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 Manager, Data Integrity Quality Assurance opportunity. 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 executing 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, procedures and regulatory requirements.

Responsible for oversight of study specific software system builds used for clinical study

operations, such as Interactive Response Technology (IRT), electronic Patient Reported

Outcomes (ePRO), and electronic Case Report Forms (eCRF). Drives compliance

improvements by developing, facilitating, and implementing process improvements and

supports new technology initiatives for Astellas. Contributes to the implementation, and

successful execution of the QA mission, objectives and 3-5 year strategic plan

Essential Job Responsibilities:

• Responsible for executing the DIQA compliance oversight program to oversee compliance to

• Data Integrity regulations and guidelines.

• Executes oversight of the computerized systems validation program 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

• Oversees and supports 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), and electronic

• 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 in order to ensure systems are maintained under control and remain in a

• validated state. Identifies required revalidation/remediation activities and ensures activities are

• Responsible for executing 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 scheduling and performing DI compliance

• assessments, audits, reporting audit findings, and working to ensure appropriate audit

• response and corrective actions are provided by the business.

• Work closely with Astellas business functions, including Data Sciences, Clinical Sciences, ISS,

• and commercial manufacturing to ensure process control and improvements to ensure Data

• Integrity compliance and process improvement.

• Facilitates and manages 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

• Develops and 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 development of a comprehensive risk management process and risk based

• approaches related to data integrity process controls within Astellas.

• Authors, revises, and performs maintenance and administration of departmental controlled

• documents (i.e., policies, SOPs, WPDs, Forms, etc.) as necessary. Conducts and coordinates

• compliance, and quality training as needed.

Compliance:

• Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively

• applied in all initiatives. Ensure Quality Assurance Function(s) strictly adopt a culture of ethics and compliance; leading by

• example and appropriately challenging non-compliance. Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions

• with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs) and Patient Organizations (POs).

Mandatory Compliance requirements:

• To be aware of Astellas' Group Code of Conduct and associated policies and procedures and other

• applicable laws, codes and regulations.

• Clarify and seek guidance as required, and raise any concerns, in a timely manner, with relevant

• manager, which may include reference to the Ethics and Compliance Team and/or Ethics and

• Compliance Helpdesk.

• Undertake and comply with relevant mandatory Ethics and Compliance training and updates to

• maintain personal awareness; all training to be undertaken in a timely manner.

• Be aware of and comply with, the Astellas Way and Astellas Competencies, in terms of expected

• values and behaviors, in addition to Astellas' HR policies, procedures and guidelines.

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 Data Integrity and IRT/eCOA project teams by offering consultation,

• advice, and subject matter expertise regarding ERES and DI requirements and when

• compliance questions arise.

• Peers include operational and management levels in QA clinical development functions

• and service providers and commercial manufacturing support functions globally.

• Collaborates, advises and provides consultation on quality and compliance matters to

• individuals, study/core teams, project teams, and functional area teams across the Astellas

• Collaborates directly with QA operational members, QA staff, and various levels across

• Astellas functions.

• Functions as the QA main point of contact for assigned teams and functional areas.

Qualifications:

Required:

• Bachelor of Arts/ Bachelor of Science degree

• Minimum 4 years of experience in the pharmaceutical industry

• Minimum of 4 years of experience in quality assurance in the pharmaceutical industry

• Minimum 4 years of experience performing or overseeing Data Integrity

• compliance, software/system development life cycle and computer system

• Minimum 2 to 4 years supporting study specific computer system implementations.

• 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 and SharePoint collaboration sites (or similar

Skills and Competencies:

• In-depth 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.

• In-depth knowledge of global industry standards and regulatory requirements for Data Integrity,

• software development, computer system validation, and Electronic Records and Electronic

• Signatures regulations. Experience in these disciplines in the pharmaceutical industry.

• 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. Collaborativeskills 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

• 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

• Able to generate insights and leverage learnings at the individual, team and

• functional level.

• Strong planning and organizational skills and experience managing multiple priorities

• 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 QA

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