Job Purpose
Work with the GBPO to develop a strategy for the end-to-end process for PQR generation across medicines sites, vaccines sites, CMOs, LOCs and central functions.
Lead deployment of the new global PQR solutions in the supply chain.
Act as SME for MAH activities, ensure compliance and oversight of MAH activities for Trading Partner entities, ensuring compliance with relevant regulations, licenses and authority requirements.
Lead the MAH GCC team accountable for generating PQRs.
Key Responsibilities:
Team Leadership:
Manage the TPQ MAH/PQR GCC team accountable for generating PQRs.
Develop the capabilities within the GCC MAH/PQR team.
Ensure all job requirements are identified, documented and all training needs are defined in the training curricula of the team.
PQR & MAH Compliance:
Ensure the PQR process complies with all relevant regulatory requirements and industry standards. Monitor and interpret new compliance requirements, regulations, and guidelines relevant to PQR in the pharmaceutical industry, and their impact on MAH/PQR systems and processes.
Ensure compliance and oversight of MAH activities for Trading Partner entities and compliance with relevant regulations, licences and authority requirements.
PQR Process:
Manage the end-to-end PQR processes and develop business requirements documentation for deployment processes.
Ensure data and system requirements are defined and built to support the PQR process, deploying AI solutions where possible to improve efficiency.
Develop standard process and solutions for PQR, ensuring that deployment of those standard solutions are successfully integrated into the medicine and vaccine sites, LOCs, central teams and CMO processes.
PQR Build & Deploy:
Accountable for developing, communicating and deploying the global PQR process and standard template for the process, data and technical strategy with PQR users and key stakeholders.
Ensure the system design meets defined business requirements, deploying AI solutions where possible.
Work with the sites/LOCs/central teams/External Manufacturing to create a business change management/readiness plan for deployment which is in line with the new global PQR template.
Own a plan and schedule of work activities in accordance with the demand schedule timelines and ensure adherence to the plan to the required standard.
Generate and finalise PQRs, as required.
Identify issues and risks and escalate as required.
Support the PQR users as required.
Enable change in line with the PQR processes and collaborative learning between the sites, CMOs and markets as implementation progresses.
Conduct training sessions for relevant stakeholders to ensure understanding and effective execution of the PQR process.
Manage demand between medicine and vaccine sites, LOCs, central teams and CMO.
Embed & Grow:
Govern standards and drive continuous improvement.
Co-ordinate template changes.
Facilitate the Process for Communities of Practice.
Act as a PQR SME and support PQR users in the Supply Chain.
Knowledge/ Education / Experience Required:
Bachelor's degree in a relevant field (e.g., Pharmacy, Life Sciences, Quality Management).
Requires understanding and knowledge of the systems and processes in relation to PQR process in the supply chain.
GMP regulatory knowledge required related to PQR regulations in key markets e.g. EU, Canada, to provide detailed knowledge to support decisions being made relating to MAH.
Extensive relevant experience (>10 years) and total experience of 16+ years of pharmaceutical quality assurance/regulatory and distribution/manufacturing. Experience in a business process role in a complex global organization.
Leadership and people management and development.
A deep level of GxP, MAH and Regulatory Framework knowledge and problem identification and solving skills.
An understanding of data management and/or quality assurance processes.
An understanding of the systems development cycle, supporting documentation, change control and validation processes.
The ability to deal with stakeholders across the globe, dealing with varied professional and cultural backgrounds.
Excellent oral and written communication skills, in English.
Proven influence and impact skills across business levels and functions
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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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