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Performance and Customer Center of excellence Quality Lead and Responsible Person
il y a 1 semaine
This position reports to the Performance and Customer Center of Excellence Global Quality Leader.
The Supply Chain & Logistic QO (SCLQO) Leader will be the appointed Responsible Person (RP) for Good Distribution Practices (GDP) of Zoetis Belgium (Zaventem).
The SCLQO Leader will have overall responsibility to assure quality objectives are met by the external Logistics Services Provider (LSP) and to provide internal quality consulting to Zoetis Supply Chain & Logistic (SCL - Logistics, Intercompany, Transport and Customer Service) and Commercial leaders at the site and within the EuAFME Region as required. The SCLQO Leader will have direct reports and will serve as a partner alongside other stakeholders in the EuAFME region to enable business objectives by meeting quality objectives.
The SCLQO Leader will oversee the risk-based approach to managing quality aspects of external partners that include logistics service provider and transport companies. The SCLQO leader will work closely with SCL and Global External Supply (GES) organizations to coordinate business activities, communicate priorities, drive problem to resolution and proactively work to maintain product supply.
The role is responsible for the Supply Quality interface with Supply Chain and Logistic Operations, Regulatory and Commercial Organizations providing guidance on Quality and Compliance aspects for Supply.
The SCLQO Leader will develop longer term Quality Strategy objectives and Quality Roadmap to keep the site compliant with applicable quality regulations, maintain agility, and ensure effectiveness across the Business. The SCLQO Leader will establish/maintain appropriate processes and metrics and enhance problem solving at site level of the SCL quality organization.
Organizational Quality Responsibilities
Serving as a quality culture role model and promoting a strong Quality & Compliance culture that translates into a Right- First-Time mindset and insures the effectiveness of the Quality Management System. Ensuring Quality System Standards and Processes are appropriate and up to date for the SCL and SCLQO organizations. Develop long-term Quality strategy for the site. Organizational Goals translated and adapted to SCL Quality goals. Creation and Management of the site Quality Roadmap and Quality Risk Register.SCL Quality Functional and Process Responsibilities
Be the Responsible Person for Distribution per Belgian legislation and ensure compliance to GDP including a fully implemented and maintained Quality Management System.Within the scope of distribution are the local distribution (e.g. Belgian market), the transportation, import, export and storage activities managed by or in behalf of the Principal Company, including oversight of contracted LSP.Authorize the return to saleable stock of any returned medicinesEnsure that relevant customer complaints are handled efficientlyDevelop and maintain the appropriate Risk Management Process and mechanisms for managing Contract Service Providers including qualification, approval and Quality Agreements. Ensure adequate Quality oversight is provided for the LSP, Relabelling and Transporter CompaniesEnsure that self inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in placeCollaborate in the coordination and completion of any recall operations, following Global and local guidelines and proceduresBe involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products Review and provide input on the draft Quality Standards and Global Procedures to ensure they meet the GDP requirements. Develop local procedures when needed. Ensure Products are timely available by managing key processes that include product release; relabeling; temperature monitoring/excursions; master data (SAP); and licenses Development, management and reporting of the site SCL Quality Process Goals and Metrics. Establish and lead the site Quality Governance Council to inform management about product quality and process performance, quality risks, compliance with internal and external requirements Assist SCL in Supply Flexibility and maintain compliance / adherence to Zoetis Standards (especially for market launches; transfers; change control; and late labeling if applicable). Establish strong working relationships with SCL, regulatory and commercial personnel. Work as a Quality Partner with SCL, regulatory and commercial to advise / train on key Quality Standards and Processes. Assuring the use of operational excellences tools in quality processes Be the primary contact and oversee quality- compliance of Feed according to relevant Belgian/EU regulation:Maintain HACCP system required by European lawWork with regulatory for assessing risks, i.e. monitoring testing for absence of residuals or contaminantsManage any inspection by the Food Chain Security Agency (AFSCA/FAVV)Coordinate the external audit for the FCA certificate (per OVOCOM standards)Staff and Leadership
Leadership Development / Coaching of Staff; Creation of Learning Organization Ensure Training and Development plans are in place for the Quality colleagues and other colleagues engaged in products distribution Manage Quality operations budget and resources planning for Zoetis Beligum Driving the Quality Culture Change and Quality Enhancement Program for Zoetis BelgiumEducation:
Master degree in Pharmaceutical Science (preferred), Veterinary medecine, Chemistry, Biology or equivalent to be accepted by the Belgian authorities as Responsible Person for GDP per Belgian RD of 14 december 2006 art 222;Experience:
Proven Quality Management experience (7+ years) in Animal Health/Human Health pharmaceutical environment. Knowledge of current Good Distribution Practices (GDP) and EU pharmaceutical legislation and regulations. A good understanding of Feed regulation is an asset. Ability to understand and communicate with a wide range of external business models/entities Problem solving in a volatile environment. Six Sigma Black Belt / Green Belt certification is an asset. Previous Leadership experience including management of external contracted entities Working knowledge of pharmaceutical product transportation channels and LSPs Experience in working with Belgian / EU regulations and Authorities.Technical Skills Requirements
People Management / Demonstrated Leadership Skills Demonstrated success in a Quality Operations Role Firm understanding of Quality Management Systems Sets Clear Direction and Aligns Team and Others Around Common Objectives Ability to communicate and influence broadly – especially with external entities Ability to analyze data and synthesize to make data driven decisions Ability to Develop and Implement Strategic Initiatives Process Owner Management Continuous Improvement and break-thru thinking Fluent in EnglishLocation:
Zaventem, Belgium. This position will require fluent use of teleconferencing tools, as well as Sharepoint technologies, to share and manage information with global locations and manufacturing sitesTravel: Estimated 10% travel
Full time