Project Quality Manager

A global biopharmaceutical company is advertising a vacancy for a Project Quality Manager position in their office in Macclesfield. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.

Job Responsibilities:

• Create a Project Quality culture - 'Right First Time' in everything we do, and obtain personal commitment from all team members.
• Ensure that Quality Control resources and strategies are employed throughout project lifecycle (e.g. Supply Chain, construction, commissioning, handover)
• Develop, own and deliver Project Quality Plan & Quality Control Strategy
• Develop, own and deliver the Project audit programme (include 3^rd party audits)
• Champion 'Lessons learned' reviews and implementation of key outputs
• Champion the 'Suitable Qualified and Experience Register' for the project .
• Provide monthly reporting in the areas of Audit and non-conformance reporting

• Provide proactive identification and rectification of Project quality non-conformances

• Verify through monitoring, surveillance and review the effectiveness and implementation of the project delivery, (all project delivery elements, include both client and consultants / Contractors).
• Contribute to procurement management activities, especially the ITT process and review and approval of consultant / contractor PQPs and ITPs.
• Coach and support the Consultants and contractors in development of the PQPs.

• Champion the development of the master list of ITPs, and record progress against programme. (work with the Commissioning & Qualification Manager)
• Collaborate with the Design Manager to develop the handover / turnover documentation requirements and outline the register of expected handover documents.

• Plan and ensure rapid closure of Project improvement activities (NCNs, Lessons Learned Actions, etc.

Skills and Requirements:

• Professional/academic qualification in Construction, Mechanical, Electrical, or Process.
• Membership of an appropriate Quality professional body (CQI/IQA/TWI preferred).
• Auditor trained (IRCA Lead preferred).
• Certificate/diploma in Quality Management preferred.
• Proven extensive knowledge of Project delivery and Quality management in Construction and Process Projects.
• Experience of working with Design and Fit-out Contractors in a highly regulated environment (ideally GMP environment).
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

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 contact Steven Fuller at +44 203 854 2630 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.

Proclinical Staffing is an equal opportunity employer.

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