Quality Assurance Manager (Clinical Diagnostic)
- Recruiter
- Covance
- Location
- Derby
- Salary
- Competitive
- Posted
- 06 May 2021
- Closes
- 07 May 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
Covance by Labcorp is looking to hire a QA Manager, with Clinical Diagnostis experience to join our expending team in our new site in Shardlow.
The main responsabilities will be:
* Manage ISO 15189 accredidation
* Ensure appropriately trained resources are available, whilst providing guidance and consultation for the team, in order to make sure that tasks are completed according to procedural requirements
* Ensure the consistent implementation, use and review of SOPs
* Escalate issues to management in a timely manner, implementing appropriate solutions including preventative actions
* Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
* Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
* Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
* Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
* Interpret applicable quality regulations/standards and create appropriate policies and procedures
* Lead interactions with clients or regulatory agencies
* Recruit, train, coach and develop individuals based on their development or business needs
* Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
* Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
* Perform other duties, as assigned by management
Education/Qualifications:
* A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
* Experience may be substituted for education.
Experience:
* 5 to 8 years in regulatory environment (ISO 15189), with Clinical diagnostics experience
* Experience & regulatory expertise of industry quality systems/standards
* Ability to interpret applicable regulations/standards
* Experience in leading process improvement initiatives
* Ability to communicate and negotiate internal stakeholders effectively
* Ability to supervise resources in a single geographic location
The main responsabilities will be:
* Manage ISO 15189 accredidation
* Ensure appropriately trained resources are available, whilst providing guidance and consultation for the team, in order to make sure that tasks are completed according to procedural requirements
* Ensure the consistent implementation, use and review of SOPs
* Escalate issues to management in a timely manner, implementing appropriate solutions including preventative actions
* Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
* Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
* Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
* Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
* Interpret applicable quality regulations/standards and create appropriate policies and procedures
* Lead interactions with clients or regulatory agencies
* Recruit, train, coach and develop individuals based on their development or business needs
* Complete thorough, timely and well documented performance evaluations providing objective feedback to the individual
* Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
* Perform other duties, as assigned by management
Education/Qualifications:
* A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
* Experience may be substituted for education.
Experience:
* 5 to 8 years in regulatory environment (ISO 15189), with Clinical diagnostics experience
* Experience & regulatory expertise of industry quality systems/standards
* Ability to interpret applicable regulations/standards
* Experience in leading process improvement initiatives
* Ability to communicate and negotiate internal stakeholders effectively
* Ability to supervise resources in a single geographic location