PROGRAMME QUALITY MANAGER

Descripción del puesto.
As Programme Quality Manager, you will provide oversight and input to cover the qualification/validation of computerised systems according to (COMPANY NAME) SOPs and external regulatory expectations with an emphasis on SAP 4/HANA implementation.
You will be responsible for ensuring that the SAP 4/HANA implementation complies with (COMPANY NAME) quality management standards and procedures for this major business transformation.
You will have a relentless passion for quality excellence and a strong customer focus.
Working with the core team and local organisations, you will be accountable for assuring that the processes and systems are compliant at both the global level (global processes) and the local level (localizations).
This includes engaging with senior stakeholders within the business, IT, and Quality functions to ensure that quality and compliance are embedded into the culture, design, and methodology of the programme, balancing quality and compliance requirements with the need for agility and flexibility with conformance to standards.
Accountabilities * Developing and implementing a computerized system validation approach and assuring the compliance of the processes and systems with GxP and IT standards.
* Anticipating early on that the Computerised System Validation requirements and pre-requisites are embedded into the overall programme management methodologies.
* Assuring that programme governance and processes support Computerised System Validation standards.
* Understanding the range of the business and IT requirements, risks, and change impacts associated with fit-to-standard and global process harmonisations.
* Having a strong partnership with senior stakeholders within the business and IT is important to success in this role.
* Liaising with the programme teams and local organizations to ensure compliance is assured for both the global design and localizations.
* Manage Computerised System Validation deliverables acting as AXIAL Project Quality Manager.
o Creation of key Qualification/Validation documentation.
o Enforce Computerised System Validation procedures and processes by reviewing and approving project documentation and deliverables such as Specifications, Plans, Reports, etc.
o Support the creation of Risk Assessment.
o Provide oversight of Testing Plans and Reports.
o Ensure completeness and traceability of requirements to testing.
o Ensure Computerised System Validation best practices are embedded across teams.
o Foster Good Documentation Practices aligned with ALCOA+ principles.
o Ensure corporate SOP and supporting templates are used.
o Advising compliance topics and supporting key decisions related to all regulatory needs (GxP; GDPR; Legal; Data Integrity; Internal Controls, IT Security Controls; etc.) o Maintain tools aligned to ways of working, e.
., Solution Manager, Jira, etc.
o Ensure compliance activities and deliverables are completed as planned.
o Ensure exceptions and deviations are documented and approved.
o Provide Computerised System Validation awareness and training.
o Coordination of and reporting on CSV activities for the SAP S/4HANA implementation.
Essential Skills/Experience * Deep knowledge and experience of Computerized System Validation.
GxP, ALCOA+ and SOx * Degree and significant experience in life sciences/pharmaceuticals industry.
* Demonstrated experience in complex projects and programs.
* Experience of Operations either on business or IT side, ideally in Manufacturing, Quality Management, and Supply Chain Management * Fluent English * Highly-analytical with strong attention to detail.
* Excellent communication skills and facilitation skills.
* Experience in global cross-functional and multi-cultural companies.
* Proven track record in navigating complex stakeholder groups.
* A collaborative style and ability to operate successfully in a matrix environment.
Desirable Skills/Experience * Previous experience with SAP, validation, and quality management.
* Good knowledge of Information security, Data privacy, Financial controls.
* Experience with Jira, Solution manager, and testing tool.
* Auditing experience is a plus.
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.
In our dynamic environment, be supported by the brightest minds working together side by side.
Agile and collaborative, we work cross-functionally to succeed together.
This is a place of great passion and pride.
Where we work hard to build successful, inclusive, and diverse teams that collaborate across the enterprise and beyond.
Always striving for better, where new ideas are encouraged, and failure is an anticipated part of our innovation process.
Bring out the best in yourself and others.
Be open to - and seek out - different thinking to cross-pollinate ideas and approaches.
Develop how you work in new ways with partners and collaborators, determined to create an inclusive and equitable environment where people belong.
Our culture of recognition and reward means we feel supported and empowered to take the initiative and take responsibility.
With all the tools you need to succeed, including constructive coaching, there's no better place to take ownership of your career and be your best.
Ready to make a difference? Apply now! Date Posted29-nov.- Closing Date12-dez.- (COMPANY NAME) embraces diversity and equality of opportunity.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be.
We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.
We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements