Servier
Postée il y a 3 jours
Servier est un Groupe pharmaceutique international qui aspire à avoir un impact sociétal significatif pour les patients et pour un monde durable. Les 21 800 collaborateurs qui le composent sont engagés autour d'une vocation commune: être engagé pour le progrès thérapeutique au bénéfice des patients.
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We are a human-scale, international and independent pharmaceutical group, governed by a Foundation. We are proud of our unique business model, but above all, IT enables us to fully serve our mission : committed to therapeutic progress for the benefit of patients. Today's world leader in cardiology, we have chosen to become a focused and innovative player in oncology by 2030, by targeting hard-to-treat cancers and devoting over 70% of our R&D budget to them. This is a challenge we are pursuing in parallel with the development of our generics business, to ensure access to quality care for all, at the lowest possible cost.
We are 21,900 passionate people of over 50 nationalities, driven by an entrepreneurial spirit. Every day, we move forward with and for patients, with and for our teams, driven by the desire to care, to dare, to develop, to commit ourselves to being useful to those who need IT.
Come live and contribute to our commitment #MovedByYou
https://servier.com/groupe/
www.servier.com
Reporting to the Group Head of Global Quality, you will BE in charge of :
Ensure Commercial operation Quality organisation, quality systems & processes are in place to best support the overall Group 2030 ambition.
Build and lead a consistent Quality culture within the Commercial Operations and drive quality initiatives worldwide, providing a contact point for quality matters.
Design, implement and maintain the Commercial Operations' Quality Management System (QMS) to ensure compliance with GxP regulations, local requirements, and the Group Quality management system.
As a key member of the Global Quality leadership team, collaborate across functions to foster operational excellence, continuous improvement and cost-consciousness while maintaining the highest quality standards.
Ensure adequate preparation for local regulatory inspections and manage follow-ups.
In collaboration with Global Quality team, support the Affiliates, Representative Offices, and Promotion/distribution partners to adequately handle quality issues and to provide appropriate governance on quality matters.
Define, monitor Key Quality metrics, and identify & drive continuous improvement action plans.
Define, optimise, and control financial budget within his/her remit
Main responsibilities :
Deploy a harmonized QMS across Commercial Operations groups efficiently :
Define & implement common global quality policies, procedures, and best practices across all Commercial Operations in collaboration with other functions having GxP related activities.
Contribute to the definition of Servier QMS and related documents (e.g. e-quality systems URS), acting as Subject Matter Expert and Business Representative.
Define the quality roadmap for the deployment and/or consolidation of QMS elements within Commercial Operations and drive accordingly.
Support Affiliates, Representative Offices with local QMS deployment.
Strengthen the risk management culture and support the maintenance of the Commercial operations Quality risk register.
Ensure comprehensive training program covering all GxP activities is in place and support training initiatives as needed.
Drive the visibility of the quality compliance & performance of Commercial operations units by implementing appropriate Quality metrics and Quality Management Reviews.
Coordinate the Quality regulatory watch within Commercial operation units.
Ensure GxP & regulatory compliance :
Support inspection and audit management at Commercial operations units (i.e. inspection readiness program & CAPAs definition/completion).
Drive remediation plans when a product quality or GxP process issue is identified.
Focus on proactive crisis prevention and support the Group Quality alert process (Servier Quality Alert Committee) and CAPA follow-up when needed.
Facilitate troubleshooting (e.g. significant complaints, QTA negotiation) and ensure appropriate CAPAs are written and completed on time.
Ensure appropriate intracompany Pharmaceutical Responsibilities Quality & Technical Agreements (QTAs) between Head office (Servier LLS) and local commercial units are put in place.
Drive & support local initiatives on continuous quality improvement.
Foster the Quality culture :
Drive a Quality beyond compliance culture throughout the commercial organization, encourage best practices sharing and continuous improvement.
Maintain structured customers/stakeholders' communication between local Servier' Commercial units and the corporate ones to improve integration and common understanding.
Manage cross-functional teams to streamline processes and ensure effective resource allocation.
Commercial Operations & Quality Strategy :
Develop and execute a comprehensive quality strategy aligned with the Group's 2030 ambition and goals.
Represent the voice of Commercial Operation Quality in strategic projects such as (non-exhaustive list) : Geographical footprint review, new asset/company acquisition (Due diligences & integrations) & Commercial Products launches.
Lead and drive the Quality management of promotion/distribution partners.
Ensure alignment of Quality projects initiated between head office and local commercial units.
Ensure a proper execution of the project management methodology in its area of oversight to ensure excellence in execution.
Act as a Sponsor for identified Global Quality strategic initiatives.
Stakeholders' engagement :
Collaborate with senior leadership at commercial operations to align quality and operational strategies with overall business objectives.
Communicate quality issues and progress to stakeholders effectively.
Act as an ambassador for the group Quality culture.
Engage with external partners, suppliers, and customers to ensure quality standards are met.
Collaborate with peers across the Group to promote quality initiatives/practices and adopt best practices identified from other departments such as : Global Manufacturing, Global Medical & Patients Affairs, R&Detc.
When needed, work cooperatively with other entities & functions to ensure that quality is appropriately embedded on a regular basis.
Leadership :
Build and lead a high-performing quality and operations team, fostering a culture of accountability and continuous improvement.
Provide mentorship and professional development opportunities for Commercial operations Quality representatives and develop a talent pipeline to ensure business continuity and employees development.
Promote a collaborative environment, ensuring clear communication and coordination between the Global Quality teams, Commercial operations, and other departments.
Ability to align stakeholders behind the Group interest promoting standardization & harmonization of Servier Quality way of working.
Define, communicate, and implement the organization, the objectives, and priorities on his/her perimeter.
Profile required :
- Life sciences Master degree (pharmacy, chemistry, microbiology) or MD.
- An experience as QP of a distribution affiliate in a pharma company is a plus.
- A black belt certification (6 Sigma) is a plus.
- Minimum 15 years' experience in international pharmaceutical quality management in various GxP areas as well as interfacing with Executive Committee.
- At least 10 years of leadership experience in international, matrixed organizations.
- Fluent in English (both oral and written); proficiency in additional languages is a plus.
Hard Skills :
In depth knowledge in various Pharmaceutical regulatory. Experience of working in a matrix organization. Multicultural and global Team management experience.
Successful product portfolio experience. Including new asset/company acquisition & integration, geographical expansion & Promotion/distribution partner management.
Experience of leading successfully major regulatory inspections (FDA, EMA, PMDAetc.).
Excellent analytical and problem-solving skills.
Strong business acumen, exhibiting a strong knowledge of financial numbers and how value is driven in the business, taking actions that drive up the financial value of the business while maintaining a patient centric approach.
Leadership Skills :
Ethical leadership, putting patient interest first in all decisions made.
Strong leadership skills, with the ability to inspire and guide teams towards achieving strategic goals.
Proactive leadership anticipating industry trends, such as emerging Quality standards, Digital tools & approaches, or advanced technologies.
Excellent understanding of performance management. Proficient in utilizing a variety of reporting and analytics tools to gather, analyze, and interpret data, enabling informed decision-making and strategic insights.
Ability to understand the big picture and steer a large team behind the collective benefit, always putting patients' interest first.
Ability to make effective decisions with appropriate rational based on data & science, balancing risk, and compliance.
Soft Skills :
Strategic thinking and anticipation, ability to find innovative solutions to complex problems.
Proven ability in stakeholder management, adept at engaging and aligning diverse groups to achieve common goals and drive successful project outcomes.
Demonstrated expertise in change management, effectively guiding organizations through transitions and ensuring smooth adoption of new processes and technologies.
Strong influencing skills and ability to present complex topics in simple way. Good verbal & written presentation skills.
Excellent communication skills, capable of engaging with various levels across the organization.
A modern quality thinker able to balance risks & compliance.
Act with respect and ethics.
We are committed to equal opportunities and the development of talent in all its diversity. We place as much value on experience as we do on the desire to commit oneself on a daily basis in order to contribute to therapeutic progress for the benefit of patients. If you recognize yourself in this offer and these few lines, take this opportunity to meet us.