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Head of Quality

Head of Quality – FTC until end of March 2022

Milton Keynes

Competitive Salary + benefits

Monday to Friday, 9am – 5pm

Our client, a leading provider of life science solutions are now looking for a Head of Quality to support their work with Covid-19 testing and clinical trials for a fixed term contract basis.

The successful candidate will lead and manage the strategic and operational performance of the Quality Department working closely with Health & Safety ensuring the successful delivery of business strategies, key performance indicators and objectives through regulatory compliance.

The Head of Quality will be expected to contribute to the strategic direction of the business and will sit on the executive and senior management teams of the client’s boards.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1.

Develop client’s Quality Management System Manual in line with the evolving needs of the business.

2.

Lead, develop, and implement and maintain the Quality Department’s strategy, to ensure it meets business requirements and customer deliverables, as well as ensuring the Department’s own performance   against goals.

3.

Lead in the implementation of necessary quality standards as required by the evolving needs of the business.

4.

Ensure  ISO9001 and ISO15189 certification is maintained

5.

Implement and monitor all management systems and the delivery and distribution of controlled documents and audit trails to ensure compliance with external audit partners.

6.

Coordinate and oversee that operations are performed in line with the management systems employed.

7.

Lead internal audits and pro-actively support and manage external audits either by clients or by external audit bodies.

8.

Lead and manage any non-conformance and opportunities for improvement processes including the management and implementation of corrective/preventative actions.

9.Ensure the development of fit for purpose company SOPs, ensuring regulatory compliance in conjunction with being both operationally and commercially appropriate.

10.Prepare, manage and justify the Quality Department’s budget.

11.Ensure that timelines and goals are achieved for accreditation initiatives.

12.

Lead and manage routine laboratory and facility measures, reporting and documentation as agreed with the Executive Management Team.

Support the Executive Management team by ensuring tests and procedures are properly understood, executed and evaluated.

13.

Provide effective day to day management, direction and guidance of direct reports in line with HR policies and procedures.

14.

Ensure that the quality team performs to high standards and meets performance objectives providing regular performance feedback and addressing development needs to maintain performance levels and succession planning.

ESSENTIAL CRITERIA:

1.

Proven experience of having established and successfully operated a quality system to at least ISO 9001 standard.

2.

Experienced in the use and configuration of Document Management Systems.

3.

Demonstrated ability to maintain a quality standard on an ongoing basis.

4.

Demonstrated ability to work in a collaborative and facilitating style with colleagues, suppliers and stakeholders on all levels.

5.

Must be able to effectively manage and influence staff at all levels of the organisation.

6.

Demonstrate excellent IT skills and literacy.

7.

Must demonstrate excellent organisational skills and be able to work under pressure and prioritise tasks.

8.

Must be able to develop and implement standard operating processes and procedures.

9.

Be attentive to details and methodical in approach to work.

10.

Can manage and control change and identify risks.

11.

Be educated to a relevant degree level or equivalent

12.

Ability to prioritise, demonstrating good time management skills.

13.

Sets and maintains high standards for self.

14.

Ensures the required high-quality standards are consistently met.

15.

Ability to manage, direct and guide other members of the team.

16.

Ability to effectively manage the performance of staff in line with procedures.

DESIRABLE CRITERIA:

1.

Experience gained in working in a life science or medical environment.

2.

Experience in IS0 15189 implementation or maintenance.

3.

Experience in developing/leading quality strategy for a previous organization. 

The above list of responsibilities is not exhaustive.

For a full Job Spec please call Vanessa on 0203 750 0575 Ext 310.