Senior Specialist Written Standards & Training (CDI)

Job purpose:

The purpose of the job is to ensure the quality and timely implementation of the end to end Written Standards and Training (WST) change request process, according to the defined standards and systems, as well as for the continuous improvement of that process with focus on efficiency and innovation.

The individual will supervise the activities of the WST administrative staff for the SOE and GMP Documentation and Training areas, who are responsible for maintaining lifecycle of Written Standards, for assigning training to impacted staff and maintaining training curricula. In this context, the WST Operations Manager ensures oversight and balance documentation vs training resource efforts to ensure a high quality and timely support

The individual will manage Written Standards creation/update/retirement processes as well as training development/assignment/delivery processes in line with WST standards.

In addition, the individual will be responsible for the execution of the R&D WST strategy ensuring high quality service delivery by vendors/service providers supporting Written Standards lifecycle management, training assignment, delivery of reports out of Written Standards & Training systems etc., in line with the established Service/Operational Level Agreements.

Your responsibilities :

In this role you :

• Strive for efficiency of operations daily-work assignment process across the WST streams and provide oversight of the WST Operations workload
• Ensure oversight of activities and processes impacting R&D departments at local level
• Contribute to a continuous improvement of the WST way-of-working and processes
• Liaise with the WST Managers to ensure feasibility of Change Request training strategy implementation in the learning system
• Ensure innovative training approaches can be made operational in the Vaccines R&D environment in a joint effort with the Training Excellence Manager
• Drive training strategy in collaboration with WST Managers throughout major/transversal projects in R&D
• Ensure collaboration and sharing of good practices with organizations outside R&D Vaccines within GSK (e.g. across RDC/Platforms, Corporate, Vaccines, Pharma, GIO or Sites)
• Ensure prompt management of issues encountered by users e.g., concerning training assignments
• Evaluate the Transversal WST requests (e.g. across RDC/Platforms, Corporate, Vaccines, Pharma, GIO or Sites) impacting Vaccines R&D and communicate to impacted WST Managers
• Ensure required WST front line support is in place to support Vaccines R&D for audits and inspections also coordinating the WST administrative staff responsible for the delivery

Why you?

Basic Qualifications :

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Relevant Bachelor and/or Master of Science Degree from recognized University
• Process design and simplification, Learning and Education
• At least 6 years of professional experience including at least 4 years of relevant experience preferably within Pharmaceutical R&D
• At least 4 years of proven experience of individual responsibility for developing, managing and delivering outcomes to deadline within a project.
• Relevant experience in quality management, compliance, quality assurance, regulations/Written Standard and Training management.
• Previous matrix team experience
• Organizational awareness.

Preferred Qualifications:

The following characteristics are assets (nice-to-have):

• Ability to successfully manage vendors and third parties collaborating on distributed complex processs
• Superior interpersonal and influencing skills – to facilitate optimal interaction between Platforms/R&D Centres and Portfolio Integration and Operations (PIO)
• Expertise in the areas of Quality and Project Management
• Result driven and able to motivate or inspire both junior and senior staff
• Has a “can do” attitude, helping the organisation to deliver stretch goals
• Demonstrates integrity, strives for excellence in her/his work
• Ability to manage and coordinate multiple projects simultaneously
• Comfortable and adept at managing a rapidly changing environment and adapt organization plans and priorities to address business and operational challenges
• Adept at simplifying complex concepts and able to communicate them simply to diverse audiences
• Experience in a training and/or written standards environment is preferred

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.

For further information, please visit www.gsk.com.

Our department:

Vaccines Global Quality is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.

At GSK we value diversity 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.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

• Li-GSK

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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