Supplier Compliance Manager

ΠΕΡΙΓΡΑΦΗ ΘΕΣΗΣ ΕΡΓΑΣΙΑΣ

About FAMAR

FAMAR is a European provider of pharmaceutical manufacturing and development services (CDMO) with a legacy of 70 years of technology expertise.

Building on its experience, FAMAR is a reliable partner to deliver flexible solutions, from development to production and distribution. Continuity and customer care are the cornerstones of FAMAR’s long-term business-oriented partnership.

Through the commitment of 1800 employees worldwide, and with a network of 6 production sites in Europe, FAMAR supplies a wide range of more than 1800 products in a variety of dosage forms, in 80 international markets.

We are currently looking for a high calibre professional to fill the position of Supplier Compliance Manager.

 

 Supplier Compliance Manager

(SCM_2.2024)

The Supplier Compliance Manager will be required to deliver the following strategic objectives:        

  • Development, deployment and oversight of an effective Supplier Compliance and Qualification Strategy.
  • Support cross functional stakeholders and sites on matters pertaining to suppliers’ surveillance, as well as the associated Quality System Performance, and ensure adherence to regulatory compliance.

 

DUTIES AND RESPONSIBILITIES:

The position holder will be responsible for the overall direction and coordination of the Supplier Compliance Program at Group FAMAR level, ensuring alignment with Company Strategy, Group Quality requirements, commitments and goals.

In particular, the position holder will:

  • Define, deploy and monitor the Supplier Compliance and Qualification Strategy, including the quality metrics for the Supplier Performance in order to drive continuous improvements.
  • Issue and review on a regular basis the Group Annual Supplier Audit Plan, based on risk assessment and coordinate the execution of the Group Suppliers Audits.
  • Be responsible for the review /approval of the Group Suppliers Audit reports and CAPAs and monitor the closure of Group Suppliers Audit observations.
  • Monitor and report Group Suppliers Quality Performance and manage the Supplier Quality Key Performance Indicators.
  • Define and monitor the FAMAR Quality Supplier auditors’ qualification.
  • Monitor applicable regulations and HAs alerts / warning letters related to Suppliers.  
  • Support sites and other functions with new product launches to ensure existing or new suppliers are suitable for the required quality standards.
  • Lead the root cause analysis and corrective actions process of significant supplier quality issues.
  • Identify process improvement opportunities, implement best practices and provide appropriate support and training to the sites to ensure consistency and harmonization across sites.
  • Support Due Diligence activities by providing subject matter expertise and enable decision making through identifying quality related risks in projects and providing appropriate resolutions.
  • Contribute in Group Quality procedures, Quality System and Training as requested.
  • Support and contribute in Inspections (Internal, Health Authorities and Customers) as requested. 

 

PROFILE / SKILLS/ QUALIFICATIONS:

General Requirements

  • University Degree in Chemistry/Chemical Engineering/Pharmacy/Biology. Postgraduate studies will be considered an asset.
  • Minimum 5 years of pharmaceutical industry experience, including 3-5 years in Supplier Qualification and participation in GMP third party audits in a lead role.
  • Must be fluent in English (advanced oral and written skills). Knowledge of the Greek, Italian and/or Spanish languages is an advantage.
  • PC literacy (excellent MS skills, especially Word, Excel, PowerPoint, Visio).
  • Soft skills in change management, listening, autonomy, self-confidence, problem solving, results orientation.
  • Demonstrated teamwork and collaborative approach.
  • Good communication skills (oral and written) with a clear and concise presentation style and the ability to convey the vision in a manner readily accessible and understandable to all.
  • Strong financial/business awareness and good negotiation skills.
  • Must be able to collaborate with diverse groups with different strengths and skills.
  • Ability to manage time, prioritize work and manage multiple projects, while maintaining quality standards.
  • Ability to work under remote management, as well as independently and as part of a team in a very busy and fast-paced working environment.
  • Ability to travel up to 50% in both domestic and international travel.

 Qualifications

  • Experience in Electronic Quality Management Systems (eQMS), Supplier Quality Management (eSQMS) will be considered an advantage.
  • Current knowledge of EU Regulations & Directives, Quality Management Systems and processes (ISO 9001, ISO 13485, ISO 22716)  as well as comprehensive knowledge of international GMP regulations and subsequent applications to medicinal products, medical devices, cosmetic and dietary supplements is preferred.