Associate Director – Global CSQA

3 weeks ago

Bengaluru, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Position Description:

The Senior Manager – Global CSQA (LCCI) is responsible for daily operations within their assigned team of CSQA Reps at LCCI. This role supports the LCCI account and CSQA team locally at LCCI. As such they will support projects and activities across multiple IT functions collaborating with the more functionally aligned CSQA Associate Directors. This role includes strong capacity and personnel management, staff development, project and business planning/management, and cross-functional communication. The Senior Manager collaborates closely with other members of the Global Information Systems Quality (GISQ) Lead Team to provide strategic input and ensure alignment with GISQ objectives. Additionally, they ensure that supported computer systems comply with corporate computer system validation standards and practices.

Key Objectives/Deliverables:

Personnel Management

Recruit for and staff positions to meet business needs while leveraging diverse global talent. Supervise direct reports and facilitate performance management, personnel development, and career development through coaching and transparent feedback; escalate issues to upper management as appropriate. Create a culture of accountability, excellence, integrity, and inclusion. Appropriately identify and resolve personnel issues in collaboration with human resources and functional management. Participate and represent staff in succession planning activities, talent assessment, annual compensation review, promotion processes, and reward and recognition activities to retain and motivate staff. Ensure development, implementation, and compliance of training for team personnel. Partner with LCCI Human Resources
 

Maintain Inspection Readiness

Ensure systems within the assigned portfolio of quality oversight are kept continually inspection ready. Manage resources to effectively provide oversight of supported areas and ensure quality issues are properly documented and tracked with appropriate Quality/CAPA plans and are escalated appropriately. Understand outputs from self-inspections, audits, and vendor evaluation activity and their impact on compliance health and priorities. Provide periodic updates to key functional management and stakeholders as appropriate.

Streamline and Continuously Improve

Drive strategy and direction as key member of GISQ Leadership team. Oversee and/or sponsor streamlining and simplification initiatives both within GISQ team as well as those that impact business partner areas. Improve internal processes and influence process improvements.

Deliver Projects, Programs, and Support

Ensure delivery of CSQA services to business partner areas. Understand business partner, company, and Quality priorities. Connect business partners with answers on matters related to Corporate Computer Systems standards and practices. Approve key deliverables to ensure compliance. Establish and nurture account management relationships with partners to ensure alignment on priorities, quality concerns, risks, and operational needs. Ensure CSQA team members provide risk-based guidance, hold the line on compliance, and maintain oversight of compliance through separation of duties with

Minimum Requirements:

University degree in a technology-related field such as Computer Science, Engineering, Mathematics, or Life Sciences; or equivalent experience (i.e., 3+ years’ experience in Automation/IT or computer system validation) Minimum 3 years’ experience directly leading people. Demonstrated strong oral and written communication and interpersonal interaction skills. Solid understanding of IT systems development life cycle Experience with computer systems validation, including application of external GxP regulatory expectations.

Additional Preferences:

Previous experience with Computer Systems Validation, including support of systems and/or programs. Previous experience in GMP, GLP, GCP environment. Understanding of process development and/or improvement (e.g. Six Sigma). Technical knowledge of IT system development lifecycle. Knowledge of Lilly business as it relates to impact to products and patients. Familiarity with IT Best Practices (e.g., LSEF, ITIL).

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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