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Astellas Pharma Associate Device Quality 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:

The Associate Device Quality Director, reports to the Senior Director, Device Quality and contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5-year strategic plan.

This role is responsible for supporting the Quality Management System (QMS) to support the Product Lifecycle management for Astellas Medical Devices and Combination Products. This role ensures the Astellas QMS medical device elements are maintained globally, which includes central oversight over medical device QMS training, effectiveness checks and internal audits. Partners with stakeholders to ensure changes and continuous improvements to the quality management system are planned and implemented in accordance with ISO13485, EU MDR 2017/745 and FDA Part 4 requirements.

Essential Job Responsibilities:

  • Responsible for implementing new or revised medical device and combination product QMS requirements. Serves in a leadership role as part of QA. Accountable for integrating process development, improvement and strategy with QA leadership for the medical device and combination product QMS.

  • Responsible for the analysis and implementation of global medical device and combination product regulations training curriculum which demonstrates compliance with mandatory regulatory requirements.

  • Responsible for selecting and partnering with vendors to design and develop medical device and combination product QMS training.

  • Responsible for publishing annual internal audit schedule of the Medical Device and Combination Product QMS elements. Ensure qualified Astellas auditors and/or external contractors are identified to conduct the audits.

  • Responsible for vendor contract negotiations with outsourcing partners and ensures compliance with contract terms and conditions in collaboration with Procurement.

  • Provides leadership to achieve quality goals, develops and implements an ongoing education program for QMS processes while developing measures to monitor the effectiveness of the QMS itself and drive remediation for improvement.

  • Responsible for leadership, development and management of an effective and compliant QMS by working closely with all levels of personnel and management across Astellas functions. Provides quality solutions by participating in business activities and initiatives to promote the awareness of quality.

  • Participates in effective communication forums and presents Quality System Device Quality strategy to Astellas Functions/Divisions. Establishes and promotes positive, timely, and collaborative interactions with all Astellas entities to support the effective and efficient application of the Astellas QMS.

  • Applies knowledge of the Code of Federal Regulations, ICH Guidelines, ISO standards and other applicable regulations, policies, and procedures for oversight and management of QMS requirements. Interprets new and revised medical device global regulatory requirements to identify, drive, support and/or manage process improvement initiatives to ensure Astellas maintains compliance with medical device regulatory requirements.

  • Establishes membership in appropriate professional bodies, contacts with peers from respected ethical companies as well as attends relevant meetings and symposia to maintain up-to-date knowledge of industry standards and practices.

Quantitative Dimensions:

  • Responsible for contribution to obtain the quality inputs and outputs of Management Review and deliverables for QA related to Medical Devices and Combination Products. Analyze metrics on an on-going basis (i.e. monthly) in preparation for Management Review. Provides guidance in driving consistency across the organization.

  • Functions as the QA main point of contact for all functional areas utilizing the medical device and combination products Quality Management System locally and globally.

  • QA oversight for global QMS activities to support the development, launch and maintenance of Astellas Products including advanced therapy medicinal products, Medical Devices and Combination Products.

Organizational Context:

The position reports to the Senior Director, Device Quality. This person will be responsible for the QA operation of QMS activities for Medical Devices and Combination Products. Works directly with Astellas senior management. The Associate Director, Device Quality is responsible for providing support and guidance to Astellas personnel supporting medical device.

Collaborations

Responsible for the maintenance of effective collaborations with internal QA key stakeholders and functions including:

  • Medical Affairs

  • Development

  • Pharmaceutical Technology

  • Pharmacovigilance

  • Regulatory Affairs

  • Commercial

  • RxCollaborates closely with functional senior management to influence and ensure alignment with the Quality Systems deliverables to drive a consistent quality culture and direction in all regulated areas. Cultivates cross-functional relationships to ensure a culture of continuous quality improvement, compliance and successful execution

Qualifications:

Required

  • Minimum of a Bachelor of Arts/ Bachelor of Science degree. Advanced degree preferred.

  • Minimum of 7 years quality assurance experience in the medical device industry

  • Working knowledge of ISO 13485, EU MDR 2017/745 and FDA Part 4

  • Minimum of 4 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.

  • Proficiency in Microsoft Office

  • Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.

  • Excellent oral and written communication as well as presentation skills.

  • Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.

  • Strong planning and organizational skills and experience managing multiple priorities simultaneously.

  • Strong leadership skills; communicates and demonstrates vision and commitment.

  • Domestic and international travel of 10-15% is required.

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

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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