Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science.
This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Manager, Data Integrity Quality Assurance opportunity in Northbrook, IL. Purpose & Scope :
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 M&D.
Ensures consistent application of Data Integrity regulations and guidelines to GxP data generated and managed for clinical development by M&D or Service Providers to ensure compliance with global Astellas standards, policies, and procedures and regulatory requirements.
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).
Performs periodic review of IRT / eCOA User Acceptance Testing (UAT) documents for compliance to procedures.
Develops, facilitates, and implements process improvements and supports new technology initiatives for Astellas.
Contributes to the development, implementation, and successful execution of the CRQA 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 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 management.
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. To order to ensure systems are maintained under control and remain in a validated state.
Identifies required revalidation / remediation activities and ensures activities are completed.
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 M&D.
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 M&D business functions, Data Sciences, Clinical Sciences, QPOS, and ISS 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 M&D.
Manages multiple assigned projects concurrently. Collaborates with key stakeholders and functional area customers across the Astellas organization (local and global) 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 guidances.
Develops and utilizes tools to track and trend compliance metrics, and quality related issues; to ensure that M&D 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 activities data integrity process controls within M&D.
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. Quantitative Dimensions :
Reviews and assesses 50 to 100IRT / 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.
Peers include operational and management levels in CRQAclinical development functions within M&D and clinical service providers 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 organization.
Collaborates directly with CRQA operational members, CRQA staff, and various levels within M&D functions including other functions outside of M&D that require support from DIQA.
Functions as the CRQA main point of contact for assigned teams and functional areas requiring support from DIQA locally and globally. Qualifications : Required :
Minimum of a Bachelor of Arts / Bachelor of Science degree
Minimum 4 years experience in the pharmaceutical industry
Minimum of 4 years experience in quality assurance in the pharmaceutical industry
Minimum 4 years experience performing or overseeing Data Integrity compliance, software / system development life cycle and computer system validation.
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 software development, computer system validation, data integrity 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.
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.
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.
Domestic and international travel of 10-15% is required. Preferred
Preferred location for this position is Northbrook (IL), United States.
Proficiency in Microsoft Access and SharePoint collaboration sites (or similar). #LI-VB Equal Opportunity Employer Minorities / Women / Protected Veterans / Disabled