Manager - Quality and Cross IT Applications

Job Summary/ Main Purpose

The role Manager – Quality and Cross IT Applications provides compliance leadership and direction to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Infrastructure Qualification standards and practices. Role is responsible for ensuring that the IT processes, products, and services comply with the relevant IT standards (ISO, ITIL, COBIT, GDPR) policies, and regulations including GMP and other pharma standards.

Main Responsibilities:

1. Ensure computerized systems are appropriately documented and validated.
2. Subject matter expert on SDLC/Qualification procedure and able to provide CSV guidance to IT or Business.
3. Ensure alignment and compliance of the IT quality and compliance with the organizational strategy, goals, and values, as well as the applicable IT standards, such as ISO, CMMI, ITIL, etc.
4. Lead the team handling both Quality, Financial Audits (Internal/External) related to IT GMP and Non-GMP validation with the right kind of approach and strategy.
5. Coordinate with cross-discipline team members to ensure that all parties are on track with project requirements, deadlines, and schedules.
6. Plan and conduct internal and external audits and assessments of the IT processes, products, and services, and report the results and recommendations to the management and relevant parties.
7. Manage and coordinate the corrective and preventive actions and ensure their effectiveness and closure.
8. Set up Steering, Project committee and communication with the steering committee members and project sponsor.
9. Facilitate communication with the global team and help conflict resolution, if conflicts arise, escalate issues, and seek resolution.
10. Facilitate sign-offs and completion of trainings within the stipulated project timelines.
11. Help project teams define appropriate CSV strategies including stage gate deliverables.
12. Prepare or review all levels of validation documents (internal or external) including:
1. Validation (Strategy) Plans, User Requirement Specifications,
2. Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs,
3. Qualification Documents and Test Specifications (DQ, OQ, PQ, IQ),
4. Traceability Matrices, Risk Analysis,
5. Validation Reports, Change Controls/Events/Deviations etc.
6. Provide CSV technical sign-off for all the above.
13. Review, write, revise and maintain all IT related policies/SOPs (GMP/Non-GMP).
14. Provide training, coaching, and consultation to the IT staff and stakeholders on the IT Computerized System Policies, SOPs, best practices, and improvement opportunities.
15. Compile and analyze validation data and make recommendations for changes and/or improvements.
16. Work with the business system owners and teams to support internal & external audits across to confirm compliance of the system with local and regional standards.
17. Perform periodic reviews or re-qualifications to maintain current validation status of software and systems as defined by approved validation SOPs.
18. Manage, track, and monitor all the IT CAPA’s, Deviation and change controls.
19. Manage all Manufacturing/GMP Solutions, its contracts and documents.
20. Conduct Gap Analysis and develop Remediation Plans. Excellent knowledge and good working experience on preparing the Corrective Action Prevention Action (CAPA).
21. Manage routine IT change control and configuration process.
22. Routine IT Incident and deviation management.
23. Manage close cooperation with user department and suppliers for getting their extensive supports.
24. Keep abreast of the latest developments and changes in the IT standards, policies, and regulations, and ensure their timely adoption and implementation.
25. Identify, analyze, and report the IT quality performance, trends, risks, and issues, and propose solutions and actions for improvement.

Requirements (Knowledge, Skills & Attributes)

Essential:

1. Understanding of GxP and Computer Systems/Automation role in support of GxP compliance is required.
2. Proven knowledge and experience in applying and implementing various IT standards, such as ISO, CMMI, ITIL, etc. and relevant pharma regulations such as CFR Part 11.
3. Experience in SAP ECC, S4HANA, GxP, GMP, Reporting tools and EQMS solutions.
4. Experience with Technical Document writing (SOPs) and development.
5. Understanding of GAMP5 and risk-based approach to validation is required.
6. Experience in the review of Validation Deliverables (Project Documentation).
7. Ability to identify, define and propose the quality framework improvements based on daily challenges is desired.
8. Excellent communication, presentation, and interpersonal skills.
9. Experience of working with Pharma/Biotechnology.
10. Ability to manage and/or coordinate projects from start to completion in Quality Compliance field.
11. Participate on cross-functional teams to validate/verify, implement, and maintain regulated (Example: GxP, JSOX etc.) and/or non-regulated systems.
12. Proven experience with IT Risk Management and Control policies and procedures.
13. Proficiency in MS Office tools.
14. Knowledge in Documentation Life Cycle and Good Documentation Practices.
15. Experience in SOX controls - IT General Controls (ITGC) or General Computer Controls (GCC).

Desirable:

1. ITIL Certification and Experience.
2. ISO Certification and experience.
3. PMP or Equivalent.
4. Lean Six Sigma Certification.

Qualifications:

Desirable:

1. Bachelor’s Degree with 10+ years of IT Quality, computerized systems compliance and SDLC experience in life sciences/manufacturing is required.
2. Any key quality (GxP) certifications.