Remote - Research & Development ( R & D ) Compliance And Standards Manager

A highly reputable and distinguished global biotechnology corporation is currently hiring a qualified Remote Research and Development ( R & D ) Compliance and Standards Manager.

Responsibilities:

• Manages CAPAs including those arising from deviations and incidents
• Plans and conducts root cause investigations and analyses
• With direction and oversight from the management and executive levels, the Manager, R&D Compliance and Standards:
• Conducts and documents review of documents, tables, listings, figures, and submissions assigned
• Maintains documentation and tracking of Compliance and Standards activities and communications
• The Manager, R&D Compliance and Standards is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to colleagues throughout the organization.
• Understands and works to a risk-based approach, prioritizing the safety and welfare of human trial participants
• Plans, arranges, and/or conducts assessments of vendors, clinical sites, trial master files, internal operations, and others as may be indicated
• Assists in developing and maintaining quality systems and controlled documents
• May also be responsible for managing, directing, or mentoring R&D staff, and consultants or contractors

Qualifications and Skills Required:

• Proficient in Microsoft Office
• Thorough knowledge of US Food and Drug Administration (FDA) and European regulations
• BA or BS (or equivalent ex US) degree
• 3+ years’ experience in medical product research and development
• Strong analytical skills
• Strong interpersonal, written and verbal communication skills
• Professional, proactive demeanor.