Details:

• Pay for this position is 130.00 to 137.93 hourly depending on experience.
• This position is a one year contract with the possibility of extension or conversion to permanent.
• Location: Cambridge, MA. Hybrid, ideally 2 days onsite per week (may be flexible).
• Title: Clinical quality Compliance Lead - Associate Director Level

Requirements:

• BA/BS degree required; Advanced Degree preferred.
• Experience in the pharmaceutical, biotechnology or related health care industry (CRO, etc).
• Minimum 7 years of GCP-related Quality Assurance experience (pharma/biotech/CRO, etc.).
• Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development.

Summary of Responsibilities:

• Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
• Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
• Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to client’s values and strategic priorities.
• Lead development and implementation of the GCP supplier audit and compliance strategy for clinical development programs, GMA and MPG studies.
• Serve as primary point person for key GCP strategic partners; lead key supplier quality partnership governance councils and/or internal supplier-related committees.