zimmer biomet
Website:
zimmerbiomet.com
Job details:
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
The Software Validation Manager is responsible for leading and continuously evolving the Computer Software Validation (CSV) and Computer Software Assurance (CSA) program supporting GxP computerized systems across global business functions. This role provides strategic leadership, governance, and oversight for validation activities throughout the computerized system lifecycle while ensuring compliance with global regulatory requirements, industry standards, and company quality standards.
The Software Validation Manager leads and develops the validation team while partnering with Business, Information Technology, Quality, Regulatory Affairs, Engineering, Cybersecurity, and external vendors to establish validation strategies, oversee execution of validation programs and projects, implement risk-based Computer Software Validation/ Assurance practices, and drive continuous improvement and operational excellence across the validation organization.
This e role supports regulatory inspections and audits and provides oversight of supplier validation resources and deliverables throughout project executions. It also supports the adoption of modern technologies including Cloud, SaaS, AI-enabled applications, enterprise system integrations, and data migration/transformation initiatives while maintaining inspection readiness and ensuring patient safety, product quality, and data integrity.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
Shift Timing - 8:00 AM - 5:00 PM
How You'll Create Impact
- Lead and Oversee day to day CSV/CSA activities and support daily Computer Software Validation (CSV) and Computer Software Assurance (CSA) function activities for supporting global GxP computerized systems, ensuring compliance with applicable regulatory quality, and business requirements.
- Ensure the effective implementation and ongoing maintenance of the organization's CSV/CSA governance framework, overseeing adherence to policies, procedures, standards, templates, and validation methodologies and driving updates where required.
- Establish validation strategies and methodologies based on system risk, complexity, and intended use, and regulatory expectations.
- Ensure validation activities comply with internal procedures and applicable global regulations.
- Provide Validation leadership throughout the computerized system lifecycle including implementation, enhancement, upgrade, migration, retirement, and periodic review.
- Provide Validation leadership for Cloud based Applications, Saas Platforms, ERP, QMS, PLM, Manufacturing Systems, AI-enabled applications, and enterprise integrations.
- Provide Validation Oversight for Data Migration/Transformation Projects ensuring data mapping, migration accuracy, reconciliation, traceability and integrity are verified through appropriate validation activities.
- Review and Approve validation deliverables such as VDRA, Validation Plan, Data Migration Plan, Validation Reports as required.
- Provide validation oversight for data migration projects, ensuring data mapping, migration accuracy, reconciliation, traceability, and data integrity are verified through validation activities defined in the Data Migration Plan and documented in the Data Migration Report.
- Drive consistent validation practices across business functions and global regions.
- Promote risk-based Computer Software Assurance principles across the organization and facilitate risk assessment determinations for appropriate validation scope, testing strategies, and assurance activities.
- Apply critical thinking to determine appropriate assurance activities.
- Standardize CSA practices across validation projects.
- Support validation and governance activities such as developing testing strategies, performing risk assessments for AI-enabled solutions
- Drive process improvements across validation methodologies.
- Develop standardized templates, procedures, and best practices.
- Establish and monitor validation program metrics and key performance indicators (KPIs) to drive continuous improvement.
- Support organizational initiatives that improve quality, compliance, and delivery.
- Support resource planning, onboarding, knowledge development, and competency building within the validation team.
- Manage and Mentor Validation consultants and internal employees.
- Build strong relationships with internal and external stakeholders.
Project And Program Management
- Lead multiple concurrent validation projects supporting enterprise initiatives.
- Develop validation plans, project schedules, resource estimates, and execution strategies.
- Monitor project health, milestones, risks, dependencies, and deliverables.
- Provide ALM execution metrics, reporting and dashboards to the Leadership
- Escalate project risks and recommend mitigation strategies to leadership.
- Ensure validation deliverables are completed on schedule, within scope, and meet quality expectations.
- Ensure validated systems remain in a state of compliance through effective change control procedures observance, periodic review, and lifecycle management practices.
- Oversee supplier and consultant validation activities to ensure compliance with company standards and project requirements.
What Makes You Stand Out
Technical Expertise
- Expert knowledge of Computer Software Validation (CSV), Computer Software Assurance (CSA), and software quality assurance principles within GxP regulated environments.
- Comprehensive understanding of the Software Development Life Cycle (SDLC), including Agile, Waterfall, and hybrid development methodologies.
- Demonstrated expertise in the validation of computerized systems throughout their lifecycle, including implementation, configuration, enhancement, integration, migration, and retirement.
- Strong knowledge of risk-based validation methodologies, change management, deviation management, CAPA processes, and computerized system governance.
- Thorough understanding of applicable regulatory requirements and industry standards, including FDA 21 CFR Part 11, FDA QMSR (21 CFR Part 820), EU Annex 11, GAMP® 5 (Second Edition), ISO 13485, and ALCOA+ Data Integrity principles.
- Experience validating cloud-based, Software-as-a-Service (SaaS), On-premises, and hybrid enterprise applications.
- Knowledge of electronic records and electronic signatures (ERES), audit trail reviews, cybersecurity considerations, and data integrity controls.
- Experience validating enterprise system integrations, APIs, middleware, automated interfaces, ETL processes, and data migration/transformation activities.
- Understanding of emerging technologies, including AI-enabled software solutions, automation platforms, and associated Computer Software Assurance considerations.
- Experience supporting supplier qualification, vendor oversight, regulatory inspections, internal audits, and compliance remediation activities.
- Experience developing validation strategies, governance frameworks.
- Experience supporting the development of procedures and standards for GxP computerized systems.
- Experience in using Application Lifecycle Management (ALM) tools to manage and maintain requirements, test scripts, test executions, and defects throughout the software development lifecycle.
- Experience in Developing and generating ALM reports to provide visibility into requirements coverage, test execution status, defect trends, and project progress.
Additional Qualifications
- Experience in Windchill, ETQ, Camstar, S4 HANA, Robar applications is a plus
Leadership Competencies
- Proven leadership in managing cross-functional teams and complex validation programs within a global organization.
- Strong strategic planning, organizational, and execution capabilities.
- Excellent stakeholder management skills with the ability to build collaborative relationships across Business, Information Technology, Quality, Regulatory Affairs, and external partners.
- Exceptional written, verbal, and executive communication skills, including the ability to present technical concepts to diverse audiences.
- Demonstrated ability to influence decisions, manage competing priorities, and drive results within a matrix organization.
- Strong analytical thinking, sound judgment, and effective decision-making capabilities.
- Commitment to continuous improvement, operational excellence, and organizational development through coaching, mentoring, and talent development
- Demonstrated ability to lead regulatory inspections, audit readiness activities, and compliance remediation efforts.
Your Background
- Bachelor’s degree in computer science, Information Technology, Engineering, Life Sciences, or related field required
- Minimum of 10 years of experience in Computer Software Validation or regulated Technology
- Minimum of 5 years’ experience leading validation projects and cross functional teams.
- Demonstrated experience supporting GxP regulated computerized systems.
- Strong understanding of Software Development Lifecycle (SDLC) and Computer Software Assurance (CSA).
- Experience leading validation activities for enterprise software implementations, upgrades, migrations, and integrations.
- Preferred:
- Project Management Professional (PMP) certification.
- ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
- GAMP® training.
- Experience working with offshore or outsourced vendors.
- Experience working in a regulated/validation environment.
- FDA 21 CFR 820 or ISO 13485 working knowledge.
- Experience with AI-enabled systems and digital transformation initiatives.
- Experience managing global validation teams.
- People leadership experience, including coaching, mentoring, performance management, and team development.
Travel Expectations
Up to 15%
EOE/M/F/Vet/Disability
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