Quality ManagerThe Fountain Group • Lexington, MA
Quality Manager
The Fountain Group • Lexington, MA
30+ days ago
Job type
- Full-time
Job description
Job Description:
Primary Duties/Responsibilities:
Qualifications:
- The role is responsible for quality support of US Domestic Distribution Logistics (USDDL) which includes US and Puerto Rico.
- This includes quality support for Patient Assistance Program (PAP), Access to Medicines (ATM), and Physician Sample Program in the US.
- The role is also responsible for Quality support of US Global Distribution Logistics (USGDL) in regards to exports from the US to other markets.
- The role is also responsible for Quality support of US Customer Experience.
Primary Duties/Responsibilities:
- Support US Commercial Quality in support of USDDL. Perform the following activities in support: temperature evaluations, identify and initiate deviations, manage product returns, quality approver for change controls and CAPAs, and other applicable compliance activities related to our regional distribution centers (RDC)/3PL’s.
- Support US Commercial Quality in support of USGDL. Support quality approval for investigations related to exports from the US to other markets. Review and approve USGDL procedures and transport validation documents.
- Train and become proficient in Takeda’s enterprise systems: TrackWise, SAP (inventory), and Veeva. Train and become knowledgeable of the requirements related to Drug Supply Chain Security Act (DSCSA)/serialization, controlled substances (Orders of Interest), and anti-diversion/counterfeit.
- Support the management of US Approved Suppliers including 3PL’s, 4PL’s, transportation carriers, etc. Management includes participating in quality business reviews, managing quality agreements, audits, and supplier records in the Supplier Management System.
- Execute Takeda standards and procedures related to risk management, self-inspection, internal audits, Quality Council, Supplier Business Reviews and other applicable quality system elements.
Qualifications:
- Bachelor’s degree (or equivalent experience) and 5+ years of experience in Quality, preferably in the pharmaceutical industry.
- Well versed in quality activities such as supplier quality, deviations, change controls, audits, CAPAs, etc.
- Experience with enterprise systems such as TrackWise, SAP (inventory), and Veeva a plus.
Create a job alert for this search
Quality Manager • Lexington, MA
Similar jobs
Expected Travel: Up to 10% Requisition ID: 13156 About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of peo...Show more
Description Robert Half is working with a respected client in the Burlington area looking for a Manager of Quality and Continuous Improvement.This is a permanent role, reporting into a Director of ...Show more
Joining Moderna means advancing mRNA science to transform medicine.Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.Moderna is str...Show more
Quality Improvement Manager Opportunity -.South Attleboro, Massachusetts providing inpatient and outpatient behavioral health services to residents of Massachusetts and Rhode Island.Inpatient units...Show more
Location Address: 1253 W Central Street, Franklin, Massachusetts 02038 Work Shift: Salary Exempt (United States of America) Leads administration of quality, process, and business improvement effort...Show more
For over 25 years, Abcam has been providing tools the scientific community needs to enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases, and metab...Show more
Lead Quality in a Cutting-Edge, High-Tech Manufacturing Environment.Competitive Compensation and Benefits.This organization is a high-technology manufacturer specializing in advanced electronic ins...Show more
Manager, Quality Compliance Audits.MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases.We are on a mi...Show more
Responsibilities Quality Improvement Manager Opportunity - Fuller Hospital is a 109-bed licensed, private psychiatric facility located in South Attleboro, Massachusetts providing inpatient and outp...Show more
Reports To: Sr Director, Head of Quality.ITF Therapeutics is seeking an experienced Senior Manager, Quality Systems.As a key member of our Quality team, you will be responsible for continuous impro...Show more
About Analog Devices Analog Devices, Inc.NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge.ADI combines ana...Show more
Position Summary: Responsible for maintaining quality standards for Ocular's pharmaceutical and medical device products by managing activities associated with Risk Management, Supplier Quality Mana...Show more
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of the team at Thermo Fisher Scientific, you'll do important work.And you'll have the opportunity f...Show more
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.Rooted in an entrepreneu...Show more
The Manager of Quality will develop and oversee quality management systems in compliance with AS 9100.Provides overall leadership and management of all aspects of company and supplier quality for c...Show more
Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients.Obsidian's programs apply our CytoDriveTM technology in Cell and Gene therapy ...Show more
Acute Care TechnologyThis position is responsible for developing, implementing and managing quality assurance and quality control program designed to ensure continuous production of electrodes cons...Show more
Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contrac...Show more
Senior Quality Assurance Manager
Teleflex • Chelmsford, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality Assurance Manager
Robert Half • Burlington, MA, United States
Permanent
Last updated: 2 days ago • Promoted
Manager, Quality Control, Lab Automation Enablement & Integration
Moderna, Inc. • Norwood, MA, United States
Permanent
Last updated: 1 day ago • Promoted
Quality Improvement Manager
UHS • Attleboro, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality Manager
Altium Packaging LLC. • Franklin, MA, United States
Full-time
Last updated: 6 hours ago • Promoted • New!
Quality Assurance Manager
Danaher • Waltham, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality Manager
Michael Page • Burlington, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Sr. Manager, Quality Compliance Audits
MannKind • Bedford, MA, United States
Full-time
Last updated: 4 days ago • Promoted
Quality Improvement Manager
Universal Health Services • South Attleboro, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Senior Manager, Quality Systems
ITF Therapeutics • Concord, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality/Regulatory Manager
Analog Devices, Inc. • Wilmington, MA, United States
Permanent
Last updated: 2 days ago • Promoted
Manager, Quality Compliance
Ocular Therapeutix • Bedford, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Sr. Quality Assurance Manager
Thermo Fisher Scientific Inc. • Bedford, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Senior Manager, GMP Quality Assurance
Kailera Therapeutics, Inc. • MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality Manager
Gpac • Sudbury, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Manager, Quality Operations
Obsidian Therapeutics • Bedford, MA, United States
Full-time
Last updated: 2 days ago • Promoted
Quality Assurance Quality Control Manager
ZOLL Medical Corporation • Pawtucket, RI, United States
Full-time
Last updated: 2 days ago • Promoted
Manager, Quality Control Operations
Kiniksa Pharmaceutical • Lexington, MA, United States
Full-time
Last updated: 2 days ago • Promoted