Novartis Hiring for AD, Learning Systems Compliance at Hyderabad, Telangana Full Time

Together we will shape the future of Sandoz… are you ready to make a difference?

Position Purpose:
This position ensures that all the Learning Systems are operationally meeting all compliance, legal and audit-readiness requirements, maintained in a validated state and ensuring strict system adherence to both industry and company specific compliance requirements through change management, product releases of the vendor as well as internal projects. This role reports to the Business & System Owner, Global Director Learning Platforms, and partners closely with the Global Process Owner of Learning, Service Integration, Service Delivery, IT operations, Quality operations, and Program team. The role holder will also provide guidance in solving point-in-time challenges in case of major impact and partner with internal collaborators to increase the effective use and adoption of the Learning platform from GxP point of view.

Your Key Responsibilities:
Your responsibilities include, but not limited to

• GxP Systems

a. Assist in developing and documenting processes to improve efficiency for Learning systems & tools, as may be applicable in coordination with the Global Process Owner for Learning. Supports compliance with legal framework, SOX requirements, and Sandoz specific policies & guidelines. Manage all system life cycle documents in partnership with PQM and OQM.

b. Liaise with vendor quality for getting the required system validation documentations and maintenance of quality assurance agreement.

c. User access management- review and approval of Learning and System admin access requests after ensuring the individual meet the defined requirements.

d. Serve as the Subject Matter Expert on GxP for Learning systems.

e. Ensure that impact assessments of any deviations that impact the System Owner’s area of responsibility, are accurate and comprehensive and that CAPA are appropriate.

f. Participate in Risk Assessment and advise on its mitigation / reduction.

g. Develop job aids for applicable applications to upskill GxP capabilities within Learning Operations in coordination with the Global Process Owner for Learning.

h. Contribute to regular meetings with internal partners and make recommendations to provide continued improvement with processes, workflows, and system configuration.

i. Ensure, together with the Business & System Owner, that the system operates in compliance with all applicable internal and external regulations, policies, and guidelines, with the objective of maintaining the accuracy and security of all data residing within systems in scope.

j. Design and manage audit / inspection readiness strategy, governance, and process.

k. Serve as a liaison to all audit, inspection, and legal cases requests.

l. Monitor audit / inspection calendar and plan appropriate support in coordination with Global Quality and P&O Analytics & GPO Learning.

m. Advice on necessary procedures as provided to implement CAPA, system related deviations, quality assessments and assess the implementation.

n. Audit / Organize regular quality checks to ensure system compliance.

o. Identify process / system risks, advise, and develop solutions to mitigate risks, within organizational constraints.

p. Perform, review, and advise Business System Owner on periodic review activities related to GxP validated state for system.

q. Ensure documentation, processes and standards are maintained or created for the Learning platform(s).

r. Advice on training requirements within Learning CoE and extended P&O Technology executing validation deliverables and supporting the Learning systems as per their assigned responsibilities.

• Non GxP Systems

A. Ensure system compliance of Non-GxP Learning systems in scope, as defined by relevant policies and procedures

B. Ensure system integrity is maintained during projects, major / minor releases as well as during projects

C. Monitor / Organize regular quality checks to ensure system compliance for non-GxP applications

• Deputy of Business System Owner

A. Review, approve and sign-off business processes, User Requirements, design, and structure / data definitions for GxP and non GxP systems in scope

B. Review and approve all validation deliverables / lifecycle deliverables defined as per Validation Master plan

C. Participate in change request review discussion and provide approval as needed for applications in scope

D. Serve as a liaison to Learning System(s) quality assurance team in case of GxP quality related matter

E. Ensure legal hold and data retention guidelines are followed for all Learning applications (GxP / non GxP) in scope

Performs other tasks as assigned by Line Manager.

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

What you’ll bring to the role:Essential Requirements:

• Bachelor’s degree required. Human Resources discipline preferred, with In-depth knowledge and 5+ years of hands-on experience of GxP, Computer System Validation, Data Privacy and Compliance requirements
• Experience with HR cloud solutions, preferably learning management systems, talent marketplace, LxP etc. Experience of CSV Validation on any industry leading learning system will be added advantage
• Experience in pharmaceutical or life science industry, exposure to external GxP audits by regulatory bodies such as FDA, MHRA etc.
• Previous experience in cooperating with different stakeholders
• Demonstrated ability to work in cross functional teams in an international environment, passion for learning – Learning Agility
• Solid organizational skills including attention to details and multitasking skills.

#Orbit

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Why Sandoz?

453 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Division

SANDOZ

Business Unit

Global P&O SZ

Country

India

Work Location

Hyderabad, AP

Company/Legal Entity

Sdz Pvt Ind

Functional Area

Human Resources

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

No