Quality Assurance Manager Job at Pioneer Data Systems, Groton, CT

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  • Pioneer Data Systems
  • Groton, CT

Job 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 project support with current Good Manufacturing Practices to clinical supply packaging operations


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

Job Tags

Permanent employment, Contract work, Worldwide, 2 days per week, 3 days per week,

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