You will be taken to GSK GCC Bangalore’s own careers page to apply. Job ID Job Code: J000410.
Job description
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 Implementation Committee Manager
Is responsible to facilitate and lead the Implementation Committee for the vaccines under her/his responsibility, managing 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.
Ensures a consolidated view of Transversal project/program priorities (GVSC, MSAT, …) and oversees their progress (applicable to Vaccine Transversal Project Forum only)
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. (Experience between 10-13 years)
She/he must guarantee 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.
Where necessary, support business to Identify/leverage opportunities to propose innovative implementation strategies, aligned with supply constraints and/or risks identified (highlighted during Technical Lifecycle meetings, escalated at PSLT level, or any other appropriate governing body).
If necessary, put in place/animate and lead dedicated implementation committee for complex projects which may involve multiple sites and/or variations (e.g.,), or for upcoming variation which requires accelerated implementation (e.g., drift of reference vaccine, batch release blocked by QC OOS, invalid recurrence, etc.)
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
Gather a consolidated view of the Transversal projects'/programs' priorities (GSC, MSAT, Strategy PM …) translated into a consolidated roadmap, including risk assessment on any potential risk on key milestones which may affect the implementation (applicable to Vaccine Transversal Project Forum only).
Educational Background
Minimum Level of Education - Advanced degree in process engineering sciences, and/or academic level in life sciences in general (biology, biomedical science, pharmacist, chemistry, chemical engineering).
Key Skills
Proven Track record in problem solving and global project management.
Good skills in project management, change management and team/meeting facilitation.
Ability to manage critical complex multi projects affecting the post approval projects to ensure compliance
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
Ability to understand content (from business standpoint) of change controls
Ability to manage data analysis and IT tools
In addition, demonstrated competency in the following areas is required:
Analytical, influencing, negotiation and problem-solving skills.
Business integration capabilities to translate internal and external best practices.
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: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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