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Job Description:

The QA & RA Director EMEA (RQA) is responsible for the oversight and implementation of the UPS Healthcare Quality Management System (QMS), UPS Healthcare Standard Operating Procedures (SOPs), processes and policies required to manage and control UPS Healthcare’s Storage, Distribution and Transportation Facilities. With regional oversight support the GMP DCs, GDP sites and regional third party service (GDP & GMP) providers understand and practice quality requirements, and meet UPS Healthcare’s, our client’s and regulatory agency expectations.

The Quality Management System is a collective, interrelated and interactive group of defined processes and procedures that must be implemented and adhered to in order to achieve and maintain a high quality standard. These processes and procedures incorporate the current requirements of Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.accredited program and adherence to UPS Healthcare Quality Standards (SOPs), local laws and authority regulations, and customer requirements.

This figure is responsible to attend and support inspection and visits, performed by the local Authority and certifying body.

Main Duties and Responsibilities

RQA Director, is responsible for the Quality review, assessment and support of the UPS Healthcare operations and discrepancy/ issue management, Corrective and Preventive Action (CAPA) systems, change control and the management of change, performance of audits, and the management and reporting of key quality performance indicator targets (KPIs) for Regional Quality Council and issue escalation.

They will also be experts on UPS Healthcare operational SOP requirements and associated documentation, deliver training/ development of staff on SOPs and processes, manage UPS Healthcare training records (internal staff and 3rd party providers), monitor quality performance, upgrade CAPA quality and timeliness, perform Global GMP (Good Manufacturing Practices) GDP (Good Distribution Practices) quality audits, manage external audits of UPS Healthcare by our clients and perform audits of 3rd Party Service providers in conjunction with the UPS Healthcare Approved Supplier (ASL) team.

What you'll do:

Provide Quality leadership and oversight of the Sr QA Managers, QA Managers and QA Specialists to ensure consistent implementation of and compliance to the UPS Healthcare Quality Management System at all locations in the assigned region.

Communicate and maintain the M UPS Healthcare quality plan to sustain the Company’s program in compliance with quality system requirements.

Ensure targets are achieved through effective quality performance monitoring, measurement, and analysis and reporting. This section may include specific working hours or details of shift change.

Effectively interact with Quality Associates, Quality Managers, Senior Quality Managers and Operations stakeholders to maintain quality and help introduce new quality objectives. Ensure effective controlled document review and approval.

Perform internal audits, host client audits as well as perform audits of external service providers as part of the vendor selection (when required) and management process, and in doing so complete audit reports and any relevant audit follow up.

Assist in the evaluation and assessment of UPS Healthcare - designated agents and/or out-sourced activities (when required)

Manage discrepancies, issues, and CAPA plans, collate CAPA data, and identify and implement quality improvement initiatives and conduct effectiveness checks.

Review and Approve the issues occurred in the region (when required)

Identify relevant quality related training needs and deliver training where required.

Identify Quality KPIs, collate KPI data and reporting. Produce KPI metrics to monitor and drive continuous improvement.

Coordinate and facilitate, and lead the Regional Quality Council and contribute to the Global Quality Council.

Oversee review and approve locations Validation, Calibration, and Preventative Maintenance programs to assure consistent implementation of the UPS Healthcare programs regionally in conjunction with the global validation team.

Review and approve the issues occurred in the region and support other regions when it is needed.

Responsibilities related to the sub-regional Quality Managers and Quality Associates:
- Guarantee the correct training of these positions.
- To do follow up to the activities done by these positions.
- To conduct at least a “1 to 1” meeting with them at least once a month.
- To define the Professional Goals annually for them.
- To support them in daily tasks and issues (not limited to the Quality Area).

Service:

In conjunction with the VP of Quality, manage strategic quality initiatives in order to support business growth.

Maintains quality service by establishing and enforcing organisational standards

What you'll need

Bachelor’s degree or the equivalent combination of relevant education and professional experience

7+ years of relevant experience, including Quality and Logistics Management

Deep knowledge and understanding of GDP and ISO Compliance

5+ years of pharmaceutical/biotechnology industry experience

Manufacturing, Logistics and Project Management experience a plus

Ensure compliance with national and international standards and legislation

Ensure timely and efficient management of records pertaining to the Quality Assurance Team.

Travel as reasonably requested by the Line Manager for the performance of duties.

Undertake any other reasonable duties at the request of the Line Manager

To support daily tasks and issues as needed.

To adhere to all company Policies at all times.

ASQ or ISO Certification preferred

Travel 25 25% to support facilities and Client Audits, depending on their base location

Employee Type:
 

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