Manager, Quality Engineering Process Lifecycle
6 months ago
Contract for 12 months in the first instance but could go longer.
Job Request Number 21733
**Client**
This role is to work with our client who is global biotech leader HQ'ed at Broadmeadows.
**Role Description**
The role, Manager, Global Quality Engineering Process Lifecycle, reports into the Associate Director Global Quality Engineering and provides quality oversight for Global Engineering Technology Transfer, QbD (Commercial), and
Validation processes.
This role will also work closely with Quality Value Stream colleagues, Global Quality colleagues, site colleagues and peers from manufacturing sites to ensure close collaboration for the delivery of capital projects and GMP compliance to regulatory requirements.
The role is required to demonstrate strong technical knowledge in the above areas of technology transfer, validation, life cycle management, product and patient safety and cGMP compliance, and will be experienced in regulatory submissions and associated regulatory inspections.
The role is responsible for QA oversight of quality procedures and systems aligned with the Global Engineering function in the above areas.
This position is part of a global team, which includes personnel located across Switzerland, Australia, the USA and Germany.
No Direct Reports
**Required experience**
3+ yrs experience across the following
cGMP and compliance, experience in change controls, deviations, quality ops desirable
Experience in validation, cleaning validation, process validation
Technology transfers - for process and facility
Experience in quality by design, classification of parameters
Familiarity with performing risk analysis - FMEA
Experience in engineering and engineering documentation very beneficial
Quality assurance
Knowledge of Regulatory requirements (FDA and European regulators)
**Other detail of note**
All onsite (potential to negotiate maybe 1 day from home down the track)
Hours: Mon to Fri standard hours (by exception may be some after hours)
Please get in touch for a full job description and would welcome opportunity to discuss further in confidence - Mairead Dunbar, 0409240719
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