Jazz Pharmaceuticals

  • Quality and Compliance Manager, Italy

    Job Post Information* : Posted Date 1 month ago(10/17/2018 9:07 AM)
    ID
    2018-3903
    # of Openings
    1
    Min. Exp. (Yrs)
    7
    Category
    Commercial - EU/RoW
    Advertised Location : Location
    IT-Remote Office Non Sales International
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Remote Office Non Sales International
    Advertised Location : Postal Code
    00187
  • Overview

    Jazz Pharmaceuticals è un’azienda biofarmaceutica internazionale impegnata a migliorare la vita dei pazienti attraverso l’identificazione, lo sviluppo e la commercializzazione di prodotti significativi, volti a rispondere a bisogni medicali non soddisfatti. Continuiamo ad ampliare il nostro portafoglio di prodotti commerciali e la nostra pipeline di ricerca e sviluppo in aree terapeutiche che possano beneficiare della nostra straordinaria esperienza.


    Le aree terapeutiche di nostro interesse riguardano i disturbi del sonno e il settore ematologico/oncologico, dove abbiamo una conoscenza approfondita del percorso del paziente e disponiamo di una gamma di prodotti e potenziali prodotti rispondenti a bisogni critici.


    Siamo alla ricerca del talento più qualificato e brillante da inserire nel nostro team. Se siete interessati a far parte di un’azienda fermamente impegnata a migliorare la vita dei pazienti e ad essere un posto di lavoro eccellente, vi invitiamo ad esplorare le nostre offerte di lavoro ed a conoscere Jazz Pharmaceuticals.

    Position Profile

    The Quality and Compliance Manager supports the Affiliate in all the activities related to quality, processes governance, internal policies and procedures (excluding the ones in charge of EU/ROW Compliance dept) addressing high quality standards at Affiliate level. Working closely with the local Management Team and with other key process owners in the Country, he/she is responsible for advising on the potential risks of any activity ruled by the local legislation or any company policies.

    The incumbent is also the link between the Affiliate and Quality, Privacy and Compliance EU/ROW functions, taking care of and supporting the implementation and training on SOPs. The function supports as well the Quality and Compliance Officers during auditing processes at Affiliate level on any policy and procedure, and the relative implementation of corrective actions.

    The incumbent has responsibility for ensuring all activities are executed in accordance with regulatory and legal frameworks including but not limited to local compliance legislation and guidelines,  EFPIA, GCP and IFPMA regulations as well as Jazz Pharmaceuticals Policies and Healthcare compliance procedures.

    Essential Functions

    Quality – including oversight and support to GxP related affiliate activitiesDevelop Local Quality Management Systems consistent with in-country requirements and JAZZ QMS.

    Lead and coordinates Quality Management Reviews for Italy

    Lead local implementation and alignment of Global Quality Management Systems (Global Directives).

    Act as functional learning liaison (FLL) ensuring the assignment of Core Quality training and management local training assignments

    Oversee the documentation management system for local procedures (GxP and non-GxP) performing the role of Quality Unit to the GxP related documents not owned by the Quality Assurance function.  

    b)  Responsible for oversight of activities relating to Good Distribution Practices:

    Keep up to date on cGDP and regulatory requirements and ensures that JAZZ products are distributed in accordance with their licenses and with applicable regulatory requirements. Ensure that suppliers and customers are approved in coordination with responsible departments. Approve any subcontracted activities which may impact on GDP.

    c)  GDP-related Audits and Inspections:

    Support local health authority Inspections with readiness, preparation & coordination. Host Affiliate Audits and coordinates, performs related follow up and CAPA implementation. Lead and coordinates self-inspection program.    Provide oversight of vendor management (affiliate external partners who perform GxP activities) including quality agreements

    d)  Product related issues:

    Ensure that suspected counterfeit product is immediately notified for investigation and coordinates local management as per JAZZ procedures. Cooperate with all necessary departments to ensure that communication to the authorities is appropriate, coordinated and approved.

    Responsible for the certification processes (Farmidustria, ISO 9001) and related activities including internal audits execution, document system maintenance and trainings.

    Active member of Grants & Donations Review Committee, Review Committee and Coordinator and member of Affiliate Governance Committee; Congresses’ review team member.

    Act as Italian Compliance Officer by executing the quarterly monitoring activities as per annual plan (e.g., payments to HCPs, grants, sponsorships, marketing activities), including assisting with local language translation. Act as country champion and assist the local roll-out of corporate tools supporting Compliance processes. Responsible for executing and maintain law 231 model, interacting with “Organismo di vigilanza” as described into the law.

    Assist in setting-up and maintaining registers of data processing activities

          Support in training local employees on data privacy awareness and new data privacy policies. Provide guidance to colleagues on answering data subject rights requests, data incidents and other ad-hoc privacy matters and facilitating notification to GPO as appropriate. Liaise with International Function on data privacy local requirements.

    Internal member of the Vigilance Committee, in accordance to 231 Decree. Coordinator of routine meetings and minutes recorder; Coordinate Model revision, training materials and ensure proper training assignments. Coordinates quarterly reporting by all company functions.

    Responsible for Health and Safety at Affiliate level. Liaise with HS external vendor and supervise its activities. Liaise with Corporate security on corporate security program matters.

    Support the Affiliate in implementation of appropriate systems and controls to ensure compliance with applicable local, regional and global transparency requirements and support the global transparency program as requested and as follows:

    Provide detailed understanding of local processes and systems related to Affiliate specific transactions

    Support Affiliate functions regarding the implementation of payment disclosure systems in relation to applicable global, regional and local requirements

    Provide transactional level understanding of local operations

    Local project coordinator/lead to help identify Affiliate resources with the specific transactional and operational knowledge

    Tracking and managing affiliate response to project requirements

    Reporting to management, CO and global teams on local project status

    Support local reporting, documentation and aggregation of information

    Required Knowledge, Skills, and Abilities

    • Previous experience of pharmaceutical compliance and quality in a corporate setting
    • Previous experience of conducting quality / compliance audits, ideally in a corporate pharmaceutical environment
    • Deep knowledge of business and market dynamics
    • Strong knowledge of the local legislation in the pharma market as well as of SOPs, policies and procedures
    • Able to understand and optimize internal processes
    • Technical competences on quality, compliance and governance linked to Italian market and organization
    • Flexibility
    • Conflict management
    • Problem solving
    • Cross functional working
    • Excellent command of English

    Required/Preferred Education and Licenses

    • Bachelor Degree (ideally in Economics or Law)

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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