Reference Number: JO-2105-469574
Job Type: Permanent
Location: Central London / West End
We are proud to be partnered with one of the worlds leading Pharmaceutical companies. They are seeking a Quality Assurance Manager within their Diagnostics division – a great opportunity for someone with extensive experience within this sector of life sciences!
This is a role to look after the UK, Ireland and Nordics covering the below skillset;
- Primary Objective of Position
- Ensure Quality System awareness and compliance of new and revised quality documents and regulations that affect the assigned area of responsibility.
- Supports the business in the affiliate/ region according to the position expertise and functions.
- Major Accountabilities
this can be Inclusive of
- Plan and conduct internal audits to verify the effectiveness of the management system
- Prepare/ coordinate external audits.
- Perform supplier audits as required.
- Support/provide training to the organization about the ADD Quality System.
- Ensure QS record keeping, document control, Warehousing, QH, Supplier/ Distributor evaluation/ monitoring, CAPA management follow up and ensure timely closure.
- Coordinate Field Communications at the Region.
- Ensure availability of org charts (including LSME if required) and job descriptions.
- Ensure the setting and tracking of the Training Plan for all positions.
- Assess risk related to processes
- Timely escalate regional concerns to Area Management Review and MIMS MR
- Supports Global Commercial Affiliates QA improvement projects
- Maintain/ challenge current certifications. Propose new certificates if required.
- Coordinates communication between commercial organization and Regulatory to support responses in contracts and public tenders (QARA, EHS requirements). ·
- Team/ MIMS Subject Matter Expert & Procedure Owner: Be the expert on a QS process and support the rest of team as process SME: either as lead, backup or team member.
- Review company policies & procedures, and update Quality documentation accordingly.
- Manage any audit input by initiating changes to affected processes following MIMS change control procedures.
- Identify and coordinate improvement initiatives within the entire QS.
- Participates in Quality System improvements and implementation projects
- Actively seek internal/external customer feedback and respond to issues
- If there is no regulatory function in the affiliate, perform/ ensure revision and approval of locally/translated AdPromo material on behalf of Regulatory Affairs. If needed, support RA appointing language approvers and ensure trainings are done accordingly
- Manage the QA budget, always considering cost improvement opportunities
Manager Quality only:
- Act as an expert for sales and customer support for accreditation topics, presentations and process implementation in sites where customer certification I accreditation is requested
Senior Manager Quality main accountability:
- Ensure that knowledge and experience acquired during their professional life is transferred to other team members.
- Mentor and develop other Quality Managers