R&D Quality Operations Consultant Quality Business Partner for R&D
Company: Ascent Services Group
Location: Duluth
Posted on: February 22, 2021
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Job Description:
R&D Quality Operations Consultant Quality Business Partner
for R&D Hi,
This is Shibham and I'm a working with Ascent Group - an ACS
company, a leading information technology services and workforce
solutions company. ACS Group works closely with Fortune 1000 firms
throughout the US and provides top talent for various staffing
needs across industries.
We currently have an opportunity for Associate Director, Research
and Clinical Development Quality Operations with one of our clients
in Boston, MA. If you are interested feel free to call me at (678)
496-7805 or reply to this email with your updated resume.
Job Title: Associate Director, Research and Clinical Development
Quality Operations
Work location: Boston, MA
Duration: 06+ months Contract
Position Summary:--
Responsible for:
Supporting all phases of Client's clinical development programs to
plan, control and improve the quality in accordance with
international standards for Good Clinical Practice
Partnering with development team(s) to drive quality within the
team(s)
Principal Responsibilities
Develop and implement quality management plan for each assigned
program
Interpret and provide key metrics to Global Development Team Leader
and cross-functional development team members
Support GCP SOP development and serve as quality operations
reviewer.
Execute risk-based methodologies for the planning and execution of
clinical protocols , assuring an ongoing cycle for Plan - Do -
Check - Act
Manage quality issues including audit reports, quality
issues/incidents, and CAPA development, working closely with RDQ
audit team and clinical development. Ensure timely implementation
and closure of CAPAs.
Facilitate the assessment and investigation of quality issues, by
driving root cause analysis and remediation. Provide expertise and
recommendations. Ensure timely review and closure of quality
issues.
Assure appropriate escalations and notification to line
management
Lead inspection readiness and inspection preparation activities,
including SME training/preparation and back room activities, and
manage back room during GCP inspections. Analyze the risks, propose
the strategy for readiness and manage the implementation of
readiness program. Provide lessons learned after each GCP
inspection.
Use knowledge of GCP, clinical development, and industry best
practices in order to provide guidance, training and input to
business partners on compliance issues. Able to adapt precedent and
develop creative and effective solutions to solve problems.
Manage temperature excursions occurring during shipment and
site/patient home storage. Collaborate with partners in Global
Clinical Supply and GMP QA to address excursions.
Mentor other Clinical Quality Operations Quality Leads; may have
supervisory responsibilities within Clinical Quality
Operations.--
--
Qualifications
Minimum of 8 years of experience pharmaceutical or biotechnology
drug development experience
Experience managing clinical quality activities and knowledge of
clinical operations
Comprehensive knowledge of all pertinent regulations
Education
Bachelor's degree required. Masters preferred
Competencies
Excellent communication, negotiation, and customer service
skills.
Demonstrated attention to detail, accuracy, excellent review and
analytical skills in a fast-paced environment.
Results oriented; able to determine approaches to assignments
Strong interpersonal skills while building/keeping/monitoring
quality and compliance
Problem-solving skills with ability to analyze situations and/or
data while considering future impact and intangible variables
Multitasks and ability to manage multiple global processes
Regards,
Shibham Jain
Sr. Associate ACS Solutions
A: 2400 Meadowbrook Parkway, Duluth, GA 30096
P: (+1) 678 496 7805 Job Type: Contract
Location: Boston, MA
Job ID: 21-01392
Date Updated: February 15, 2021 Shibham Jain is recruiting for this
position. Corporate Office
1001 Galaxy Way, Suite 405
Concord, CA 94520
925-627-4900
info@ascentsg.com Employment Verifications
Via The Work Number, employer code 105779 Additional office
locations in Chico, CA; Chicago, IL; Los Angeles, CA.
Keywords: Ascent Services Group, Duluth , R&D Quality Operations Consultant Quality Business Partner for R&D, Professions , Duluth, Minnesota
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