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Job Details

Quality Assurance Manager/Director

Company: ProClinical Ltd
Location: Trento
Reference: QA.IG.14638
Closing Date: 20 Dec 17
Type: Permanent
Salary (£): 100,000+
Benefits:

Job Summary:

ProClinical is seeking a Quality Assurance Manager/Director for a global medical device company, to be based in Italy on a permanent basis. This position has the primary responsibility for leading the Company’s quality assurance functions across all operating divisions and manufacturing facilities, to assure company’s compliance with applicable quality systems and GMP requirements. ...

Requirements:

ProClinical is seeking a Quality Assurance Manager/Director for a global medical device company, to be based in Italy on a permanent basis. This position has the primary responsibility for leading the Company’s quality assurance functions across all operating divisions and manufacturing facilities, to assure company’s compliance with applicable quality systems and GMP requirements. The purpose of the position is to implement and manage company-wide quality performance to achieve products of highest efficacy and safety.

Job Responsibilities:

* Develop, maintain and improve the Corporate QMS with a proactive approach, to ensure effectiveness and efficiency of systems and processes in place to satisfy global regulatory requirements, standards and directives, including those of the FDA, European agencies, Asia, and ISO applicable to medical devices industry.
* Contribute to establish a quality policy, to ensure the setting of quality objectives for all relevant areas, to periodically carry out management review in order to align QMS to effective and quality-related actions and processes across all levels of the organization
* Develop a systematic approach to Risk Management, to focus on product quality and reliability, throughout product design and development, supplier management, manufacturing, launch of new products, sales, service and marketing, at every step of the value chain.
* Define and develop a holistic approach to QM, to connect the different quality processes critical in compliance, such as document control, training management, change control, CAPA, quality audit, non-conformance disposition, customer complaints, and other related processes.
* Implement a reporting capability for effective management, to ensures that quality standards are measured, maintained, analysed, and trended for further improvement over time, and to understand quality issues in order to proactively solve problems.
* Deploy a proactive quality mindset across the organization, and a disciplined root-cause problem solving culture.
* Support the implementation of QMS in all the subsidiaries
* Develop, maintain and improve the Corporate Process Validation System, providing documented evidence that company relevant processes and systems consistently produce results meeting predetermined specifications.
* Develop, maintain and improve the Corporate Supplier Quality Management System (SQMS) and Distributor Quality Management System (DQMS) to secure highest level of quality and to realize continuous improvement throughout the entire supply chain

Skills and Requirements:

* Bachelor’s degree in a scientific discipline
* 10+ years of people management experience in medical device manufacturing.
* 5+ years’ experience managing a QA department with 3+ years in a Sr. Leadership role.
* Organizational leadership, ability to organize complex work, drive change and instil a culture of execution
* Success in effectively leading a quality organization
* Substantial knowledge of global medical device regulations like GMP, FDA, ISO
* Ability to manage change and conduct problem solving
* Proven record as a change agent improving teams, organizations, and developing best-in-class QA processes.
* Strong team player with excellent interpersonal and communication skills
* Experience working across multiple cultures

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Quality Assurance Manager/Director

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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