Quality Assurance Manager - Hartford, United States - Integrated Resources

Description

Title:
QA Manager


Job Location:
Groton, CT (Hybrid)

Job Duration: 18 Months

Hybrid:
Required Onsite 2-3 days per weeks
Support US and UK time zones.


Job Description:

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.

Assess the operations executed at the supplier for their adherence to regulatory requirements, Quality Agreement requirements and client 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.

Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.

Hard Skills:
Vendor Quality Management Exp. in Pharma industry
cGMP
Project management
MS Office

Plus Skill:
Relationship building
Negotiation
Auditing

SAP
BS Preferred
(open to 5 + years' experience in lieu of degree)

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