Quality System Manager

Cambridge, MA 0000

Job Category: Manager Job Number: 154694

Job Description

Job Title:               Quality System Manager

Location:               Cambridge , Massachusetts, US

Job Type:               Contract

Duration:               9-12 Months With Possible Extension

Job Description:

  • Support development, implementation, and oversight of quality & compliance activities in support of  Quality Standards and Compliance (QSC) team under Global Safety Operations, which include, but are not limited to the following:
  • Supports compliance evaluation and review function
  • Helps to track and monitor quality system KPIs / QPIs to conduct analysis for Client’s Global Patient Safety (GPS) Organization
  • Develops and reports pharmacovigilance compliance metrics related to GPS activities to ensure appropriate levels of operational performance & compliance documentation, monitoring, and follow up of CAPAs related to PV operations activities to address GPS compliance risks and ensure timely completion development of content for SOP documentation & management, as requested

Skills:

  • Minimum of 4 years in the pharmaceutical or life sciences industry with a focus on PV operations, PV quality assurance, or PV compliance. Knowledge of  relevant FDA, EMA and International Conference on Harmonisation (ICH) guidelines, including Good Vigilance Practices (GVP) guidelines. Working knowledge of MedDRA coding and Argus Safety database a plus.
  • Demonstrates expertise related to understanding the principles and application of quality and regulatory compliance
  • Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to PV quality management.

Education:

  • Bachelor’s degree in life sciences or related field required

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Recruiter:         Debasis Banerjee

Email:               Applyjob@askstaffing.com

Phone:               678-785-3670

Meet Your Recruiter

Debasis Banerjee
Team Lead - Recruitment & Delivery

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