- 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
- 8 years in regulatory environment (experience in GXP 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
- A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
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QA Manager - Maidenhead, United Kingdom - Fortrea
Description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 15,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are looking for a full time QA Manager to join our Quality Assurance EMEA team.
Essential Job Duties:
Minimum Required:
Recommended Education:
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
