Quality Assurance Manager

Cambridge, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Quality Assurance Manager in Cambridge, Massachusetts.  The Quality Assurance Manager role manages quality programs to improve total quality of company products and processes. This role also oversees implementation and compliance with the International Organization for Standardization and other applicable quality standards. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity. 

RESPONSIBILITIES

  • Research, analyze, and report quality trends and other data
  • Manage the implementation of quality standards, processes, tools and systems used in managing External Service Providers across GxP areas in Global Development Quality
  • Support and manage activities of the ESP GDQ governance board
  • Ensure risks and trends are evaluated to identify potential quality/performance issues in a proactive manner and to facilitate escalation to GDQ management and EDO organization, including follow-up until risks are mitigated and relevant actions closed
  • Deputize for the Chair of GDQ External Service Provider governance board
  • Act as point of contact for reviewing related standards in QA agreement with ESP
  • Coordinate and share information across groups to ensure processes are implemented and metrics are reported/followed-up on to achieve a holistic landscape of ESP across GDQ
  • Facilitate effective collaboration with the GDQ line functions responsible for daily ESP operations
  • Confirm the quality and compliance to regulatory standards of outsourced activities within respective GxP areas

EXPERIENCE

  • 5+ years working experience in pharmaceutical development
  • Knowledge of the technical development and clinical operations processes and vendor related activities
  • Knowledge of GCP, GMP, GVP
  • Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area
  • Experience in managing third parties vendors and knowledge of quality standards requirements
  • Experience in data analysis/trending using Microsoft programs and/or other tools
  • Demonstrated root cause analysis skills

EDUCATION

  • Bachelor’s degree in Life Sciences, Pharmacy/Medicine, or other related discipline required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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