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Astellas Pharma Director, Clinical Quality Assurance (Process & Continuous Improvement Lead) 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.

Purpose & Scope:

Responsible for the development and maintenance of excellence in Clinical QA (CQA) activities for Astellas sponsored programs. This position works in partnership with Medical and Development (M&D) and other business units in support of global and local drug development, registration and marketing for assigned projects across Therapeutic Areas (TAs) and for all stages of drug development.

Reports to the Executive Director/Senior Director/Director, CQA and contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 years strategic plan.

Under the guidance of the Executive Director/Senior Director/Director, CQA, the role will lead CQA projects and/or non-project activities to ensure that M&D processes and clinical trials (Phase I-IV) are executed in compliance with the international regulatory requirements for Good Clinical Practice (GCP) and other relevant (inter)national regulations. Mentor within CRQA leading the way for others to follow and demonstrate CRQA's ability to foster a collaborative environment to accomplish common goals within CRQA and across other functional areas.

Essential Job Responsibilities:

  1. Develops strategy and executes the direction for CQA's approach under the guidance of the Executive Director/Senior Director/Director, CQA. In collaboration with the CQA Management Team and stakeholders regionally and globally, implements the development of this approach to ensure an effective quality program which complies with regulatory requirements and stakeholder expectations. Provides the leadership to drive the development, communication, implementation, maintenance and execution of standards and processes within the function and communicates to relevant stakeholders.

  2. Manages, directs and/or provides leadership to CQA staff. Responsible for the development, mentoring and support of direct reports and/or appropriate CQA resources. Could be responsible and accountable for the CQA staff recruitment, development and performance management and organizing CQA teams for maximum effectiveness

  3. Continuously evaluates the strategic approach, drives changes in the quality and audit program to meet changing needs of the organization, regulatory environment and industry best practices. Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)

  4. Creates and implements the appropriate strategic risk-based support model for assigned project. Represents CQA as a Global Quality Lead (GQL) for M&D clinical projects across TAs. Represents CQA on Core and Project teams.

  5. Development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate

  6. Collaborates within CRQA and M&D functions to establish the global audit and oversight program

  7. Responsible for managing the assigned budget for the CQA group as part of the overall CRQA budget.

  8. Manages and grows the direct reports and CQA resources as appropriate through effective recruitment, performance. management, development planning and retention. Delegates responsibilities and empowers team members to achieve goals. Provides optimal oversight and supervision while developing individuals and leveraging their skills and abilities to ensure goals are achieved

  9. Drives consistency across projects, processes and organization by (not limited to):

  10. leading process improvement and operational excellence activities across CRQA and M&D functions.

  11. supporting and executing Due Diligence and/or post acquisition activities.

  12. supporting inspection readiness activities

  13. Enhancing stakeholder relationship to ensure compliance and consistency of regulate activities and associated processes

  14. Triage of new regulatory requirements, guidances and/or regulations related to GCP and lead the impact analysis to determine if changes in process & quality documents across CRQA and M&D functions are required.

  15. driving trending and metrics across studies and M&D business processes.

  16. Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CRQA key stakeholders and M&D functions, as well as of relevant external stakeholders

Quantitative Dimensions:

  • Supports/manages up to 3 CQA resources and/or directly manages 1-5 process improvement/operational excellence initiatives

  • Responsible for a budget up to $500K

  • Annual auditing globally

  • Functional Service Provider (FSP)/Vendor governance support for up to 3 FSP relationships

  • Responsible for the development and execution of inspection readiness plans of approximately 1-2/annum for regulatory agency inspections related to MAA / NDA submissions

  • Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 4 inspections/annum

Organizational Context:

This position:

  • Reports to the Executive Director/Senior Director/Director, CQA

  • Peers to this position include CRQA Team Leads, global and regional M&D Team Leads and other functions such as Finance, Legal, Internal Audits, Ethics & Compliance, etc.

  • Supports/Manages up to 3 direct reports and/or outsourced support staff excluding administrative assistants

  • Collaborates directly with M&D personnel

Qualifications:

Required:

  • Bachelor's degree

  • Minimum of 6 years working within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development or Operations

  • Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations and procedures

  • Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations

  • Minimum of 2 years of significant experience in clinical quality assurance

  • Minimum of 2 years people/project management experience, preferably in a highly matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills

  • In-depth understanding of GCP requirements for both marketed and investigational products

  • Extensive practical experience and understanding of clinical quality assurance as applied throughout the entire pharmaceutical compound/product life cycle

  • Proficiency in Microsoft Office.

Skills & Competencies

  • Effective 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. Demonstrated competence to build strong working relationships with colleagues and stakeholders

  • Effective oral and written communication and presentation skills in English.

  • 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

  • Domestic and international travel at 10-25% as required.

Preferred

  • Advanced degree in related disciplines

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

#LI-SS

Category Clinical and Research Quality Assurance (CRQA)

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

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