포스팅 날짜: Apr 10 2025
Manager, Regulatory Operations
This role serves as the Business System Owner (BSO) at GlaxoSmithKline (GSK) for our User Access Management (UAM) application and our X-Vault platform and is responsible for overseeing strategic management and continuous improvement of these systems. This role ensures that UAM and the X-Vault platform are effectively supporting global regulatory operations, compliance, and business objectives. The BSO also fosters collaboration with other BSOs and systems, drives innovation, and ensures alignment with GSK’s regulatory strategy. By optimizing the performance and integration of regulatory systems, the BSO enhances operational efficiency, data integrity, and regulatory reporting, ultimately supporting GSK’s mission to deliver high-quality products to patients worldwide.
Locations: Poland (Poznan), Mexico City, Canada (Milverton)
Key Responsibilities:
- Provide operational support and strategic direction to GRA for Regulatory Systems & Processes
- Define system procedures, including reports, to support Business Processes effectively and manage change control procedures to ensure full impact assessment and robust implementation of change
- Monitor ongoing user requests and system activity to identify and act upon potential quality issues or process improvement opportunities
- Deliver and lead the ownership and business support for a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities
- Acts as the (SPOC) Single point of contact for issues arising on projects within remit of role and takes complete accountability in bringing them to appropriate resolution
- Manage business, project, and support challenges globally
- Lead the interface with IT, Business System Owners to coordinate solutions delivery and support
- Develop project proposals and business cases to address the tactical and strategic needs of the business
- Lead the business engagement in projects in collaboration with IT and Business Project Teams
Why you?
Basic Qualifications:
- Master’s degree in computer science /BE in computer science completion in IT / Science / Technical area of specialization
- Experience delivering business operational support and strategic direction for critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labelling Management Systems)
- Lead Business Change Teams delivering IT solutions for the business
- Drive support assistance and support on both sides of the Business-IT interface
- Significant experience managing system ownership including change control and system lifecycle management within a regulated environment, ideally in drug / vaccines development
- Experience developing solution based on business analysis needs and external drivers
- Fluent and able communicator in English and local language
- Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers
- Strong communication and influencing skills
- Ability to self-manage the work and prioritize effectively
- Service orientation, customer-focused
- Good team worker, but with confidence to lead when appropriate
- Good understanding of IT lifecycle, processes and quality management
- Software and System Experience (any):
- Veeva Clinical Operations and CDMS Vaults
- Veeva Regulatory Vault
- PowerBI, SharePoint
Why GSK?
At GSK we offer a wide range of additional benefits:
- Career at one of the leading global healthcare companies
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible
- Sports cards
- Possibilities of development within the role and company’s structure
- Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day
Inclusion at GSK:
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
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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.
GSK is an Equal Opportunity/Affirmative Action Employer. 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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