Clinical Quality Assurance Manager
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3Job Description
Clinical Quality Assurance Manager
SPAULDING CLINICAL aims to be the clinical research organization by which all others are
measured. Pioneering in our approach to redefining how the industry perceives and achieves
success; passionate in our pursuit of ingenious solutions that mitigate risk; loving in our care for
our volunteers, customers and employees; and heroic in our ambitions to ensure the health and
safety of people around the globe - Spaulding Clinical is taking research beyond results to
create a marketplace of safer drugs.
Original Date: 23 Sep 2010
Revision Date:
Position Reports To: Vice President of Quality Assurance
Position Supervises: Clinical QA Staff
Job Summary:
Responsible for the Clinical Quality Assurance functions of the organization reporting to the V.P
of Quality Assurance. Ensuring planning, coordination, control, and continuous improvement of
processes and methods are established to control the quality of studies conducted at Spaulding
Clinical. Lead a team focusing on continuous improvement projects using approved tools,
design control, validations, and ensuring adherence to the agency regulations, GxP, Industry
Guidelines, local regulations, along with Spaulding Clinical policies and procedures for the
conduct of clinical trials. This involves working closely with Clinical Operations, Information
Technology, and other supporting areas/development teams, to help ensure active participation
in continuous quality improvement activities.
Essential Duties and Responsibilities:
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Develop and maintain GCP/ICH compliant processes which control the quality of work
and clinical trials conducted at Spaulding Clinical.
•
Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective
and Preventive Actions), Production support, Quality Management Reviews, and Quality
Audits.
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Lead auditing activities to ensure that studies are conducted in accordance with
sponsor protocols, GCP, industry guidelines, agency regulations.
•
Lead or assist with identifying non-conformances with requirements, provide suitable
recommendations and facilitate ongoing quality improvements using risk-based
methodology while maintaining compliance with applicable study protocols, Quality System
Regulations and or ISO standards where applicable.
•
Assist with management of contract auditors.
•
Assist in conducting vendor audits and work with vendors and production support
personnel in eliminating problems via root cause analysis techniques, to ensure that product
quality continuously improves.
•
Assist in providing training to Spaulding Clinical staff.
•
Participate in the review and installation of technology products and equipment.
Spaulding Clinical Confidential
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Clinical Quality Assurance Manager
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