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GROUP QUALITY CONTRACTS MANAGER(GQCM_072022)

Κωδικός Θέσης : GQCM_072022
Ημερομηνία ανάρτησης αγγελίας : 6/7/2022




FAMAR is a European contract manufacturing and development partner, for the pharmaceutical and health & beauty industry. Building on our 70 years’ expertise, we deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1850 employees and with a network of 6 production sites, we supply a wide range of 1800 products in 125 international markets.

We seek to recruit:


GROUP QUALITY CONTRACTS MANAGER (GQCM_072022)

 

The Position

Location: GREECE, SPAIN, ITALY

Position in the Organisation: Group Quality                        

Direct reports: Group Compliance and Regulatory Governance Senior Manager

 

Summary

 The position holder will be required to deliver the following strategic objectives:         

  • Management, deployment, coordination of Legal Quality Contracts program including, QP to QP Agreements, SDEAs agreements and consultation on quality terms of commercial contracts
  • Supporting on Supplier and Service Provider Quality Agreements
  • Supporting cross functional stakeholders and sites on matters pertaining to Legal Customers and Supplier and Service Provider Contracts compliance.

Main Duties & Responsibilities 

 The Quality Contracts Manager   is responsible for:

The overall direction, coordination of all Legal Quality Contracts program at Group level,

ensuring consistency with Company Strategy, Group Quality requirements, commitments and goals. 

In particular shall:

  • Analyze the risk of signed legal quality contracts clauses and plan of the appropriate mitigation plans
  • Monitor Health Authorities websites, industry dedicated sites for update.
  • Maintain the Legal Quality Contracts mapping including the QP-QP agreements.
  • Issue and review in regular basis the Annual Group Legal Quality Contracts Plan based on a risk assessment and monitor and report the Group Legal Quality Contracts KPIs.
  • Lead and coordinate  the review of the Legal Quality Contracts, including QP-QP agreements and SDEAs with internal stakeholders.
  • Support on Supplier and Service Provider Quality Agreements
  • Interact with customers as the key contact to define the appropriate strategy on Legal Quality contracts, negotiate until signature.
  • Consult on quality terms of commercial agreements and coordinate the review with the sites’QA.
  • Keep up-to-date the Legal Quality Contracts documentation repository.
  • Provide guidance and support to the sites and functional stakeholders in inquires related to legal quality contract legislative requirements.
  • Author and/or Reviewer of assigned Written Procedures and contribute to the training as applicable.
  • Originator or Coordinator of FAMAR Quality System as applicable by opening, reviewing and/or approving relevant records (e.g. deviations, CAPAs, Change Controls).
  • Follows and complies to  all good practices (GxP), to the Quality Management System, regulatory requirements, internal processes and procedures, company guidelines, the corporate governance code and all company policies and regulations, and actively contributes to their improvement.
  • Undertakes any other project or responsibility that is assigned by the company, within the broader scope of the position’s responsibilities
  • Provide Operational Support to Sites: Participation to the Program of GQA SME allocation to sites when and as requested by operations and/ or  senior leadership
  • Contribute to the Internal Inspection Programs/External Inspection Programs as an SME/Auditor.

 

The Person

Languages:

  • Fluent in English (advanced oral and written skills).
  • Italian, Spanish, Greek is an advantage.

Academic Background

  • University Degree in Chemistry/Chemical Engineering/Pharmacy/Biology. Postgraduate studies will be considered an asset.

 Special Knowledge

  • Advanced PC skills: (excellent MS skills- especially word, excel, PowerPoint), Good knowledge of Intranet applications like SharePoint as a plus.

Qualifications

  • Minimum 7 years of pharmaceutical industry experience, including 3-5 years in Quality Assurance
  • Advanced knowledge of EMA GMP legislation and associated pharma industry guidelines ( ICH, PICs, WHO, etc. ). Knowledge of FDA guidelines would be a plus
  • Knowledge of Quality Management Systems and requirements of other categories of products g. medical devices, cosmetics etc.
  • Soft skills on change management, time management, listening, autonomy, self-confidence, problem solving, results oriented, able to work under remote management.
  • Demonstrated teamwork, collaborative and consensual – A colleague that people turn to for advice and want to work with.
  • Excellent interpersonal skills as well as written and oral communications and presentation skills.
  • Strong organizational, communication, negotiation and time management skills needed to manage multiple ongoing projects simultaneously with a high degree of self-motivation and the ability to innovate, analyze and problem solve.
  • Ability to work across cultures/countries/sites and accommodate up to 5% international travel.
  • Must be able to partner with a diverse group with different strengths and skills and have the ability to prioritize work and manage multiple projects, while maintaining quality.
  • Ability to work independently and as part of a team in a very busy and fast-moving working environment

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