Covance is seeking candidates for a QA Manager. The QA Manager will be remotely located (home-based) anywhere within the United States.
- 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.
- 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.
- Travel essential to Covance by Labcorp offices primarily located in Princeton, NJ and Druham, NC with respect to adhering to pandemic restrictions.
- A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience).
- Experience may be substituted for education.
- 8 years in regulatory environment (experience in GCP roles).
- 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.
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