- 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
- Supporting reviews / compilation of reports in support of PQR's, MAA or BLA
- Leading the Quality Assurance teams, ensuring high levels of team and personal engagement and leading the teams through change
- Owner of budget adherence and cost control measures as appropriate
- Leading complex initiatives outside the Quality Unit duties and at a site level to meet business strategy
- Developing talent through coaching and mentoring
- 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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Head of Quality Assurance - Worthing, United Kingdom - Allergy Therapeutics
Description
About Us
Allergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.
We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience; our ultra-short course treatments make life easier and increase adherence.
Our adjuvant technologies not only advance the results of allergy immunotherapy but also drive beneficial immune responses in cancer and infectious disease.
We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.
We are continuing to grow and it's an exciting time to be joining us. You will contribute to our ongoing success and be part of our future which is looking very bright
You'll join a team of like-minded people who are passionate about what they do and providing positive outcomes for our patients.
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 be the decision maker for the function with autonomy to make operational decisions.
You will manage the Batch Release, Quality Systems and GMP training teams.
About you
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.
You will be able to demonstrate good foundational knowledge and understanding of current UK and EU GMP standards and regulations as well as experience of fronting multiple Health Authority inspections and internal audits.
Practical experience (gained within a steriles manufacturing environment) as well as the ability to influence decision making and working collaboratively with peers and other key stakeholders is also key.
Experience with electronic QMS systems would also be really beneficial.
The role
You will be involved in the following:
