Head of Quality - Ophthalmology - Hampshire


South East (Excluding London)


Evolve Selection Logo View company profile

Reference: 6090

Evolve Selection are currently recruiting for an exciting new opportunity with a dynamic and supportive Pharmaceutical organisation. Our client specialises within the Ophthalmology market, and are now looking for a Head of Quality to join their already established team, based at the company’s head office in Fareham. The main purpose of this role is to strategically work with Quality Management Systems to support business growth and ensuring adequacy of systems and processes to meet business needs and quality standards and regulations.

A background in medical devices and/or pharmaceuticals.
A minimum of 5 years’ experience in a Quality role.
A minimum of 1 years’ experience in a Managerial/Supervisory role.
Certified Lead Auditor through recognised organisation.
Minimum BSc (Hons) Degree in Sciences, Engineering, or equivalent.

Role Responsibilities:
Lead and mentor Management Team, Senior Management Team in the requirements of Quality and Compliance.
Liaise with Notified Body, Competent Authority and QPPV regarding potential and actual reportable vigilance issues.
Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to.
Ensure that the company’s products comply and are released in line with the requirements of the Medicines and Medical Devices Regulations.
Maintain the Quality Manual, ensuring it is reflective of current practice always.
Alignment Quality Management System with scope of the company’s Healthcare certifications and with the company’s Healthcare Quality Policy.
Ensure compliance to GDP and company logistics policy.
Ensure Good Pharmacovigilance Practice requirements and followed and met.
Advise on product development from a Quality and Compliance perspective.
Manage the Quality Management Review Process.
Manage all internal and external audits, including hosting external audits/inspections at the company.
Management of Quality Management System SOPs and associated documents.
Manage training process for internal personnel, and external personnel where applicable.
CAPA management including EC Vigilance reporting.

Role Specific Competencies:
Leadership skills.
Ability to educate and mentor others.
Attention to Detail.
Ability to work under pressure.
Deadline driven.
Adaptable to changing priorities.

Recruitment Process:
2 stage process.

Flexible salary and benefits DOE

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