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**GCP** QA Sr. Manager Process QA - REMOTE

Employer
Labcorp
Location
Maidenhead, United Kingdom
Salary
Competitive
Start date
30 Aug 2022
Closing date
28 Sep 2022

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Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Responsibilities:
  • Engage, prepare and lead quality management reviews and interface with leaders to drive process improvements and creating a culture of quality.
  • Oversee quality data for the functional areas the position is supporting and drive proactive means of quality management. Identify trends and areas of opportunity.
  • Messages to RCQA and functional unit leaders the results of trending and signal detections of identified non-compliances and partners to provide insight and direction on the development appropriate improvement plans
  • Engaging and driving quality management and inspection readiness within the organization.
  • Ensure the consistent implementation, use and review of SOPs
  • Publish and communicate metrics and ensure appropriate actions are taken, when needed
  • Interpret applicable quality regulations/standards and create appropriate policies and procedures
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
  • Communicate escalation issues to management in a timely manner implementing appropriate solutions, including preventative actions and providing regular updates
  • Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
  • Ensure appropriate data analysis is performed in order to provide direction or lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
  • Act as the RC&QA solutions partner for operations to drive a strong culture of quality and compliance
  • Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
  • Represent Covance during external meetings/conferences/seminars as an industry SME
  • Perform other duties, as assigned by management


Minimum Experience Required:
  • 10 years in regulatory environment ( experience in GCP roles )
  • Experience & regulatory expertise of clinical industry quality systems/standards
  • Ability to interpret applicable regulations/standards
  • Ability to analyze and interpret data in order to lead process improvement initiatives
  • Ability to communicate and negotiate with internal stakeholders effectively
  • Ability to distill critical information
  • Ability to effectively lead project teams to implement change


Education/Qualifications/Certifications and Licenses

  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
  • Experience may be substituted for education.


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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