Site Quality Manager

Location
Devon
Salary
Competitive Salary Package
Posted
01 May 2019
Closes
29 May 2019
Ref
J5631411
Contact
Tara O'Brien
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Site Quality Manager to join a leading Science and Engineering company based in at the UK manufacturing site. As the Site Quality Manager you will be responsible for the overall leadership of the Quality Team in Devon. The Quality team hold ownership of all advice related to approval, regulatory compliance and all quality management related topics. As such the team guarantees that products are delivered with high quality and outstanding reliability.

The Site Quality Manager acts as a partner with suppliers, customers and internal stakeholders such as Operations, Sales, Purchasing, Strategic Sourcing, Engineering and R&D, both based locally and across all other Biotechnology sites.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Site Quality Manager will be varied however the key duties and responsibilities are as follows:

1. Quality Management - Accountable for implementing quality performance targets and strategy, and managing Quality at the UK manufacturing site for base business under the direction and supervision of the International and Global Quality Leader Biotech Consumables.

2. Strategic - Develop specific Quality goals in line with Biotechnology Business Unit targets, Corporate polices and regional QM direction from . Responsible for identifying Quality considerations and communicating them to the International business QA lead.

3. Quality Assurance - Management of local QA, supervise quality related activities and quality control. Initiation of appropriate statistics for production control, responsible for investigations and resulting action plans plus approval of corrective / preventive actions.

4. Customer / Complaint Management - Accountable for execution of customer audits. Responsible for ensuring audit plan is set and conducted. Accountable as focal point for customer notifications, questions, complaints, documentation and certification requests related to products manufactured at Ilfracombe. As such, responsible for the timely response to those request and coordination of required information with other groups in the facility.

5. Supplier Management - Quality monitoring within supplier management program: Responsible to ensure compliance with Biotech standards and requirements, those are to be identified and communicated to the local procurement leader. Management of supplier related QA aspects.

6. Regulatory Affairs - Responsible and accountable for implementation of product specific legislation, RA requirements in the compliance programs, general requirements advised by Corporate QA&RA, and local/international legislative requirements for products made, with support from the RA Director.

7. Review and approval of product changes (material, supplier) and decide on re-qualification / revalidation in cooperation with Global Biotech QA Lead.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Site Quality Manager we are looking to identify the following on your profile and past history:

1. Deep and current knowledge of Quality Management principles in Commercial and Manufacturing environments with associated industry and international regulations and standards required (cGMP) in the healthcare industry.

2. Working knowledge of Biotech industry related regulatory compliances and appropriate ISO standards

3. Proven success of building and leading a team and developing talent; demonstrated leadership capabilities outside of your direct team

Key Words: Quality Assurance, Quality Management, GMP, ISO 13485, Leadership, Biotech, Consumables, Filtration, Purification, Regulatory Affairs, Manufacturing, Quality Audit

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.