 SaaMD and SiaMD to ensure regulatory compliance of Astellas processes and outputs. Ensures inspection readiness for regulatory inspections, 3rd Party audits and internal audits. Provides leadership to functional areas with minimal management oversight. Provides guidance to functional areas across Astellas for ERES, medical device regulations, and quality systems related consultations. Represents QA management on process improvement project teams to provide regulatory compliance 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 Astellas systems and procedures comply with Astellas and external regulatory authority requirements for compliance. Collects and shares metrics to facilitate the Management Review process.

Quantitative Dimensions:

  • Oversees compliance with approximately 75 Quality Management System documents (policies, standards, SOPs, WPDs/WIs, and STLs) pertaining to SaaMD and SiaMD product compliance.

  • Manages the global regulatory compliance oversight for all Astellas SaaMD and SiaMD products within the M&D and Commercial organizations.

  • Manages the QA review and approval of Design History File documentation for approximately 3-5 product development projects per year.

  • Manages the audit and assessment of approximately 3-5 computer system/software development service providers per year.

Organizational Context:

  • Reports directly to the Sr. Director, DIQA of Quality Assurance.

  • May have supervisory responsibility for contract/consultant resources and/or 1-5 direct reports at Associate to Sr. Manager level.

  • Works directly with management in all Astellas functions, Quality Assurance, and Information Systems.

Qualifications:

Required

  • Minimum BA / BS or equivalent (science-related preferred) with 8+ years of industry experience, 6+ years of QA experience with 3-5 years of experience managing staff preferred. Advanced degree preferred.

  • Comprehensive knowledge of medical device regulations and requirements pertaining to Software as a Medical Device, Software in a Medical Device, Design History File, and industry standards ISO13485, 62304, 82304. Knowledge of medical device development, Design History File creation and maintenance, and device commercialization processes in regional and global GxP regulated environments, 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.

  • 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 medical device product development, submission, and/or commercialization.

  • Demonstrated ability to establish Quality policies, Quality Management Systems, 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 compliance and QA 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 Astellas.

  • 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.

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 401(k) match and annual company contribution

  • Company paid life insurance

  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

  • Long Term Incentive Plan for eligible positions

  • Referral bonus program

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Category Quality Assurance/Quality Control

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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