Assistant Manager - GxP

Job Title: Assistant Manager - GxP

Career Level -D1

Introduction to role

At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and collaborating to make the impossible a reality. We focus on the potential of science to address the unmet needs of patients around the world. We commit to areas where we believe we can truly change the course of medicine and bring innovative ideas to life.

Global Commercial Operations supports AstraZeneca’s global brand teams and marketing companies in delivering quality commercial content to external stakeholders, including doctors, healthcare professionals, and patients. We promote, produce, and publish best-in-class commercial content for marketers and our global sales force while embedding a digital compliance capability across the organization.

The Global Learning Services (GLS) team delivers significant business benefits such as improved learner experience, innovation & process optimization, analytics capability, and cost-effective, sustainable, and scalable learning solutions. GLS provides a single-entry point for managing learning administration for global learning systems. Process optimization increases simplification and standardization of learning processes and governance, exploiting innovation and automation wherever possible. Analytics capability enhances our ability to provide performance metrics and analytics – delivering better data insights and improving business decision-making. We provide cost-effective learning solutions and reduce the cost of learning administration to the business.

To deliver our Global Learning services vision, we are looking for an experienced Assistant Manager who will support learning initiatives by bringing key skills in GxP learning management, content development, and experience in creating and leading multiple phases of project life cycles.

Accountabilities

- GxP Computer System administration, support escalation point, and maintenance
- GxP Computerized System Request Management and technical investigation
- Creating SOPs, Guidance Documents, and Work Instructions
- SME who partners with QA on managing GxP enterprise applications throughout all phases of the system development lifecycle, including concept, design, implementation/validation, and operation
- Information Systems SME and a representative that serves as a Project Manager
- Supporting account management, routine user access reviews, and release management for GxP regulated systems
- Effectively interface with system business owners of GxP systems and provide technical support
- Effectively interface with vendor support and maintenance & operation of the GxP systems
- Staying current with US and international regulations, industry standards, and emerging topics pertaining to GxP, GCP, and GMP etc.
- Preparing, reviewing, and approving GxP Computerized Systems Validation lifecycle documents as an IT SME
- Understanding, analyzing, and documenting GxP/GMP frameworks
- Documenting the defined processes and strategies
- Understanding existing processes, SLAs, Incident and Change Management, and facilitating communication between stakeholders, learning partners, and Learning Services teams
- Building relationships with stakeholders, learning partners, and Learning Services team throughout the project lifecycle and establishing communication channels
- Emphasizing the importance of continuous process improvements and service delivery
- Forecasting and coordinating with Learning Services teams and Business
- Leading projects from requirements definition through deployment, identifying schedules, scopes, and implementation plans, including risk mitigation
- Ensuring the projects adhere to scope, schedule, and risks/challenges
- Ensuring an effective Risk & Issue management process and reflecting on lessons learned to identify best practices to apply in the future
- Setting up GxP Governance visibility for Learning Partners & Business through business review meetings
- Supporting the definition of Standard Operating Procedures related to end-to-end processes
- Versioning and updating processes, procedures, and policy documents
- Scheduling the expiration of courses and assets if appropriate
- Work with senior management to ensure completed projects, courseware, and LMS/training systems meet users’ expectations
- Work with team members to define processes, workflows, effective content production, and implementation of up-to-date development and LMS technologies and methodologies
- Support and maintain the global knowledge base and repository for best practice documents, key tools, and templates
- Onboard new hires to their role and ensure timely readiness
- Manage a team of 8 to 10 members
- Provide coaching/mentoring and performance development for their team members.

Essential Skills/Experience

- Bachelor’s Degree preferred (Academia: Computer science, Engineering, technology)
- 10+ years related experience
- Experience in Learning platforms like SABA, Cornerstone, SuccessFactors
- Minimum additional 3 years of experience supporting GxP (GMP, GLP, GCP) computerized systems
- Project management skills including scope definition, risk assessment, estimating, and reporting; ability to prioritize and complete tasks; strong time management skills
- Good people management skills
- Full understanding of best practices, rules for regulated and validated (GxP) systems
- Excellent time management skills with the ability to organize and prioritize effectively
- Strong analytical skills, ability to create viable solutions, innovation, and ability to execute flawlessly
- Strong oral and written communication skills
- Customer focus and organizational awareness
- Experience in resource/stakeholder management 
- Ability to manage strict timelines, escalations & ensure quality of deliverables 
- Proficient in partnering with stakeholders/team members from different levels of multiple teams who are geographically dispersed.

Desirable Skills/Experience

- Ability to apply structured problem solving (taking a large complex problem and breaking it down into components)
- Experience in the Pharma industry
- Proficient in communicating organizational policies and procedures 
- Experience in Change Control, incident response, and release management 
- Ability to set vision and drive tactical execution 
- Impactful stakeholder engagement experience across multiple regions 
- Strong working knowledge of Microsoft Office Suite; advanced PowerPoint user (visuals, graphics), Advanced Excel 
- Willingness to accommodate different time zones 
- Team skills including the ability to establish effective working relationships within the organization 
- Strong understanding of the pharmaceutical/healthcare industry 
- Knowledge of instructional design and adult learning principles 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work on average a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you will be part of a team of specialists that is valued and essential to our growth. Our role is crucial during this time of evolution for AstraZeneca. If you want to make an impact, this is the place to do it. We are encouraged to apply entrepreneurial thinking in a creative yet rigorous environment. Our strength lies in our global network where we work seamlessly together. The business is committed to investing in our growth. Whether deepening our expertise or expanding our horizons keeps us ahead of our peers. We are driven by challenge and change.

Ready to make a difference? Apply now!