Associate Manager Data Integrity Quality Assurance

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 .

Astellas is announcing a Associate Manager, Data Integrity Quality Assuranceopportunity. 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:

Responsible for assisting in the execution of the Data Integrity Quality Assurance (DIQA compliance and oversight program, compliance gap assessments, and participating in related data integrity process improvement initiatives within Astellas. Ensures consistent application of Data Integrity regulations and guidelines to GxP data generated and managed for clinical development and commercial operations across Astellas or Service Providers to ensure compliance with global Astellas standards, policies, and procedures and regulatory requirements. Participates in the oversight of study specific software system builds used for clinical study operations, suchas Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO), and electronic Case Report Forms (eCRF) and performs periodic review of IRT/eCOA User Acceptance Testing (UAT) documents for compliance to procedures. Executes process improvement and supports new technology initiatives for Astellas. Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.

Essential Job Responsibilities:

• Responsible for assisting in the execution of the DIQA compliance oversight program to oversee compliance to Data Integrity regulations and guidelines.

• Executes computerized systems validation oversight pertaining to clinical study operations, including reviewing and approving computerized system validation documentation for compliance with Astellas policies and procedures. Reports status of validation projects to management. Supports DIQAs oversight of computer system validations and User Acceptance Testing of study specific software system builds for systems used for clinical study operations of Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO), andelectronic Case Report Forms (eCRF) including facilitating resolution of any potential compliance risks that arise during a study.

• Executes scheduled periodic reviews of IRT/eCOA UAT documentation for study specific GxP regulated systems to ensure systems are maintained under control and remain in a validated state. Reports required revalidation/remediation activities and ensures activities are completed. ASTELLAS JOB DESCRIPTION This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Employees holding this position may perform other job-related duties in the course of their performance of this position. Rev. 1.16.2012

• Responsible for participating in the execution of the DIQA internal and vendor audit program to assess Astellas internal processes and computer software vendors and computer related service providers utilized by Astellas. Responsible for performing assigned DI compliance assessments, audits, reporting audit findings, and working to ensure appropriate audit response and corrective actions are provided by the business.

• Under the direction of management, works closely with Astellas business function representatives, including Data Sciences, Clinical Sciences, IS, and commercial manufacturing to ensure process control and improvements to ensure Data Integrity compliance andprocess improvement.

• Manages and executes assigned process improvement initiatives related data integrity control processes, and regulatory compliance assurance processes throughout Astellas. Manages multiple assigned projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization for process improvement initiatives and to communicate compliance issues to management.

• Provides QA oversight of assigned projects to assure quality of output as well as compliance with standards, policies, procedures and regulations, including the global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11) and Data Integrity regulations and guidance. Utilizes tools to track and trend compliance metrics, and quality related issues; to ensure that Astellas systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation. Reports project and program status to QA management.

• Participates in the execution of a comprehensive risk management process and risk-based approaches related to data integrity process controls within Astellas.

• Contributes to and manages the administration of departmental controlled documents (i.e., policies, SOPs, WPDs/WIs, Forms, etc.) as necessary. Conducts and coordinates compliance, and quality training as needed.

Quantitative Dimensions:

• Reviews and assesses 50 to 100 IRT/eCOA UAT related documents per year.

• Leads or participates in and reports 5-10 internal and/or data integrity assessments and vendor audits per year.

• Supports the generation of periodic and ad hoc metrics reports of quality and compliance trends of document reviews and conducts an analysis of these metrics on a periodic basis for QA management and the business.

Organizational Context:

• Reports to the Associate Director, Data Integrity Quality Assurance.

• Represents DIQA on IRT/eCOA project teams by offering consultation, advice, and subject matter expertise regarding ERES and DI requirements and when compliance questions arise. Collects guidance from management and relays to project teams as necessary.

• Peers include operational levels in QA clinical development functions and service providers and commercial manufacturing support functions globally. ASTELLAS JOB DESCRIPTION This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Employees holding this position may perform other job-related duties in the course of their performance of this position. Rev. 1.16.2012

• At the direction of management, provides consultation on quality and compliance matters to individuals, study/core teams, project teams, and functional area teams across the Astellas organization. Collaborates directly with QA operational members, QA staff, and various levels within Astellas functions including other functions outside of M&D that require support from DIQA.

• Functions as the QA main point of contact for assigned teams and functional areas requiring support from DIQA locally and globally

Qualifications:

Required: .

• Bachelor of Arts/ Bachelor of Science degree

• Minimum 2 years of experience in the pharmaceutical industry

• Minimum of 2 years of experience in quality assurance in the pharmaceutical industry

• Minimum 2 years of experience performing or overseeing Data Integrity compliance, software/system development life cycle and computer system validation.

• Minimum 2 years supporting study specific computer system implementations.

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

• Proficiency in Microsoft Office and SharePoint collaboration sites (or similar)

Skills and Competencies:

• Basic knowledge of GxP regulations and computerized systems in GXP regulated environments, preferably for pharmaceuticals, relating to product development, combined with broad knowledge of quality principals and industry trends.

• Basic knowledge of global industry standards and regulatory requirements for software development, computer system validation, data integrity and Electronic Records and Electronic Signatures regulations. Experience in these disciplines in the pharmaceutical industry.

• Familiarity with GxP regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.

• Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams. Collaborative skills to facilitate, manage, and work within project teams across departments and global organizations. 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.

• Ability to proactively predict and resolve complex problems, think strategically and tactically, ASTELLAS JOB DESCRIPTION This job description is intended to describe the general nature and level of work which may be performed by the person assigned to this position. This job description is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of this position. Employees holding this position may perform other job-related duties in the course of their performance of this position. Rev. 1.16.2012 execute solutions to complex problems. Able to generate insights and leverage learnings at the individual, team and functional level.

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

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

Preferred:

• Advanced Degree

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

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