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Quality Manager (Biotechnology)

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2015.08.07.
Jelentkezési határidő: 2015.08.20.
Hirdetés azonosító: 935170


Quality Manager (Biotechnology)
Hays Life Sciences has been retained by a global leading manufacturer of diagnostics who wish to acquire a talented Quality Manager for their new reagents production plant in Hungary.

The purpose of the role is to support the plant start-up by developing and managing all aspects of site quality standards and Quality System.

• Manage the Quality Assurance and Regulatory Compliance staff and activities to support the transfer, manufacture and release of products in accordance with established specifications.
• Quality activities include, but are not limited to: inspection, validation, material disposition, product release, data collection/trend analysis, auditing, Quality/Compliance training.
• Manage nonconforming material, including complaint, processing, investigation and documentation. Provides quality metrics reports.
• Acts as Management Representative and main contact for all quality related matters.
• Works in conjunction with other functional leaders to assure the initial validation of the plant and its processes and the ongoing maintenance of the validation strategy.
• Works in conjunction with other functional leaders to ensure CAPA activities (investigations/corrective and preventive actions) are carried out in a timely and effective manner.
• Responsible for writing and implementation of quality procedures, strategies and policies. Reviews and approves all plant procedures and policies. Assures full implementation of cross site Change review Board.
• Is responsible for implementing and maintaining an ISO certified quality system in all departments in the facility.
• Builds an influential and effective relationship with other Plant Management Team members in order to drive overall Plant performance by leading a strong culture of Quality and Continuous Improvement.
• Recruits, manages, coaches and develops a team that achieves the business and Quality Assurance / Regulatory Compliance department and associates goals.
• Leads regulatory compliance activities (example: IACUC; REACh reporting etc.)
• Ensures all staff is trained in good quality and laboratory practices and documentation of other procedural based training.
• Identifies quality improvement opportunities within Operations and partners with peers in the Innovation center to develop and implement new processes and technologies.
• Participates in creating the department budget and pro-actively manages it to targets.
• Contributes to world-wide functional strategy and priorities and ensures effective deployment within the Plant.


• University degree in Life Sciences or Engineering discipline
• Minimum of 10 years of relevant Quality experience in Medical Device / Reagent / Pharmaceutical manufacturing industry
• Minimum of 5 years of experience in Quality leadership position including budgetary management
• Knowledge of applicable regulations (ISO 9001)
• Excellent communication and interpersonal skills are essential
• Ability to work under pressure and to tight deadlines
• Ability to work well with a team, be a good problem solver and an excellent leader
• Proven track record in dealing with regulatory authorities
• Fluent in both spoken and written English and Hungarian
• Working knowledge of: MS Office, Visio, Project planning and experience with SAP is preferred
• LEAN and/ or Six Sigma experience preferred
• Quality System start-up and project management experience preferred
• Extensive travel required in the first 6 months
Munkavégzés helye: Budapest

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