Years of Experience: 20+ Years
Work Location: Bengaluru
Key Responsibilities
Direct accountability for developing and implementing quality strategy to oversee data quality:
Oversees the incorporation of new technology and innovation (Biostatistics, Digital Health, Data Management, eConsent, eMedical records, eCOA) in drug development.
Oversees the development and implementation of digitalization strategy.
Engage with management and cross functional business partner to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement.
Considered a strong trusted partner with R&D and Tech leaders; consulting with those stakeholders to understand needs and determine priorities.
Support the business in ensuring quality by design and to enable the execution of external regulations, guidance and internal standards.
Works with QuRE data analytics team to define KPI, KQI and metrics needed for QuRE and stakeholders.
Provide input into global audit plan based on identified signals/trends/risk/gaps.
RepresentsQuRE in committees and governance meetings.
Ensures ongoing inspection readiness in the area of responsibility and implements required activities, supporting the preparation, execution and close out of inspections.
Provide quality advice and GxP validation expertise within the functional & process area.
Ensures rapid communication of critical quality issues and risks including potential misconduct to appropriate business partners and leaders.
Supports the investigation of potential serious breaches and critical issues.
Participate in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.
May influence the external environment through interactions with regulators, trade associations, and professional societies.
Education Requirements
Bachelor’s degree or equivalent in scientific, engineering or quality-related field or equivalent combination of education, training and experience.
Job Related Experience
Extensive experience in pharmaceutical industry, medical device industry and/or quality assurance.
Demonstrated knowledge of GAMP5, ISO, GLP, GCP, pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organisational and planning skills.
Broad knowledge/expertise of IT development lifecycle model and of world-wide accepted IT validation standards (GAMP or equivalent).
Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedures e.g. Lean Six Sigma, Scrum, Hoshin Kanri, Scrum
In-depth knowledge of worldwide regulations and guidelines e.g. 21 CFR part 11, ICH, PIC/S, OECD
Advanced knowledge of potential use of technology solutions in a business environment including cloud computing, AI/ML
Other Job-Related Skills
Desired:
Experience in supporting regulatory authority inspections.
Ability to work effectively in an international multicultural matrix organization.
Effective communication/negotiation skills and customer management skills
Other:
Travel: Bases in business need
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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