Quality Systems and Data Manager

Are you looking for an opportunity to be a leader in data strategy and compliance for a multi-national pharmaceutical company?  If so, this is the role for you.

The Quality Systems & Data Manager provides leadership to a team of Quality professionals critical in overseeing data integrity and governance, training compliance, Quality Management System (QMS) deployment and enhancement, as well as defining and driving the site Quality Improvement Plan. The role also includes responsibility for driving GPS for Quality, Quality Culture and embed Digital Strategy into the site. The Quality Systems & Data Manager reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Responsible for creating and driving the Quality digital strategy in collaboration with site and central functions.
• Provide leadership and strategy for site data integrity & governance program.
• Uses lean six sigma methodologies to advance systemic quality improvements thru the GSK production system.
• Ensure comprehensive training compliance for all relevant personnel, maintaining up-to-date training records and facilitating necessary training programs.
• Manages implementation of local updates to site quality digital systems including VQMS, MERP through appropriate change management procedures.
• Develop, implement, and monitor the Quality Improvement Plan, driving continuous improvement initiatives.
• Collaborate with cross-functional teams to ensure alignment and integration of quality systems and processes, including implementation and maintenance of the Quality Management System (QMS).
• Maintains a thorough and current working knowledge of compliance requirements and policies, FDA regulatory developments and industry trends and ethical pharmaceuticals.  Provides interpretation of regulatory quality and compliance requirements and ensures integration into site quality systems.
• Actively participate in the Quality Leadership Team (QLT) to contribute to the overall quality strategy and objectives.
• Drive initiatives for Quality Culture at site.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors degree
• 10+ years experience in pharmaceutical or biopharmaceutical or device manufacturing
• Experience in Quality Assurance

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor’s of Science in Life Sciences OR  Computer Science OR Statistics OR Information Systems OR engineering
• Data Visualization Analytics and AI /ML 
• Continuous Improvement: Lean Six Sigma/ Green belt or Black belt certification
• Background in highly regulated and complex environment, ability to effectively manage workload
• In-depth experience in quality systems, including validation, compliance, and running a high volume, rapid turnaround operation
• Strong technical understanding of industry and science practices related to the business
• Strong interpersonal and leadership skills
• Solid team player able to function within team-based organization
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, finance and EHS
• Effective at implementing decisions

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

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