Quality Director |£100000 - £130000 per annum
Pharma & Science
South East

Quality Director

Additional Information

Location: High Wycombe
Salary: £130,000 + Bonus + Benefits
Job Type: Permanent

Job purpose
The Quality Director is accountable for establishing and maintaining a culture of quality across the Company, providing leadership and strategic guidance to the UK Quality function in order to meet the Company’s objectives and targets.

Main Responsibilities and Duties
* Lead, mentor, manage and develop the Quality teams
* Implement and lead the Quality strategy for the site
* Overall responsibility for the entire UK quality function
* Establish the tone and character of the Company’s relationship and overseeing the interaction between the Company and Regulatory Authorities
* Overseeing the regular review of the Company’s quality performance relating to systems and products; ensuring action is taken in an effective and timely manner
* The quality of products supplied by the Company, including the customer complaint investigation
* The supplier quality assessment process
* Build collaborative relationships with both internal and external stakeholders
* GMP compliance
* Sponsor and drive Quality Improvement initiatives
* To drive the quality management teams to meet the company objectives, such as KPI’s and Areas of Accountability
* Develop a team culture which is customer focussed with a primary emphasis upon adherence to requirements of the Quality Management System and Continuous Improvement
* Responsible for ensuring senior managers, in all areas, establish and maintain appropriate Quality systems and processes and effectively exercise their duty to continually review and improve these in line with GMP changes
Additional Responsibilities
* Responsible for ensuring staff are trained and aware of the importance of data integrity and potential risk to product quality and patient safety
* Ensure the Operational Quality departments adhere to agreed SOP’s
* Meet the relevant obligations under the Health and Safety at Work Act
* Provide management teams with training, motivation and coaching development to achieve effective performance standards and personal growth
* Represent the department in internal/external quality audits. Ensure timely implementation of resulting improvement recommendations or compliance gaps
* To work in multi-disciplinary teams and/or projects as required by the business
* Responsible for ensuring that employees receive appropriate training, motivation and coaching to achieve effective performance standards and personal growth
* Responsible for agreeing and managing quality department budgets

Experience and Qualifications
* Demonstrable experience working within a GMP regulated environment
* Educated to a degree level in a relevant discipline or equivalent experience
* 5 + years in a Senior QA position in a Pharmaceutical environment
* Experience of working with aseptic and sterile manufacturing processes
* Experience of managing regulatory authority relationships
* Previous experience managing high complex change programmes
* A BSc in a relevant scientific subject (Chemistry, Pharmacy, Microbiology or similar)
* Eligibility to be registered as a Qualified Person under the permanent provisions desirable
* Comprehensive understanding of EU and USFDA Regulatory guidelines and product licensing processes
* High level of technical process understanding across a range of manufacturing areas, including sterile and aseptic manufacturing

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