Vishnu Teja Mucharla

QMS elements:

Lead to drive the design, strategy, and execution of Sandoz GCC hub's GxP and Quality Operations end to end with an independent team reporting to Head GQS Sandoz.

• Lead End-to-end Spin off activities, Orbit project, Quality Assurance (QA) and Compliance activities within the Quality Operations teams at Global Quality Solutions International (GQSI) - GCC of Sandoz.
• QAA’s and Contracts review and sign the GQSI Contracts as Responsible Compliance and QMS lead.
• Develop, approve, and implement the GQSI Quality Plan, Self-Inspection Plan, Data Integrity Plan and Training plan inline to the global Quality documents, to implement proactive compliance and prevent risks at source.
• Design governance process, align and approve the Quality KQIs and KPIs for GCC Quality Operations,
• Approve and establish a simple and minimal error allowing methods to manage Investigations, Complaints, Deviations, Quality Events, CAPAs, EC's and Change controls management at GCC’s related to transitions and regualr operations. This helps in preventing the errors at source.
• Work with Global Emergency Management teams to handle and complete any notified escalations within GCCs of Sandoz.
• Design, review and conduct Management review meetings (MBRs, QMRs, Quality Board review meetings representing the GCCs in global Quality forums).
• Functional representative to review and contribute the Global Quality Modules (QM’s) and Quality Directives (QD’s) improvements and implementation based on the data and advancements.
• Archival and Retention: GxP Data and Documentation Management – Archival tools development and implementation – Developed Business Ready Tools (BRT) called LCD (SharePoint based Validated repository to easy archive and retrieve the GxP Data inline to CSV requirements/
• Exit Process development and integration with other GxP IT tools at Sandoz.

IT system Compliance:

• Define the User onboarding and off boarding process and ensure the GCC associates are adhering to the same.
• Ensure the associates are identified as Key Users and manage the lifecycle changes of GxP tools is very well executed without any compliance gaps.

Audits and Inspections:

• Design, Lead and Implement audits and Self inspections and its readiness on an ongoing basis inline to organizational QMS as Compliance lead.
• Global Internal compliance audits : Define Audit preparation plan, align with Auditors and support the GCC Quality Operations to execute the preparedness of internal and external audits and its successful implementation at GCC Sandoz Hyderabad.
• 3rd Party contracts review and approval for hiring Contractors/Contingent workers (MSA review, SOW sign off etc).
• Vendor qualifications for GxP Services suppliers (Vendor criticality assessment and Vendor Audits etc) as needed.
• Gather and continuously monitor the Risks identified, evolved and reported at GCCs via efficient Quality Risk management templates and Quality Plan execution.
• Proactively plan and monitoring the defined KQI/KPI metrics to meet the overall quality and compliance of GCC’s (GQSI-Quality Operations.)
• Transitions compliance: Developed the Process, Procedure, framework, governance that are relevant to successfully onboard the GxP transitions related to GCC hubs (GQSI India) from other parts of organization and maintain its (Procedure, GxP Checklists, DI checklists, KTs, SLAs, Trainings and Go-Live) end to end compliance.
• Review the contracts and draft the SLA requirements and constantly monitor the Volumes Vs Deliveries compliance.

Data Integrity

• Data Integrity Officer representing GCC-GQS functions (all locations): Work with Global Quality Leadership team at Sandoz.
• Accountable, Lead and define the Data Integrity governance set up, Data Integrity Assurance (DI assurance), DI training content review, implementation and monitoring the complete lifecycle management of DI and its related activities across GQS entities and within Sandoz via local DI plan.

Training Compliance

• Qualified Training program execution at GCCs as Qualified trainer.
• Training Matrix approvals, Training effectiveness reports, Training KPIs, Training Compliance management
• Design the QMS related to workshops and trainings (Game based learning via adult learning principles that constantly ensure the associates are trained in new ways of learning rather using traditional ways of learning.
• Define, lead, and implement GxP quality standards, systems, and governance processes for operations centers and GQSI activities

Procedural Compliance

• Review and approve Quality Operations in GCCs have created procedures inline to global leading procedures.

Clone, Create/Review and approve GxP documents and reports like SOPs, WPs, FRMs, ATTs, GUID’s, Deviation trends, quality event trends and investigations, wherever needed.

• Develop a proactive compliance monitoring method that alerts the procedural overdues well advanced to ensure no procedure is overdue.

Data Analytics and Continous Improvements (Simplification)

• Simplify the data reporting and visualize the date generated data into meaningful insights using Qliksense and Power BI and execute the Quality monitoring meetings.

Train the associates on DMAIC tools that would help them implement tools in day to day operations to reduce redundancy and improve efficiency.

• Identify and implement continuous improvement initiatives to all identified areas of improvement that in turn increase operational efficiency and competitiveness of compliance activities.

Diversity, Equity & Inclusion (DEI Sandoz India)

• Implement the DEI roadmap (Diversity, Equity & Inclusion) via leading the Volunteers group comprising of 40 associates across the GQS/GCCs in India and World.

Resource Management

• Optimize resource utilizationaccording to business priorities, collaborating closely with operations, STO, countries, and other quality organizations in Sandoz.
• Drive talent agenda: Lead talent development initiatives, including recruitment, training, coaching, and performance management, to meet operational requirements and improve diversity.
• Supports a robust succession plan for the organization.
• Engage and motivate the organization and deliver strong results with an empowered team.
• Drive the cultural development of GQSI-GCC building on speak-up, trust, empowerment and accountability.

Psycological Safety: Created and maintained a psychological safe environment to my associates/team, which is non-judgemental and growth driven

Develop and implement DI foundational strategies across Novartis functions, platforms - QSC, GOC and CTS in India and across countries and entities to create a DI culture below:

• Positive impact DI behavior by associates
• Identify and help remediate challenges for associates and reduce issues by 10% than previous years.
• Enable constructive discussions with associates
• Promote clarifications and disclosure of issues
• Improve DI Compliance

Impart relevant trainings and enable the global DI Strategy by leading following pillars below:

• Governance for DI
• Educate and Communicate
• Small Group Discussion - A goal to cover 500 plus associates
• Detect and Mitigate Risk
• Technology and IT Systems

Establish a local DI network to put approved plan into actions.

• Develop/Implement Training curriculums and maintain Quality management systems, related processes for GxP activities in QSC and NTO GOC teams that are aligned with Novartis Quality Manual, Global Standards and any other regulatory requirements.
• Ensure Quality Risk assessment is carried out periodically and risks are managed effectively in QSC and NTO GOC India.
• Collaborate with SMEs and Operational Managers to define, implement and maintain training curricula’s and matrix for QSC, GOC team in close coordination with GOC Training and Learning team.
• Create various KQI’s/metrics for KQI’s and respective GxP activities for NTO GOC, QSC and CTS for presenting in relevant forums. Investigate and mitigate gaps identified in QMS and Training system for QSC and NOT GOC.
• Prepare and Host the MIS meetings Quarterly and Annually.
• Author and approve the standard operating procedures that define the guidance to service teams to ensure compliance across business operations.
• Perform resource allocation/s on project activities and their utilization for projects/services.
• Define, review and validate the service deliverables and its analysis, and provide recommendations based on the project or service level requirements.
• Lead the Data Integrity team and drive the QSC and GOC India to accomplish the aligned global DI action plan.
• Establish compliance network groups to ensure the monitoring of compliance in larger groups of 900 plus associates.
• Execute and implement global change plan, process and activities compliance across multiple projects.
• Act as administrator for LMS, Cornerstone, Documentum systems like ESOPs D2 and Condor and ensure JD document lifecycle is managed as per the Novartis QMS requirements.
• Host trainings on GMP/Data integrity and other relevant trainings, as required for larger groups.
• Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP’s, Investigation reports etc., where required.
• Ensure all time readiness of the QSC/NTO GOC teams and other GxP activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs.
• Conduct/support Self-inspections as per the approved Self-inspection plan for QSC/NTO GOC and CTS, as required. Initiate and implement quality improvement/simplification projects within QSC, NTO GOC and CTS organizations in Novartis.

Projects and its transitions Accomplished:

• Onboard the services related to Change control/ Complaints/Document Management service transitions as Subject Matter Expert for following sites of Novartis:

• Cell for Cure/Les Ulis France (Cell and Gene)

• Torre S.p.A Italy. (Drug Product)

• D.S Schaftenau (Drug Substance)

• Cell Chain Management (Basel, Switzerland) – Cell and Gene closed supply chain

• QMS Migration (TrackWise to Agile Change Control Management) in Sandoz organization and Novartis Country Pharma Organization (70 plus countries).

• Expanded cross-functional organizational capacity by collaborating across departments on priorities, functions and strategic common goals.

• Continuous Improvement initiatives approved savings are below:

• 2019 $ Savings to the organization: 17K

• 2020 $ Savings to the organization: 50K

• Projects using Lean techniques that has impact on various internal organizations are below:

• Qlik based automatic dashboards

• Excel based dashboards

• PowerApps Application – QSC PROTON

• Leadership Training and Certification: M1 Lead the Way certification on going.

• Six Sigma Green Belt Certification on going.

• Lead the Account of Mondelez International Pvt Ltd (Cadbury's parent company) with a team of 23 people, to define the responsibilities, hiring and assign them to the client account.

• End to End management of team set up from project sign off, legal documentation validations, Resource deployment.

• Define business performance metrics and measure attainment to drive decision making.

• Guide process optimization, Governance and KPIs set up.

• Regularly report the associates’ deliverables and provide the deliverable quality reports to senior leadership.

• Liaison between companies Legal, Finance and Management to ensure account is compliant and smoothly functioned.

• Ensure the Master Services agreements (MSA’s) and Statement of Work (SOW) and other contractual document compliance.

• Document business cases and requirements to meet business objectives.

• Inclusive of data centric experience design in compliant manner that act as reference to stakeholders within regulated environment.

• Coach and Mentor the team to ensure the delivery KPIs are never missed.

• Develop a robust onboarding, training and transition plan for such regulated services to achieve expansion of projects for ad-hoc requests within the account.

• Change Control management for as CPM and SPOC (1200+ change controls as CPM)

• Novartis External Supply Operations (CMO changes)

• Novartis Site: Stein Sterile

• Novartis site: Morris Plains (Cell and Gene Therapy Unit)

• Established strong baseline for team with ESO and Novartis internal manufacturing sites to make sure operations related to Change Control Service are reliable and value add.

• Managing all change controls related to product, admin and asset categories as change phase manager/change project manager.

• Setting up business with ESO, Stein, Morris Plains, Huningue etc. other global manufacturing sites of Novartis.

• Worked on Regulatory, Supplier, LCI, Master Data, Assets, Administrative change controls for all internal Novartis functions where Agile is QMS system for change management.

• Drive the Change Review Board set up and facilitation for assigned sites.

• Develop dashboards based on Excel, Qlik that monitor KPIs and other process areas that are key to KPIs achievement.

• Querying in Agile system to provide data that shall be presented at Quality Review Boards at sites every month.

• Train associates at sites for system, develop collaborative process documents.

• Expert in managing DRAGON, SUBWAY which are quality and regulatory information management systems on Novartis.

• Reporting the status in weekly governance meetings to adhere to the aligned KPIs.

• Novartis Consumer Health Pvt Ltd – Compliance Associate II (External)

• As onsite Compliance associate to Novartis for Regulatory Information management for consumer health portfolio of Novartis.

• Update the current and latest regulatory parameters registered for each product in RIMS (Aris Register).

• Contact each Country Regulatory Leads of all marketed products and update the latest submitted and approved registered parameters for assigned portfolio.

• Draft and share the Regulatory commitments to Country regulatory leads based on HA requirements.

• Update the regulatory product dossiers of each registered product to reflect all renewal package information registered and updated data elements of product over the years.

• Approve the documents in SOP manager and TEDI as Key user/Doc manager for assigned portfolio.

• Monitor the regulatory questionnaire and respond to the questions related to the assigned products.

• Manage the change controls related to regulatory changes, liaise with stakeholders to gather the assessment and update the summary and define actions relevant to change controls assigned.

• Monitor the documents lifecycle status and initiate the technical workflow and update the documentation and get it reviewed and approved in OTC Docs.

• Review the renewal submission package readiness.

• Mentor and train the new associates to onboard them.

• Support internal and HA audits as SME.

Johnson and Johnson – Senior Associate (Consultant)

• As offshore technical consultant for UK Maidenhead office for Regulatory dossier writing (CMC- Module 2, Module 3) that submitted to EMEA and FDA as part of MAH license holder responsibility.

• Manages Change requests as regulatory and Compliance SME,

• Write Quality CTD module for EU region and US region.

• Work on Regulatory Information Management systems to keep up updated regulatory data for products licensed.

• Testing developed GxP systems, identify and log identified bugs in bug log sheet to ensure GxP application is released with no bugs and ensure IT compliance.

• Act as primary contact for Compliance management professional for Novartis OTC division as offshore consultant.

• Worked on CTA submissions for Listerine product in UK.

• Worked with multiple projects as Project Coordinator along with regular deliverables.

• Part of technical GxP process level discussion in setting up services.

• Initiator of Innovation and Great Place to Work communities in organization that focus on healthy and productive culture Within organization.