Site Name: Hyderabad Wework Krishe Emerald
Posted Date: Mar 27 2023





Ready to help shape the future of healthcare? Uniting science, technology, and talent to get ahead of disease together GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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. Job Purpose* This individual will be the face of GSK quality at Tech Mahindra (Tech M). He/she will be accountable for implementing governance of and maintaining these relationships based on transparency and trust. He/she will provide the on-site Quality and compliance oversight of service activities ( data management, APS, MDM) in order to ensure GSK standards are met, to safeguard GSK\xe2\x80\x99s patients and to protect GSK\xe2\x80\x99s reputation. Key Responsibilities

• Responsible for building and maintaining the direct Operational Quality oversight and management of relationships with within the Tech M framework and across all mini BUs that offer services to GSK. This includes, but is not limited to records review (Deviations, CAPAs, Change Controls, Quality Improvement Plan) and approval, authoring and executing quality agreements, implementing governance, audit support, etc.
• Leveraging a strong relationship built on trust and transparency, coach, mentor and influence Tech M in order to increase quality mindset and maturity to safeguard the GSK patients, the quality of our products, and our reputation.
• Facilitate decisions concerning the quality of service and subsequent steps; escalate issues and risks that may have an impact on compliance in a timely manner.
• Identify and advance continuous improvement initiatives to ensure GxP expectations are met.
• Assure all quality issues are communicated and managed to GSK leadership in a timely manner; proactively identify and manage issues to ensure business continuity; work to quickly investigate and resolve emerging.
• Coordinate data collation and provide input to the Quality Council to promote quality mindset and governance.
• Build and maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
• Contribute to the evolution and implementation of GSK Quality Standards, the annual quality plan, and the overarching quality strategy
• Establish and maintain regular dialog with team members, individually and collectively, providing feedback and recognition.
• Effectiveness with measured by in-place/in-use Quality Agreement, GSK Corporate audits, delivery of successful regulatory inspections, and quality KPIs

Educational Background
Minimum Level of Education*

• Degree in Science or Engineering discipline and at least 8 year experience (Manufacturing, QC, Engineering, Validation or Quality Operations) OR Masters and at least 6 year experience AND/OR equivalency in education and experience.

Area of Specialization*

• Scientific discipline (e.g., Biology, Chemistry, Engineering)
• Well-developed technical, quality and supply chain knowledge

Why is this Level of Education Required?

• To assure ability to understand scientific & technical detail

B. Job-Related Experience
Minimum Level of Job-Related Experience required

• >7 years of previous Pharmaceuticals industry experience in technical or quality role(s) with at least 3 years Third Party Management.
• Sound understanding of quality systems and quality control processes
• >3 years of operational quality or compliance experience or other relevant experience
• Demonstrated knowledge of GMP\'s, FDA, EU and other regulatory agency requirements with an ability to apply to quality and compliance
• Demonstrated knowledge of quality system principles and practical applications.
• Demonstrated knowledge and ability to apply quality and risk management principles and tools.
• Demonstrated problem solving skills.
• Demonstrated ability to make grade level decisions based on facts and data and application of risk management principles
• Experience with work related travel
• Excellent written and oral communication skills -English
• Proficient presentation skills, able to address senior audience.
• Proven ability to manage teams
• Strong influencing and negotiating skills
• Demonstrated ability to develop and coach staff
• Capable of managing across boundaries

C. Other Job-Related Skills/Background

• Proven ability to function independently, as a self-starter, and prioritize work.
• Thorough knowledge of cGMP\'s and ICH guidelines; demonstrated ability to implement these guidelines.
• Demonstrated sound decision-making skills.
• Demonstrated ability to lead work and collaborate within cross-functional teams (matrix management).
• Strong verbal, written communication and presentation skills.
• Strong Project Management skills.
• Solid understanding of Quality System principles and practical applicable, including emerging expertise in deviations/investigations/CAPA and Change Management.
• Demonstrated problem solving capabilities, with preference to direct experience in application of Excellence in Deviation Management (EDM), Human Factors Analysis, and/or GSK Production System (GPS) principles.
• Strong interpersonal and influencing skills.
• Demonstrated flexibility, ability to adapt and accommodate different/ multiple work demands.

At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

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  LI-GSK

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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.