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Quality Assurance Manager - Groton, United States - Pioneer Data Systems
Description
Position Details:
Our client, a world-leading Pharmaceutical Company in Groton, CT is currently looking for a Manufacturing Quality Manager to join their expanding team.
Job Title:
Manufacturing Quality Manager / Pharma Industry / Hybrid Work
Duration: 20 months contract, extendable up to 36 months
Location:
Groton, CT
Hybrid:
onsite 2-3 days / week
Note:
The client has the
right-to-hire
you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group
medical insurance
plan
Job Description:
Quality Assurance Manager
Summary:
You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors.
You will be the Vendor Point of Contact responsible for the quality management of approximately 25 contract manufacturers, packager, contract test laboratories, and supply partners globally.
As a Quality Manager, you will focus on developing relationships, independently negotiating, developing and communicating Pharmaceutical quality requirements with contract vendors.
Your expertise provides quality system leadership to operational teams, drive process improvement, advancing new concepts and methodologies that will make client ready to achieve new milestones and help patients worldwide.
Responsibilities:
Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department
Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people
Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and Pharmaceutical expectations
Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate.
Provide guidance on procedures and training necessary to be in complete compliance with current GMPs
Qualifications:
Bachelor's degree preferred, or a minimum of 5+ years of experience in lieu of a degree
Vendor Quality Management experience in the Pharma industry
cGMP experience
Project management experience
Proficient with Microsoft Office products
Strong relationship building skills
Negotiation experience preferred
Auditing experience preferred
Experience with SAP preferred
Location:
This is a hybrid role in Groton, CT; candidates will be required to report onsite 2-3 days per week
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