The Quality Manager and Responsible Person will provide leadership for the development, maintenance and communication of the Quality Management System (QMS) in compliance with local & corporate requirements and with national & global regulations. The role initially will be focused on the UK with scope to progress into a global role within 12-18 months.
(A) To manage and maintain a robust quality management system to support the Company freight activities.
(B) Oversee and coordinate the quality assurance and compliance programme at a country level.
(C) Provide support in the promotion and assessment of compliance with regulations, guidelines and operating procedures among sites within the region.
(D) Drive tactical Quality initiatives while working directly with internal and external customers, suppliers and regulatory bodies.
(E) Carry out audits of the Quality System and ensure inspection readiness.
Liaising with Global Quality colleagues on Quality topics
· GxP Knowledge (Essential)
· Responsible Person Training (Preferred)
· Lead Auditor Training (Preferred)
· Ability to convert regulatory requirements into a robust quality system
· Excellent interpersonal and communication skills, decisive and objective
· Good working knowledge of EU Good Distribution Practice (including the Falsified Medicine Directive) and ISO 9001.
· Existing knowledge and experience in the quality discipline
· Supply Chain and Quality background (ideally including pharmaceutical)
· Excellent knowledge of general Quality Management principles, international Quality Assurance standards and regulatory requirements (ISO, AEO, GDP, FMD, Home Office guidance etc.)
· Experience of continuous improvement methodologies
· Strong analytical background
· Effective time management
Able to plan and organise workload to meet functional objectives
1. Integrate into the Company environment with an understanding of the importance of your role, key responsibilities and relationships with fellow team members
2. Support the formulation and implementation of the Quality strategy for the UK:
a. Assess the Quality Assurance and regulatory compliance needs
b. Design Quality systems capable of meeting requirements
3. Maintain and improve the Quality Management System matching regulatory and customer standards (ISO, GDP, FMD):
a. Quality risk management
b. Complaint and deviation reporting and management
c. CAPA identification and implementation
d. Change control
e. Training management system
f. Document management and control
g. Supplier and agent due diligence and customer bona fides
h. Audit and self-inspection programme
i. Premises and equipment
j. Transportation and temperature control
4. Engage with functional leaders and subject matter experts to assess the need for operational standards; act as author and/or approver of Operational Policies, Procedures, Guidelines and Templates
5. Establish Quality operational metrics and KPIs for process control, communication and performance improvement
6. Work with internal and external customers and suppliers to resolve Quality related issues and drive root cause/corrective actions to prevent recurrence
7. Manage audit programme for external and self-inspections; scheduling auditing, reporting and findings resolution
8. Host audits from Regulatory bodies and customers
9. Assume responsibility as named UK Responsible Person for the WDA and maintain compliance in line with EU GDP.
10. Identify and execute projects leading to standardisation, simplification and improvement of existing Quality processes ensuring compliance with regulations and requirements
11. Maintain up to date Pharmaceutical and Freight industry knowledge, keeping abreast of hot topics and challenges
12. Monitor regulatory environment and report changes in Quality and Regulatory compliance requirements
13. Work with key customers and Operations teams to develop optimum continuous improvement solutions to defined requirements that add value to the current relationship, improve margin returns and ensure client retention
As responsible person, the employee must have appropriate competence and experience as well as knowledge of and training in GDP. In the role of Responsible Person, the employee should be continuously contactable. The Responsible Person may delegate duties but not responsibilities. In times of absence, the Responsible Person must formally delegate tasks to other suitably trained personnel.
The Responsible Person has authority to take decisions in relation to the below defined responsibilities:
(i) ensuring that a quality management system is implemented and maintained;
(ii) focusing on the management of authorised activities and the accuracy and quality of records;
(iii) ensuring that initial and continuous training programmes are implemented and maintained;
(iv) coordinating and promptly performing any recall operations for medicinal products;
(v) ensuring that relevant customer complaints are dealt with effectively;
(vi) ensuring that suppliers and customers are approved;
(vii) approving any subcontracted activities which may impact on GDP;
(viii) ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
(ix) keeping appropriate records of any delegated duties;
(x) deciding on the final disposition of returned, rejected, recalled or falsified products;
(xi) approving any returns to saleable stock;
(xii) ensuring that any additional requirements imposed on certain products by national law are adhered to.
Salary GBP50,000 plus GBP3,000 car allowance
* We are only able to accept applications from candidates with previous experience for this role.
If you do not hear from us your application has been unsuccessful.