Job Description

Reference #: 407411 Site Name: Bengaluru Luxor North Tower, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Pennsylvania - Upper Providence Posted Date: Nov 6 2024 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way. GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable. If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in "gsk.com", you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine. GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Job Tags

Similar Jobs