GSK Hiring For Senior Manager – Governance Risk & Compliance Bengaluru, Karnataka Full Time

Site Name: India – Karnataka – Bangalore

Posted Date: Aug 10 2020

Senior Manager – Governance Risk & Compliance

Full-Time, Bangalore, Karnataka, India

GSK is one of the world’s foremost pharmaceutical and healthcare companies, and we are proud to be part of an industry that improves the lives of others. We are embarking on a significant transformation journey that will support GSK in becoming a top-quartile data-enabled organisation.

This role will provide YOU with the opportunity to lead key activities to progress YOUR career. Responsibilities include some of the following.

Risk Management

Contribute to identification and initiation of Risk mitigation projects to address significant risks impacting a Business unit, using Smart Controls assessments

Facilitate risk identification and risk discussions within the business unit, both operational risk, product/project and strategic risk

Ensure emerging risks are identified and escalated appropriately and in a timely manner

Governance Risk & Compliance:
Monitor deliverable quality, ensure quality standards are being met for products/ projects, programmes or operations within their remit, following a risk-based approach, according to ITMS, Smart Controls assessments, local SOPs and projects PQPs

Contribute to providing Project Quality assurance oversight depending on the specific project risk profile, including specific assurance reviews as requested by stakeholders

Ensure Business Unit activities align with Regulatory requirements and liaise with Business Quality Groups to contribute to the overall GxP validation or Sox status of the business-facing application systems or services

Contribute to ensuring Business Unit is keeping up with regulatory and legal requirements through a pro-active knowledge management programme

Management Monitoring/Independent Business monitoring (MM/IBM)

Execute relevant self-inspection programmes within remit through Management monitoring and Independent Business monitoring where required

Support implementation of relevant Management monitoring programmes in Business Unit for processes not owned by TSR GRC

Audit Support

Contribute to ensuring Business Unit is ready to host external inspections from regulatory bodies (FDA, EMEA, tax authorities, external (Deloitte) and internal auditors (A&A, GCV, CSQA))

Support management of overall Business Unit inspection readiness activities and CAPAs in liaison with the business

Report status on CAPA’s to Business Unit RMCB

We are looking for professionals with these skills to achieve our goals. If you have them, we would like to speak to you.

Overall 10 years with a minimum of 5 years’ experience in a combination of Quality Assurance and Compliance function in a Pharmaceutical environment

Strong experience of CFR Part 11 and Computer System Validation

Demonstrable ability to understand new technology, develop new risk control framework for emerging technology (ie Cloud / Automation / AI/ML)

Thinking agility to apply an existing understanding of controls to new technology demonstrating smart risk-taking

Strong understanding of the regulatory trends in the Pharmaceutical industry is foundational to success in this role

Experience of working in cross-functional teams located globally

Awareness of the regulatory trends within the Pharmaceutical industry

Good knowledge of Software Quality Assurance

Understanding of ITMS, Smart Controls and how a business unit deploys this methodology (if internal candidate)

Experience of operating in an international environment with tact, diplomacy and cultural sensitivity

Experience in interpreting policies, procedures and processes for ensuring compliance with risk management programs

Knowledge of Tech Support processes, such as ITIL

Understanding of Agile, Kanban and Scrum basics

Good understanding of emerging technology eg cloud (SAAS, PAAS and IAAS), Automation, AI/ML, etc

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance and trust.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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