Working as a key member of the newly created Senior Quality Leadership Team, the Head of Quality Assurance is responsible for leading the business’ strategic approach to Quality Assurance.
They will own and drive the site quality improvement agenda and will be the decision maker for the function with autonomy to make operational decisions.
The role holder will be responsible for ensuring an effective and regulatory compliant product to patient journey. They will have oversight of GMP practices, ensuring that the site complies with GxP, European and company standards. They will be accountable for ensuring there are adequate systems, processes and people to support the release of products in line with required regulatory standards.
- Responsible for ensuring all products, processes and operations within the site are fit for purpose, adhere to relevant regulatory requirements and match the Company’s marketing commitments
- Defines and drives the vision and strategy for the site QA function
- 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
- Ensure 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
- Accountable for ensuring that the function signs off accurate and fit for purpose Deviation/Complaint investigations to identify root cause and establish appropriate actions
- Lead role in support of audits/inspections by customers, internal auditors and external regulatory bodies. Ensure the QA function and site is continually inspection ready and supports development of site CAPA and responses
- Develop and improve the site processes for Document Control and Training
- Lead 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
- Leads complex initiatives outside the Quality Unit duties and at a site level to meet business strategy
- Substantial experience leading teams in an Operational Quality environment (of which a significant amount should include managing QA teams)
- Experience of fronting multiple Health Authority inspections and internal audits
- In-depth experience of using multiple Quality systems and of Data Integrity
- Practical experience preferably from aseptic manufacturing, in a management role
- Strong people focussed manager with leadership, coaching and influencing capability
- Able to prepare reports covering complex investigations/topics for presentation to senior level for approval
- Work experience across multiple GxPs
- Familiarity with electronic QMS systems e.g. TrackWise, LIMS, Documentum, Montrium
- Educated to degree level in relevant subject
- Full time role
- Site based with some remote working