Quality Assurance Manager - Groton, United States - Pfizer

Description

Current Good Manufacturing Practices (CGMP)
Manufacturing Quality Assurance
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 Pfizer 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 Pfizer 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 Pfizer 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
Proficient with Microsoft Office products
Strong relationship building skills
Negotiation experience preferred
Auditing experience preferred
Experience with SAP preferred

Rate/Location:
$46 - $51 per hour
This is a hybrid role in Groton, CT; candidates will be required to report onsite 2-3 days per week

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment.

Contractors are hired and employed through Atrium, our third party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment at Pfizer.

The individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer.

The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting.

The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.

In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.

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