Data Integrity Lead at GlaxoSmithKline Plc (GSK)

Job Responsibilities

• Leading the implementation of the data integrity culture, strategy, data governance framework and processes for the site and ensuring compliance with all applicable regulatory requirements at the system level.
• Implementation of the corporate and regulatory requirements of the Quality Management System.

Fundamentals: Safety, Quality, People and Process

• Oversee site compliance with the Quality Management System and regulatory requirements pertaining to data governance, including the development of indicators that monitor data governance processes and performance at the Site level.
• Develop and implement robust data governance practices, including routine management review of key data integrity metrics and risk model indicators, establishing data ownership and enhancing data analytics for the key risk area of Data Integrity.
• Provide support in the event of internal, external and regulatory audits, including potential direct interaction with regulatory agency officials on queries related to data integrity.
• Generate communication and work plans in order to ensure the prevention and detection of Data Integrity events.
• Participate in the gap analysis of the policies and procedures associated with Data Integrity, ensuring alignment of local SOPs with corporate requirements.  Also, serve as the site’s SME (Subject Matter Expert) and primary point of contact on regulatory intelligence and engagement activities related to data integrity and data governance.   Ensure site awareness and mastery of new requirements is complete and timely. 
• Continuously assess employee data integrity performance and understanding through internal inspection, training effectiveness evaluation, GEMBA and process confirmation.
• Gain deep understanding of data integrity incidents and ensure corrective and preventative actions are comprehensive and robust.
• Lead the program of Data Quality Culture at the site, taking a strong and visible role in embedding true commitment to data integrity throughout the site.  Advocate to drive implementation of changes which will make compliance easier.
• Manage the assignment of roles and responsibilities for the review, approval and execution of plans necessary to meet data integrity standards.  This includes coordination of the evaluation and, where required, remediation of new and existing electronic systems (IT, analytical, and production) to assure compliance with applicable requirements.
• Establish and lead an internal site network of DI champions and actively participate in the multi-site DI Community of Practice.
• In charge of implementation and maintenance of QMS on site in accordance to guidelines set by GSK Quality, Regulatory and in compliance with local requirements.
• Plan and coordinate activities of the QMS reviewers in performing QMS gap analysis, risk assessment on gaps and associated action planning.
• Supplier Management
• Manage site specific suppliers.
• Escalate significant issues to Supplier Quality Operations Team and provide supporting information to the Supplier Quality Audit Team.
• Coordinate the alignment of specifications through Product Requirement Specification management.
• Act as back up for Quality Compliance activities which include; Risk Management, CAPA Management, Auditing Processs

Complexity:

• Interaction with Regulators during regulatory inspections for Data Governance and Data Integrity.
• Making decision as per the policy to ensure the business does not suffer as well as maintain integrity during process improvement initiatives.
• Influences & supports team members with respect to process improvement through open & constructive consultation.
• Ability to influence decision through facts.
• Resilience as an individual and able to drive the same through open and honest engagements.

​Basic Requirements:

• Project Management.
• Analysis and Problem Assessment.
• Organizational, Planning and Prioritization skills.
• Report writing skills.
• Must be computer literate.
• Effective influencing skills at all levels of the organization and with external partners.
• Good verbal and written communication skills.
• Operate with a strong sense of integrity, ethics, responsibility and commitment.
• Result-oriented.
• Act with Integrity.

Preferred Requirements:

• Excellent interpersonal and facilitation skills.
• Desire and ambition to Improve Systems and Process.
• Strategic Thinker: - ability to think outside the box.
• Ability to communicate to all levels of team structure to enable and drive change.
• Experience in QMS and GxP Documents management is an added advantage.

Qualification/ Experience:

• Degree in Pharmacy
• High level of Communication/Business skills.
• Experience with people management, personal relations skills and ability to work under pressure.
• At least 3-5 years of experience in the Pharmaceutical Industry in Quality Assurance areas or area related, including a position of authority in decision making and management of documentation and / or IT
• Knowledge of documentation and electronic systems that generate and manage GxP processes.