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Qa Lead Senior Manager-Remote
Company | Fortrea |
Address | , Princeton, Nj |
Employment type | FULL_TIME |
Salary | $110,000 - $145,000 a year |
Expires | 2023-10-07 |
Posted at | 8 months ago |
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 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
The QA Senior Manager Lead Contributes in generation of global QA policies on interpretation or application of Provides subject matter GCP expertise and influences the ED/CS/CDS organization by providing guidance and client/authority facing support on specific regulatory topics and Quality Issues.
What to Expect:
- Participates in client JOC or governance meetings
- Manages the QA to QA relationship with assigned key client(s)
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties, as assigned by management
- Hosting of external audits/inspections e.g. regulatory inspections, strategic client
- Supports clients in making regulatory (strategic) decisions/ issue resolution for study problems
- Provides support to Compliance Lead and Sr. management as a contributor or leader of internal functional QA RCQA initiative.
- Manages the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings) for assigned clients.
Education/Qualifications:
- Experience may be substituted for education
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
Experience:
- Ability to influence and negotiate
- Ability to manage client responsibilities
- Report and communicates key quality information to Sr. Managers and QA
- Ability to manage difficult conversations and meetings with clients
- Detailed knowledge of specific regulations/multiple regulations
- Excellent communication, interpersonal, planning and organizational skills
- Effectively lead and communicate critical issues during client meetings
- 6 years in regulatory environment (experience in GCP roles)
US Pay Range: $110,000-$145,000
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please
click here
. 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
www.fortrea.com
. 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. For more information about how we collect and store your personal data, please see our Privacy Statement.
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.
For more information about how we collect and store your personal data, please see our
Privacy Statement
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