Quality & Regulatory Director
Full job description
J4 Resourcing
Salary: £48,000 – £54,000 per year
We are working with a fantastic pharmaceutical company that is looking to secure a Quality & Regulatory Director for the business. This is a great opportunity for the right person as they will have a huge impact on the business.
Quality and Regulatory Director
To provide leadership with respect to Quality Assurance and Regulatory Affairs to ensure that a professional and compliant service is provided.
Duties & Responsibilities
Direct Reports
* Lead Qualified Person; All company Responsible Persons; All Quality Managers
Leadership
* Support the business in identifying strategic initiatives and support the management and delivery of the company strategy.
* Actively contribute to the formulation and implementation of business strategy in order to support the achievement of financial and growth targets.
* To maintain commercial awareness when implementing quality and technical strategies, new technical services and solutions.
* To support the business in developing new revenue streams through the identification, development, implementation and leadership of commercially viable technical and regulatory services.
Quality and Compliance
* To ensure that sufficient personnel are named as Responsible Person (RP) on the Wholesale Distribution Authorisation and that the responsibilities of the RP are defined within a written procedure.
* Act as a company RP in accordance with the RP procedure.
* To ensure that all procedures across the various Group activities are in accordance with current Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
* To ensure a Quality Management System (QMS) is maintained which meets the requirements of EU GDP, GMP and the relevant aspects of the Falsified Medicines Directive.
* To ensure Quality Technical Agreements are in place for regulatory and technical services, and are valid and appropriate, thus ensuring compliance with quality and regulatory standards.
General
* Manage the setting of departmental budgets in accordance with the company budgeting process.
* To guide, support and monitor all direct reports in the continuous development of their skills.
* Ensure succession planning within the Quality and Regulatory team is in place and appropriate to the needs of the Group.
* To carry out any reasonable requests as determined by the Group Chief Executive Officer.
Person Specification
Essential
* A minimum 5 years working within a pharmaceutical business
* Detailed knowledge of pharmaceutical regulatory requirements
* Previous senior management and leadership experience
* Excellent knowledge of current GDP / GMP requirements and Quality Management Systems
* Ability to influence and negotiate with senior personnel
* Commercial awareness
* Excellent planning and analytical skills
* Proven ability to use initiative and judgment to make correct decisions
* Strong interpersonal skills at all levels throughout the business
Desirable
* Registered Pharmacist
* Eligible to act as an EU Qualified Person or named on a UK WDA(H) as Responsible Person
* Working knowledge of unlicensed medicines
* regulations in the EU and rest of the world
* Detailed working knowledge of QPulse or equivalent electronic QMS
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