Quality & Compliance Manager - Langland CTE
- 55 High St, Windsor SL4, UK
Langland is searching for a quality and compliance manager with strong life sciences experience who will take ownership of quality management and compliance to support our work as a healthcare advertising agency with a focus on the clinical trials (patient recruitment and retention) market.
You will be working with internal staff across departments to ensure we meet regulatory and legal requirements alongside the best practices expected by our clients (pharmaceutical and biotechnology firms), as well as working directly with our clients as the central point of contact for any inbound assessments, audits, and other queries.
The ideal candidate will have experience leading the implementation of a quality management system solution in the life sciences industry and able to hit the ground running to help us get our standard operating procedures and supporting documentation in place and maintain this on an ongoing basis.
This job will involve a high degree of autonomy so we are looking for somebody who is a self-starter, comfortable managing and planning their own time, and pro-active at setting the agenda for best practices.
Specific Job Criteria:
Design and Manage our Quality Management System
· Draw up initial set of required standard operating procedures
· Review existing policies and draft new policies and/or support other team members in doing so
· Set up a document management system and other systems as needed
· Set up a training matrix, ensure appropriate training is carried out and records maintained, along with other supporting documentation (official curriculum vitae’s, org charts etc.)
· Define and manage our CAPA process
· Set up an internal audit programme across the business to ensure compliance and improve quality
· Put in place processes for the selection and auditing of our vendors and subcontractors
· Drive a culture of quality and compliance throughout the whole organisation
· Keep abreast of relevant legislation and regulations that impact our business
Be the Main Point of Contact for Compliance Requests
· Triage vendor assessment requests coming from clients, working with relevant internal staff to complete these
· Co-ordinate response to audits by clients (either on site or remotely), supplying all relevant documentation and orchestrating responses from relevant team members