Job Information
Astellas Pharma Manager, Quality Assurance, Technology & Data in Bengaluru, India
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 here!
We are a leading 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.
This position is based in Bengaluru, India. We recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with the Responsible Flexibility Guidelines.
Purpose and Scope:
Responsible for managing and executing the Technology and Data Quality Assurance (TDQA) audit and validation oversight programs related to regional Digital X processes for computer systems, technology solutions, clinical and commercial systems, data integrity processes, and related process improvement initiatives within QA.
Provides operational management to drive consistent cGxP compliance and validation approaches to ensure compliance with standards, policies, and procedures.
Ensures compliance with global Electronic Records / Electronic signatures regulations and related cGxP regulatory requirements.
Responsible for managing the TDQA audit program related to audits of vendors, service providers, and internal processes in support of computerized system validations for new system implementations, system upgrades, change controls, and periodic reviews for computer systems.
Develops, facilitates, and implements process improvements and supports new technology initiatives as continually invests in new technology solutions and computerized systems.
Contributes to the development, implementation, and successful execution of the QA mission, objectives and 3-5 year strategic plan.
Responsibilities and Accountabilities:
Responsible for operationally managing, coordinating, planning, and administering the TDQA program to oversee the computerized systems validation program, and ensuring reviews of computerized system validation documentation is completed to ensure compliance with policies and procedures. Reports status of validation projects to management.
Responsible for operational management, planning, and administration of the TDQA internal and vendor audit program related to computer software providers and computer related service providers utilized. Responsible for scheduling and performing audits. Manages internal and external resources to perform audits. Reports status of audit program to management. Generates trend reports of audit findings for management reviews.
Interacts with functional teams to assist QA management to identify QA activities and resources necessary for review and support of project-related initiatives. Manage programs and resources necessary to support assigned projects.
Identifies, develops, facilitates, and manages process improvement initiatives related to electronic system development life cycles, validation processes, IT systems/processes, data integrity control processes, and regulatory compliance assurance processes throughout. Manages multiple projects concurrently. Collaborates with key stakeholders and functional area customers across the organization for process improvement initiatives.
Serves as QA representative on assigned project teams associated with software validation projects and process improvement initiatives to provide guidance, direction, and support regarding quality assurance and regulatory compliance, to resolve compliance issues, report to management, and to ensure completion of quality related action items.
Ensures and facilitates compliance with global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11). Provides quality and compliance guidance in areas of continuous improvement, innovation, and validation. Collaborates, advises and provides consultation on quality matters to individuals, study/core teams, and functional management teams across the organization.
Assists management for development, coaching, mentoring and support for TDQA resources. Develops staff to serve as QA representatives on assigned project teams to provide direction regarding quality and compliance, to communicate compliance issues to management and to oversee completion of quality related action items.
Manages QA oversight of validation projects related to specific products to assure quality of output as well as compliance with standards, policies, procedures and regulations.
Assists QA management to assess and ensure regulatory inspection readiness. Supports management in presenting and defending validation strategies during regulatory authority and 3rd party inspections.
Develops tools to track and trend compliance metrics, validation activities and issues; and assures that systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation.
Participates in the development of a comprehensive risk management process related to computerized systems validation activities within the company.
Authors, revises, and performs maintenance and administration of departmental quality documents (i.e., policies, SOPs, WPDs/WIs, STLs, etc.) as necessary. Conducts and coordinates validation, compliance, and quality training as needed.
Required Qualifications:
University degree required (Science or IT preferred)
Minimum of 5 years in the pharmaceutical industry, with a minimum of 3 years in a Quality Assurance role.
Demonstrated leadership skills, including the ability to lead and manage projects and staff in a matrixed, global setting.
Demonstrated knowledge of global industry standards and regulatory requirements for, software development, computer system validation, Electronic Records / Electronic Signatures regulations, Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP), and related GxP regulations in the global regulatory environment including GAMP5, 21 CFR Part 11, EU Annex 11, and Japan Notice 0401022.
Demonstrated knowledge of quality assurance of computer system validation process management in a pharmaceutical manufacturing and clinical development environment.
Demonstrated knowledge of development, management, and execution of internal and vendor auditing processes, audit reporting systems, and audit/CAPA management.
Demonstrated experience in facilitating and supporting regulatory agency inspections and third-party audits pertaining to Data Integrity and Electronic Records/Electronic Signatures compliance with successful outcomes.
Demonstrated experience facilitating and leading global process improvement and harmonization activities, especially in the areas of Data Integrity, computing environment development, validation, control, and maintenance.
Demonstrated competence to resolve complex and diverse problems with decision making responsibility that has a major impact within Quality and/or with functional groups globally. Effective written and oral communication and interpersonal skills, facilitation and influencing skills with an ability to interface globally across multiple departments and across various levels of management with external stakeholders.
Domestic and international travel of 5-10% is required.
Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans