What are the responsibilities and job description for the Global Regulatory Affairs Quality Process Manager position at Chiesi Group?
Who we are looking for
Purpose
Ensure adequate compliance and management to the Global Regulatory Affairs quality system according to internal and external requirements (i.e., Health Authorities). The candidate should be committed to working our hybrid model from the Cary, NC office.
Main Responsibilities
GRA Quality documentation (Manual, SOP, WI and best practices) related activities
- Be the GRA point of contact for Quality documentation, including questions related to their creation and maintenance
- Participate in the review of the GRA Quality documentation to verify the compliance to templates, standard terms and fit in the GRA overall quality system
- Coordinate the Regulatory related cGMP documentation within the electronic document management system. Monitor for timely periodic reviews, training completion, perform quality checks and rendering documents effective
- With the support of the GRA Quality documentation authors as necessary :
maintain the list of the available GRA Quality documentation and associated electronic-learning (e-learning) materials
Department Training Administrator (DTA) activities
oversee GXP training records for GRA and external GRA’s consultants including, maintaining professional figures, assigning training in e-learning management system, registering internal training data for GRA personnel, ensuring training is completed in a timely manner and pulling training records / reports
Archivist activities :
Support to GxP data extraction activities :
Experience Required
Education
Bachelor’s Degree in Life Sciences- required
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
