Director Q 4.0 Operational Lead, Open to flexible working
- Contract Type
Are you energized by a highly visible role that allows you to define and implement Q4.0 for Vaccines and lead the Quality Oversight Operationalization of our major projects (MES, Veeva QD, Veeva QMS, etc.), if so this Director Q 4.0 Operational Lead might be the right fit for you!
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following;
- Responsible for Quality Oversight of operationalization of Q 4.0 projects such as MES, Veeva QD, Veeva QM
- Ensure that new systems will achieve by design quality performance targets, regulatory compliance
- Act as key partners and advisors of VP ops for the deployment of the GSK Vaccines Q 4.0 strategy within Manufacturing facilities ensuring a transversal alignment across MPU (site) entities
- Responsible for approval of operational functionalities/features of all Q 4.0 projects
- Responsible for approval and enforcement of common works of working and processes related to transversal systems (MES, Veeva QD, Veeva QMS)
- Responsible for the change control for of all Q 4.0 initiatives
- Contribute to the overall ambition of Vx to simplify our processes while keeping highest level of compliance.
Strategy and Direction:
- Lead the reflexion and build harmonize quality processes impacted by digitalization such as, eBR content, approbation flow, review by exception
- Operate as Quality responsible person for approbation of new processes and ways of working for new systems being deployed across the organization
- Provide leadership on digitalization of QA review such review by exception
- Ensure alignment of respective digitalization initiatives with the strategy, objectives and policies of Vx Quality assurance and quality systems.
Operations and Quality :
- Be the quality partner and decision maker for projects such as: MES, Veeva QD and Veeva QMS, as well as for documentation simplification initiative
- Be proactive in anticipating potential improvements of the current quality processes while assuring compliance with the Change Management Procedures
- Work collaboratively with the GSME, GBO and specific project groups to realize synergies, deliver best Quality practice and consistency/harmonization of approach
- Develop improvement plans to ensure ongoing compliance with future requirements.
- Responsible for representation of digitalization activities during external audits (FDA, WHO, National Health Authorities).
Change and Process Management:
- Provide leadership for change initiatives involving processes, technologies and people which contribute to the overall effective improvement of GSK Vaccines Quality.
- Educated to degree level (technology, biological science, or other health related discipline), advanced level degree preferred
- Master's degree in a science, technology, quality or industry related discipline
- 10+ years of experience in the pharmaceutical/biopharmaceutical industry, including 5+ years of experience in a Quality role with increasing levels of responsibility
- Substantial knowledge of regulatory, GMP, sterile manufacturing and legal requirements relating to QA
- Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
- Ability to manage complex projects, situations and effectively communicate
- Ability to streamline and revise processes to build in efficiencies
- Strong analytical skills with practical knowledge of how to identify key performance quality metrics to set targets
- Developed knowledge of data integrity
- Excellent technical skills and knowledge of relevant national / international regulations
- Organizational, verbal and written communication skills
- Ability to build and leverage relationships with a culturally diverse groups
- Ability to work flexibly and adjust to changing priorities
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
- Excellent English and French spoken and written skills
- Computer proficiency
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.
GSK Vaccines - Our Vaccines business is one of the largest in the world, developing, producing and distributing over 2.5 million vaccines every day to people across 170 countries.
Global Quality Departments 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.
Quality Belgium manages all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. Quality Belgium is also responsible for the quality control and the release of final products made in Belgium.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
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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