- Reference: JLS101
- Location: South Wales
- Salary: £100000+ Benefits
- Type: Full time
Just Life Sciences are working with a global business who are seeking a Senior Level Quality Professional who will be a QP within the Life Sciences Sector to take the Quality Director's position within the business.
This is a senior position and as such you will have the Gravitas and Commercial Acumen to really drive the Quality function with a determination to deliver excellence in all aspects of the company operations and ensure compliance with the highest international standards of Good Manufacturing Practices, including but not limited to those required in the USA, EU and ROW.
Qualifications, Skills and Experience
- You will maintain GXP compliance and the necessary regulatory licences so that we can continue to produce, package and store medicinal products that have all the expected attributes of quality, safety and efficacy.
- As well as being the leading adviser on Quality and Regulatory strategy and tactics and act as the person named responsible for Quality on manufacturing authorisations maintained with the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
- Main Responsibilities:
- Responsibility for the site’s Quality Assurance, and Regulatory Affairs programme.
Responsible for managing departmental revenue budgets in accordance with agreed budgets.
Responsible for ensuring that site Health and Safety Policies are adhered to by subordinates.
Ensures the provision and delivery of training excellence to subordinates and co-workers with respect to current Good Manufacturing Practices.
Ensures the correct and consistent operation of the company Performance Management Review system.
Work closely with Business Development to ensure revenue earning opportunities within Quality and Regulatory are maximised.
Ensures that all quality audits, internal, external, supplier and competent authority audits are managed to ensure a positive outcome.
Consults with technical consultants as appropriate, for advice on licensing, product separation and other technical matters.
Assists in technical feasibility assessments as a basis to provide quotations for present, potential and future work.
Liaises with customers on technical matters e.g. specifications and establishment of technical agreements and other legislative requirements particularly for licensed product.
Works closely with the site leaders and site leadership teams to grow and develop a strong quality culture aimed at maintaining the highest standards of compliance and maintain the lowest risks to patients and customers.
- Degree in a scientific subject, registered as a Qualified Person and evidence of CPD.
Previous Work Experience:
- Previous experience in the pharmaceutical industry at senior level would be ideal yet Senior Candidates within the Life Sciences Sector will be considered
Well versed in all aspects of cGMP and appropriate pharmaceutical regulatory compliance directives.
Able to make judgements recognising the responsibilities to Regulatory Agencies, Customers and the Management Board.
Highly motivated and passionate about quality systems and healthcare.
If you are interested in this role then please contact
- Justyn withey at justlifesciences dot com for a confidential discussion on the role
Just Life Sciences
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