Senior Quality Assurance Officer - Worthing, West Sussex, United Kingdom - Allergy Therapeutics

Allergy Therapeutics Worthing, West Sussex, United Kingdom

1 week ago

Description

We have an exciting opportunity for a Head of Quality Assurance. This is a newly created role as part of our newly created Senior Quality Leadership Team. You will own and drive the site quality improvement agenda. You will manage the Batch Release, Quality Systems and GMP training teams.

You will be an experienced QA professional and be a QP, with substantial experience leading teams in an operational quality environment (of which a significant amount should include managing QA teams) and you will be able to demonstrate strong leadership, coaching and influencing skills.

We are looking for someone with in depth experience across multiple quality systems who is able to lead multiple quality improvement activities within cross functional teams, as well as the ability to advise and act on complex quality issues – e.g.

business processes, root cause analysis, document control and traceability.

Defining and driving the vision and strategy for the site QA function
Being accountable for the performance of the Quality Assurance function; responsible for setting the quality standards, targets, measures, and has oversight for the provision of the metrics
Ensuring all products, processes and operations within the Worthing site are fit for purpose, adhere to relevant regulatory requirements and match the Company's marketing commitments
Ensuring that the function signs off accurate and fit for purpose Deviation/Complaint investigations to identify root cause and establish appropriate actions
Ensuring the PQS meets the requirements of the licences, and current standards, legislation and guidance and directs the site in the use of the PQS and where required supports the development and implementation of the electronic QMS
Leading Quality Council and Change Management forums, and (where required) escalation of adverse trends/metrics/performance to the Executive
Driving ownership for delivered quality and compliance and ensures all QA processes are lean and efficient through use of performance management tools
Play a lead role in support of audits/inspections by customers, internal auditors and external regulatory bodies. Ensuring the QA function and site is continually inspection ready and supports development of site CAPA and responses
Developing and improving the site processes for Document Control and Training
Reviewing and approval of reports, procedures, policies, critical and major non-conformances, complaints (etc) as required and determines the acceptability of data
Leading the Quality Assurance teams, ensuring high levels of team and personal engagement and leading the teams through change
Leading complex initiatives outside the Quality Unit duties and at a site level to meet business strategy
Ensuring that an effective system for continuous improvement is maintained across the company and its operation meets with regulatory and customer expectations

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