Sr Manager Regulatory Systems &Processes
PM
Sr Manager Regulatory Systems &Processes
Poznań
Type of work
Undetermined
Experience
Senior
Employment Type
Permanent
Operating mode
Office
Tech stack
Business Analysis
Project Management
Agile
Job description
The Senior Manager, Regulatory Systems & Processes is accountable for designing and delivering the roadmap that will improve the user experience for the product(s) within their area of expertise and support the company's strategic intent.
In this role, the position holder will be responsible for ensuring continuous improvement and innovation of GSK Regulatory systems and processes within a given area.
This role will include the leadership of global matrix teams.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Operate as a product owner, collaborating with business stakeholders to translate customer requests, competitive activities, and industry trends into value drivers of new sustainable technology solutions and product requirements that can be easily understood by product teams, developers and other key constituencies within the R&D organisation.
- Plan and prioritise projects and activities effectively to ensure maximum value delivery against GSKs strategic goals.
- Partner with other RP&S teams, GSK Tech and external vendors to optimise the delivery of functionality to the business to enable further operational efficiency
- Contribute to the product roadmap and key agile ceremonies.
- Complete ‘hands on’ configuration or development as required by the role
- Contribute to the Regulatory Change Control process and ensure compliance with internal security and risk management policies and practices, as well as external regulatory and statutory requirements e.g. GxP, IDMP
- Be an effective change agent/champion, supporting both the product team(s) and the business in agile approaches to solution development and adoption, building excitement, momentum, visible success stories and clear value based versions of vision as roadmap plans come to life.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Master’s Degree (Scientific or technical)
- Demonstrated Business Analysis skills to effectively evaluate the current business processes and systems landscape and identify both solutions and areas of improvement
- Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects
- Demonstrated Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers
- Knowledge of the scaled agile framework and guiding principles
- Experience working within a complex IT system landscape with colleagues from GSK Tech, Quality and Training organisations to deliver GXP compliant systems
- Ability to manage and motivate matrix teams in a globally diverse organisation
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Extensive experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures
- Ideally holds a Scale Agile PO/PM qualification
- Ideally have completed BA level Veeva Vault training
- Ability to define and implement new processes and solutions with an awareness of relevant controls and impacts.
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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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