Viral Safety Senior Manager
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Mar 9 2023
Viral Safety Senior Manager:
Do you want to make a difference? Are you energised by global quality and close partnership and collaboration with key stakeholders, bringing the quality mindset? If so, this opportunity to join a diverse team of experts could be the perfect fit for your career.
Viral Safety Senior Manager.
This role is part of the Viral Safety Centre of Excellence in the Global Quality, whose mission is to drive existing and new Viral Safety activities with local SMEs and product experts, ensuring alignment with Quality and Regulatory standards and Business priorities.
Your responsibilities:
Key Responsibilities include, but are not limited to:
Technical Expertise:
- Develop knowledge and build competency across the network
- Utilize stateoftheart knowledge and technologies to control and anticipate viral risks, identify and drive innovations which are ambitious for patient safety and product quality
- Ensure transversal alignment among all stakeholders across GSK involved in the viral safety management
- Establish and update response plans in case of contamination
- Plan, organize and manage simulations of contamination events
Quality management:
- Lead development, implementation and maintenance of the appropriate quality standards for Viral Safety transversal processes, i.e., selfinspection, documentation and quality management
- Support local sites and product experts regarding Quality system requests
- Coordinates management of local and global CAPAs with task owners
- Support inspection readiness in local sites. Ensure harmonization of messages. Provide appropriate documentation and communication packs
- Drive crosscontamination control strategy in collaboration with GIO/Q business units
Process ownership:
- Manage Viral Safety risks, coordinates the accomplishment of tasks that are under the responsibility of local SMEs and product experts
- Interact with product experts to assess the impact of a change on Viral Safety. Interface between product experts and Viral Safety Steering Committee. Establish an action plan with involved stakeholders when process changes required any mitigation to control new risks
- Update risk description and response, revise and adapt risk scoring considering local assessments and global harmonization
- Ensure appropriate control and monitoring of viral risks through Risk Management Boards
Network Interaction:
- Establish crossdepartmental partnership between Viral Safety team and internal stakeholders (MSAT, TRD, QCs, Regulatory affairs, GIO, QA) to develop consensual scientific and technical perspectives for analytical and process strategies aimed to manage the viral risk in vaccines
- Develop and lead Viral Safety Communication Plan and ensure consistent and effective communication to all stakeholders
- Inform internal key stakeholders with scientifically consolidated messages in order to facilitate discussion and secure decisionmaking process
- Develop and maintain strong relationships within assigned analytical and product areas with other stakeholders including MSAT, R&D, QCs and Regulatory Affairs to better understand and fully support business objectives
- Provide local and transversal leadership to ensure the execution of the tasks resulting of the viral risk assessment and to globally answer to the needs of the organization
- Interact with other Viral Safety entities in the entire GSK organization to develop best practices in term of knowledge management, risk assessment methodologies, risk control strategies and external advocacy
- Key contributor to developing the Viral Safety Centre of Excellence
External advocacy:
- Leverage scientific skills and capabilities to influence and shape the regulatory landscape
- Monitor and assess new developments, industry trends, evolving regulatory expectations
Why you?
_ Basic Qualifications:
_
- We are looking for professionals with these required skills to achieve our goals:_
- University degree in life sciences (biological, veterinary, pharmaceutical)
- At least 10 years of experience in an industrial environment, preferably in pharmaceutical industry
- Quality mindset with good knowledge of pharmaceutical operations (including manufacturing and testing of vaccines) and quality systems
- Strong influencing skills at all levels of the organization, and proven ability to manage networks
- Customer focused with the ability to develop and execute programs, through crossdepartmental partnerships
- Excellence in effective/transparent/honest communication and presentations for a wide variety of audiences, strong influencing and negotiation skills
_ Preferred Qualifications and experience:
_
- If you have the following characteristics it would be a plus:_
- Teamplayer with ability to work with crossfunctional teams and communicate effectively
- Participative leader
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