3 Days Left! Senior eCompliance Manager

Job Description Summary

Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure. Provide oversight, and guidance in the development and implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within IT systems landscape. Closely cooperate with functional IT staff in the compliant development and delivery of computerized systems to meet GxP requirements.

Review and approve CSV deliverables for all Global GxP relevant systems including determination of GxP applicability.

Job Description

Key Responsibilities :

1.

Ensure implementation of the e-Compliance strategy and all applicable Novartis and regulatory requirements for all GxP regulated computerized systems and associated infrastructure.

2.

Provide oversight, and guidance in the development and implementation of Novartis GxP computerized Systems and processes, including on-going implementation of Data Integrity technical controls within IT systems landscape.

3.

Single Point of Contact for all CSV related matters for GxP Global Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.

4.

Establish trusted partnership with assigned IT Function with understanding of business drivers, strategic roadmap and its impact on the GQS eCompliance team.

5.

Review and approve project related documents for all Global GxP relevant systems including determination of GxP applicability. Review and approve High Level Classification & Consultation Document (HLCCD), standards and documents for all Global GxP and non- GxP relevant systems including determination of GxP applicability.

6.

Support the life-cycle of GxP computerized systems with periodic re-evaluation of the validation status, change controls, deviations management ensuring that relevant documentation is in place and maintained according to the Novartis requirements.

7.

Closely cooperate with functional IT staff in the compliant development and de- livery of computerized systems to meet GxP requirements.

8.

Provide the needed e-Compliance support for the Strategic Projects, audits and Inspections.

9.

Ensure that the KQIs are proactively managed.

10.

Support the development, maintenance and effective implementation of appropriate standards and non-contradictory processes for governing GxP computerized systems.

11.

Support appropriate benchmarking with industry for trends and changing regulations to ensure that the Novartis standards and requirements are sustainably maintained and aligned and compliant with current HA requirements and expectations. Integrate into internal NVS regulatory processes accordingly.

12.

Support the development and implementation of adequate eCompliance standards in established quality risk assessment processes to ensure that eCompliance and technical requirements for data integrity are adequately covered.

13.

Perform supplier qualification assessment activities.

Essential Requirements :

1.

GxP relevant computerized systems are developed, implemented and maintained according to the Novartis requirements and the project plan.

2.

Documentation supporting eCompliance and CSV requirements is in place, maintained up-to-date and can be presented during audits and inspections without delays and issues.

3.

Gaps in eCompliance and CSV activities are proactively identified, escalated and the development of mitigation plans supported.

4.

Gaps in the processes around GxP are proactively addressed with the help of the Process Managers and Process Owners.

5.

Client / stakeholder satisfaction and corresponding feedback.

Desirable Requirements :

Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.

Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments

Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments

Highly experienced in the operational management of GxP solutions including its related technologies to support the operation

Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)

Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP / SAP, MES, LIMS, CRM, IAM, etc.)

Successful cross-divisional / functional work with complex international teams

Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude

• Ability to effectively interact and present to Management, health authority inspectors;

Proven ability to influence without hierarchical authority and build trusted partnerships

Proven self-starter with experience in initiating and delivering projects and processes

Excellent communication, negotiation, facilitation, and interpersonal skills

Work Experience :

15-20 years of overall experience, and a minimum 10 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance

Education : Degree in Life Sciences, Pharmacy, Engineering or Information Technology; advanced degree preferred.

Languages :

Why Novartis : Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here : https : / / www.novartis.com / about / strategy / people-and-culture

You’ll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https : / / www.novartis.com / careers / benefits-rewards

Commitment to Diversity and Inclusion :

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here : https : / / talentnetwork.novartis.com / network.

Skills Desired

Agility, Agility, Auditing, Audit Management, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Compliance Audits, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness, Leadership, Logical Thinking, Major Incident Management, Organization Skills, People Management, Problem Solving Skill, Problem Solving Skills {+ 5 more}