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Job Purpose:
The current approved GSK vaccine portfolio includes around fifty different products. The product portfolio needs continuous process and product maintenance to always keep the products in a compliant state and keep continuous improvements of the manufacturing process and analytical methods.
The product Implementation Committee’s (IC's) ensure supply continuity of Vaccines Product. The team is responsible, based on the level of the regulatory submission, for:
1. Tracking the monitoring of all the Change Controls, in the approved CMC envelope, with Tell & Do impact and/or with supply impact until interim/final closure
2. Providing GO/NO GO Market implementation decision (before the implementation into manufacturing operations or QC laboratories and first supply to markets)
3. Monitoring the CMC Envelope starting from its final endorsement by PSLT and all along its cycle.
•The Implementation Committee Manager is responsible to facilitate and lead the Implementation Committee for the vaccines under her/his responsibility, managingGlobal cross functional teams.
•Ensures continuous exchange of knowledge and close collaboration with molecular stewards and master data team in global MSAT as well as GRA and Global Supply.
Key Responsibilities:
•The Implementation Committee Manager has the following key responsibilities:
•To facilitate and lead the Implementation Committee for the products under her/his responsibility managing global cross functional teams based in different geographic areas.
•The IC manager must check the definition and follow up of the market implementation strategies of changes having a regulatory impact (i.e. Tell & Do changes), to ensure geographic expansion, supply continuity in the market in all countries, keeping alignment with the Product Life Cycle Management plan priorities owned by PSLT and CMC product envelopes.
•Facilitate and record decision of product IC teams on GO/No GO decisions for market implementation, in alignment with supply needs and risks raised by IC stakeholders
•Monitoring the CMC envelope starting from its final endorsement by PSLT and all along its cycle.
•Ensuring appropriate communication of issues or risks to the ad hoc governance meetings/boards and look for or confirm mitigation plans
Knowledge/ Education / Experience Required:
•Advanced degree in process engineering sciences, and/or academic level in life sciences in general (biology, biomedical science, pharmacist, chemistry, chemical engineering).
•Minimum 10 years applicable experience in biopharmaceutical manufacturing and / or experience in QA, QC, R&D within a biological environment
•Proven experience in project management
•Excellent understanding of the framework within which a pharmaceutical product has to be maintained in compliance: Authorities / Scientific / Business
•Good understanding of change control process
•Good understanding of production & QC master data
•Understanding of regulatory level in main regions (US/EU) and of supply chain mechanisms
•Comfortable with IT tools needed for the job (e.g., Excel, VeeVa Suppliable Table, , SAP)
Other Job-Related Skills:
•Proven Track record in problem solving and global project management.
•Good skills in project management, change management and team/meeting facilitation.
•Ability to plan, manage and lead cross-functional teams (matrix leadership) and projects to obtain desired business objectives.
•Good interpersonal communication and negotiation skills
•Cross cultural experience and proven ability to work in a complex and multi-cultural environment.
•Proven ability to communicate and negotiate effectively with different levels of management across functional, national, and cultural boundaries.
•Proven ability of understanding compliance requirements
#LI-GSK
Skills
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
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Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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