DuluthRecruiter Since 2001
the smart solution for Duluth jobs

R&D Quality Operations Consultant Quality Business Partner for R&D

Company: Ascent Services Group
Location: Duluth
Posted on: February 22, 2021

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Professions Jobs


12B Combat Engineer - Construction and Engineering Specialist
Description: Combat Engineers are essential to mission success by assisting their fellow Soldiers in tackling unpredictable environments. As a member of an Army National Guard Combat Engineer team, you 039 ll design (more...)
Company: Army National Guard
Location: Superior
Posted on: 03/4/2021

92A Automated Logistical Specialist - Supply Chain
Description: AGE REQUIREMENTS: Must be between the ages of 17 and 35 br br Keeping the back of house in order is a key factor in successful mission planning. As an Automated Logistical Specialist in the Army National (more...)
Company: Army National Guard
Location: Chisholm
Posted on: 03/4/2021

OTR Class A Company Drivers to 60 CPM and Owner Operators with Sign On Bonus
Description: br br br Class A CDL Truck Drivers Over the Road Drivers Owner Operators br br Call 877 695-0138 or Apply Online Below br Drivers can Earn up to .60 per mile to Start br We are offering (more...)
Company: Midnite Express
Location: Duluth
Posted on: 03/4/2021


OTR Class A Company Drivers to 60 CPM and Owner Operators with Sign On Bonus
Description: br br br Class A CDL Truck Drivers Over the Road Drivers Owner Operators br br Call 877 695-0138 or Apply Online Below br Drivers can Earn up to .60 per mile to Start br We are offering (more...)
Company: Midnite Express
Location: Aitkin
Posted on: 03/4/2021

Cable Technician - Full Time
Description: Mediacom is an Approved Essential Service and Critical Infrastructure Company and we are HIRING NOW br br THESE ARE REGULAR FULL TIME, LONG TERM ROLES WITH BENEFITS br br You'll find all sorts (more...)
Company: Mediacom
Location: Hibbing
Posted on: 03/4/2021

OTR Class A Company Drivers to 60 CPM and Owner Operators with Sign On Bonus
Description: br br br Class A CDL Truck Drivers Over the Road Drivers Owner Operators br br Call 877 695-0138 or Apply Online Below br Drivers can Earn up to .60 per mile to Start br We are offering (more...)
Company: Midnite Express
Location: Pequot Lakes
Posted on: 03/4/2021

Laborer
Description: br br Job Brief br br Laborer position br br United States - WI - Superior br br General laboring duties, cleaning work areas and equipment, operating smaller mobile equipment, assisting (more...)
Company: Graymont
Location: Superior
Posted on: 03/4/2021

92A Automated Logistical Specialist - Supply Chain
Description: AGE REQUIREMENTS: Must be between the ages of 17 and 35 br br Keeping the back of house in order is a key factor in successful mission planning. As an Automated Logistical Specialist in the Army National (more...)
Company: Army National Guard
Location: Duluth
Posted on: 03/4/2021

Horizontal Construction Engineers (12N)
Description: Before a road, airfield, or a building can be constructed, all obstacles must be removed from the site. As a Horizontal Construction Engineer in the Army National Guard, you'll handle the heavy lifting (more...)
Company: Army National Guard
Location: Superior
Posted on: 03/4/2021

12W Carpentry and Masonry Specialist
Description: AGE REQUIREMENTS: Must be between the ages of 17 and 35 br br Expand your construction skills and join the Army National Guard as a Carpentry and Masonry Specialist. You'll gain extensive, hands-on (more...)
Company: Army National Guard
Location: Spooner
Posted on: 03/4/2021

Log In or Create An Account

Get the latest Minnesota jobs by following @recnetMN on Twitter!

Duluth RSS job feeds