QC Project Manager - 1 year contract

The incumbent is responsible for the management of analytical activities related to lifecycle and projects on vaccines and intermediates, bringing the analytical expertise to multi-disciplinary technical teams and assure operational activities linked to change in analytical strategies to support their right application in commercial phase.

He/she is accountable for establishing stability protocols and reports as well as the stability sections of the product quality review, for managing deviations, CAPA’s, change controls and projects integrating analytical aspects, technical and regulatory impacts as well as supply demands.

• Create or modify the vaccines monographs and stability plans according to established control strategy
• Be accountable for performing the adequate statistical trending of stability results in order to confirm shelf-life and specifications
• Bring the Be QC voice and analytical expertise to multi-disciplinary Technical teams (PTLT, Task force, project working group...)
• Be responsible for Identifying technical and supply risks, timing and resources constraints and seek a remediation plan for identified risks. Escalade any analytical technical and/or supply issues to the relevant body (PTLT, QC escalation meeting, supply council…)
• Act as QC Single Point of Contact for lifecycle product improvement projects in line with Global supply chain objectives. This includes the coordination of the alignment of QC labs deliverables in terms of quality, time and cost as well as discussing the QC resources allocation and development activities to achieve the target with the laboratory heads.
• Collect & Challenge various testing demands and their planning (QC planning and prioritization tool).
• Be responsible for the timely writing of the stability sections of the annual Product Quality Review. Participate in the CPV process as per procedurized responsibilities and coordinate the implementation of identified improvements (CAPA) for the products under his/her responsibility.
• Execute, coordinate or approve the QC tasks in the frame of Change controls identified within Technical Teams.
• Ad hoc coordinate delivery of QC source documents related to RA files registration, variations and Question and Answer. Is accountable for providing the intermediate and final QA approved stability reports within the timelines agreed with RA in the frame of variations and commitments.
• Manage deviations associated to scope of responsibilities. Ensure that all the technical activities related to the investigation of significant analytical and quality issues are conducted to guarantee the continuity of supply and are in accordance with the current regulations.
• Act as key player during Regulatory inspection and meetings. Present and defend operational aspects linked to analytical and stability strategies for the products under his/her responsibility, during GMP inspections (FDA, EMA, other national authorities, GSK corporate…)
• Create network with global function (GMSAT, GQC, GQA)

• Master in chemistry, biology, bioengineering or pharmacy (phd preferred)
• 5 to 10 years in the Pharmaceutical industry with significant experience Quality Control, analytical development, regulatory, R&D and/or lifecycle management in the fields of biologics, vaccines and/or biopharmaceuticals 
• Minimum of 5 years’ experience in Quality with increasing responsibility (transversal function) and demonstrate Leadership skills.
• Deep Knowledge of Vaccine testing and manufacturing environment
• Excellent understanding of the framework within which a pharmaceutical product has to be developed and maintained in compliance with specifications and regulatory requirements. Demonstrated knowledge of CMC or cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems Experience with licensing and product release standards for the US, EU, and other primary regulatory regions.
• Ability to engage, influence and lead people
• Project management skills
• Ability to work autonomously and effectively in a highly matrixes organization across geographies and cultures
• Ability to obtain information and identify key issues and relationships relevant to a long-range quality goal or vision; committing to a course of action to accomplish a long-range goal or vision after developing alternatives
• Demonstrated knowledge of regulated environment of pharma / biopharma / vaccines industry.
• Ability to communicate complex information both orally and in writing.  Ability to listen effectively.
• Ability to drive change
• Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
• Technical competency to evaluate investigations, product issues, etc.  Incumbent does not need to be a subject matter expert, but must have the ability to ask questions that lead to the discovery of root causes
• Ability to understand statistical tools
• Spoken & written English (communication, negotiation, facilitating, influencing)

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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.

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.

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