Snr Manager, Quality Manager

Proclinical is partnering with a global healthcare company to advertise a vacancy for a Senior Manager, Quality Management position. The organisation specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company's products and services have been used to help care for critically and chronically ill patients. Based in Austria, this is an exiting opportunity to bring expertise and skills to an established and in-demand company.

The Senior Manager Quality Management will provide Quality leadership and oversight of Drug Product manufacturers, Testing Laboratories, Medical Devices, and Device Components suppliers, along with Finished Product Contract Packaging Organisations and Transport Service Providers. They will have hands-on experience in managing third parties' quality aspects for GMP, MDR, and GDP compliance of all commercial and development activities.

Job Responsibilities:

• Managing GMP/MDR/GDP quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers, and carriers by:
• Planning and executing vendor audits, including monitoring of CAPA progresses till completion.
• Negotiating, establishing, and maintaining quality agreements.
• Performing Gate Reviews for PPQ readiness.
• Maintaining an on-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, and HA inspections).
• Defining KQIs/KCIs and collecting data for periodic management review to identify Risks and mitigating.
• Ensuring Inspection readiness of all DP/MD/FP Vendors.
• Managing internal and external Change Controls, Deviations, Events, CAPAs, etc., related to DP, MedDev, Packaging, and distribution.
• Managing GMP compliance during Tech Transfer of DP manufacturing, assembly, Testing, and packaging by:
• Authoring, reviewing, and approving protocols, plans, and reports (e.g. Validations).
• Identifying the risks and establishing appropriate mitigation plan.
• Contributing to QM programs and GMP/MDR/GDP compliance activities as appropriate.

Skills and Requirements:

• A BA/BS, MA/MS or PhD in a scientific discipline or related field.
• At least seven years of experience in a Quality function with increasing levels of responsibility in the biotech/pharma industry.
• A strong understanding and interpretation of EU and US medical device regulations, ISO 13485, and GMP requirements for sterile manufacturing and combination products.
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Direct experience with GMP as well as clinical and commercial quality assurance.
• Proven success in third-parties' quality management with clinical and commercial products.
• 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 Josh Volpe at +44 203 800 1292 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.

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