Quality Operations Manager
Within the LIMS Deployment & User Support team (part of Clinical Laboratory Science department within R&D), the QO Manager is in charge of defining, implementing, maintaining and monitoring the Quality System.
• Key point of contact and reference expert for PL&O platforms for Quality & EHS matters.
• Communication & coordination:
o Initiate & coordinate regular meetings with QA representatives (e.g. on unplanned events, CAPAs...).
o Escalate Quality & EHS issues to platform heads& QO heads.
o Cascade information & decisions on quality & EHS matters to platform staff.
o Coordinate, in the platform, deviation & CAPA management, incl. FU of metrics & KPIs.
o Facilitate monitoring through tracking & communication of milestones completion.
o Coordinate risk escalation within the team.
• Manage PL&O platform specific SOPs:
o Write, revise, assign and retract platform transversal SOPs.
• Spotchecks, audits & inspections:
o Manage L1 quality & EHS spotchecks for internal.
o Prepare for audit readiness for L2, L3 and L4 audits.
• Organize logistics related to documentation à archiving.
o Coordinate EHS Risk assessment and document risks with team.
o Provide coaching to document the root cause analysis in case of accident.
o Ensure EHS actions are executed.
• Ensure promotion, training & assessment of 5S activities, when applicable.
• Actively participate to process simplification and improvement initiatives; and implementation of simplification/improvement action within the platform and transversely for the whole PL&O organization.
• Activities specific to LIMS Deployment & User Support team:
o Data integrity and risk expert within systems lifecycle and during projects.
o Lead the IT Incidents Committee and the Data Analysis Board.
o Take part to the Information System Review Team.
o Log, organize and follow the risks highlighted within LD&US team.
o Change control coordinator (initiate change controls in SAP, follow tasks completion with owners in due time...).
o Monitor team adherence to training matrix and highlight risk to miss the target.
o Ensure each process within LD&US is adequately documented.
o Guarantee process harmonization between the different teams of the LD&US group.
o Act as a coach / mentor on Unplanned Events / Deviations / CAPAs / Change Control / Written Standards / Data Integrity / ITMS and/or CVS methodology.
• Minimum 3 to 5 years' experience in regulated environment (GxP).
• Master's Degree.
• Proficiency in French and English are a MUST.
Significant experience in pharma industry (GxP environment).
• Deep knowledge of GCLP.
• Affinity with process improvement and optimization.
• Pronounced quality mindset.
• Excellent communication skills.
• Ability to manage time & priorities.
• Proactive, flexible and stress resistant.
• Results oriented.
• Ability to work collaboratively in a team environment as well as independently with no or little supervision.
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.
We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
Vaccines - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you require a reasonable adjustment to the application/selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require. This will help us to make suitable arrangements to support you throughout our selection process.
You may apply for this position online by selecting the Apply now button.
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