QUALITY DIRECTOR (Tuscany site) Ref.: SQD/ST

COMPANY 

 

Important PHARMACEUTICAL COMPANY

 

POSITION SUMMARY

The Quality department fulfills a critical role in the daily activities at the facility. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how company complies with all applicable regulations and guidance world-wide.

The Director of Quality leads the quality unit at the site and is responsible for operational and compliance performance that at a minimum meets expectation necessary to drive growth and customer satisfaction. The role will be responsible for building a high performing team and systems by addressing all current and future needs and building short and long-term quality plans for the site.

ROLE

  • Develop, implement and communicate a clear strategic vision for quality to maximize employee focus and develop a competitive advantage. 

  • The Director of Quality will maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. The successful candidate will bring an expert-level understanding of quality principles and regulatory knowledge.

  • The Director of Quality will have proven ability to maintain strong relationships with customers, regulatory organizations and other industry contacts. 

  • Lead a team of approximately 160+ department personnel and have overall responsibilities for Quality Control and Quality Assurance.

  • Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability.

  • Responsible for the quality aspects associated with materials management, manufacturing, packaging, storage and release of all products produced at the site. The Director of Quality is also responsible for compliance to global standards of cGMP.

  • Leads Quality Strategic Planning and Quality yearly objective setting that meet compliance requirements and business needs.

  • Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.

  • Oversees laboratory operations, responsible for testing/inspecting and releasing materials for use in product manufacturing and packaging and final product testing.

CANDIDATE

Bachelor of Pharmacy, Chemistry or Biology with 10+ years’ experience in pharmaceutical operations.

 

Experience in the development of innovative and action-oriented quality programs.

Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory. 

 

Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.

 

Reports to: EUROPEAN QUALITY DIRECTOR

 

LOCATION

TOSCANA

 

Invia il cv con l'autorizzazione del trattamento dei dati personali in base all’art. 13 del D. Lgs. 196/2003 e all’art. 13 GDPR 679/16 ed il riferimento della posizione all'indirizzo emailuff.firenze@standler.it

L'offerta di lavoro si intende estesa a entrambi i sessi (L. 903/77). Aut. Min. Lav. prot. nr. 1417 del 22/01/2007.

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