Skip to Main Content
← Back to Jobs

Manager of Quality Assurance

Real Soft Inc. Cambridge ,MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Client:  A leading pharmaceutical company

Job Title: Manager of Quality Assurance

Location: Cambridge/MA

Duration: 6+ Months contract

JOB DESCRIPTION 
 

Duties:

The Manager Quality Assurance will play a key leadership role in the documentation, implementation, and on-going support of Sumitomo Dainippon Pharma Oncology’s GxP Quality systems, and associated processes and procedures. Particular emphasis will be on implementation of quality processes and systems in regards to outsourced services provided by CMOs, in support of the Clinical product manufacturing, testing, labeling and disposition for the Company’s oncology therapy products. 

Responsibilities:

•       Assists in the development, implementation, and management of quality management systems appropriate for the activities of contract manufacturing organizations (CMO) involved in the manufacture and test of the Company’s oncology therapy products, and ensures CMO adherence to GMP compliance and the Company’s quality expectations.

•       Reviews and approves controlled documents as required, including protocols, reports, document changes, master batch records etc.

•       Responsible for compliant, thorough and accurate batch review / batch disposition. Supports use of quality metrics for functional areas within the organization.

•       Conducts investigations into GMP-related issues and the management of the QA change control process.

Skills:

•       Solid understanding of quality management systems, quality metrics, and continuous process improvement principles including global cGMP requirements, and other relevant regulations and guidance to assure quality products. Expertise in medical device or combination product regulations and processes are desirable.

•       Expertise in the cGMP requirements pertaining to manufacturing operations in the United States and globally in support of global clinical and commercial production activities for pharmaceuticals.

•       Strong organizational and project management skills and focus on delivery of results.

•       Good written and oral communication skills

·         .• Strong interpersonal skills, with demonstrated ability to work in a multi-disciplinary setting, foster and nurture teamwork, and act as a facilitator to drive fulfillment of corporate strategic goals.

•       Ability to anticipate and resolve problems effectively.

Education:

Bachelor’s degree in a scientific discipline with at least 8 years of experience in GMP Quality operations, of which at least 5 years of experience supporting clinical phase cGMP Quality operations, with at least 2 years in a leadership role. Additional experience will be considered in lieu of a BS/BA degree.

Company Description
Incorporated in 1991, Real Soft Inc. (RSI) is a privately held talent agency meeting the talent needs of Fortune 500 firms across the US. We are headquartered in NJ and use recruiters both in NJ and offshore in our facility in Bangalore, India to contact candidates. Any questions or help? Reach us at info@realsoftinc.com. Looking forward to working with you!

Real Soft Inc.

Why Work Here?

Awesome company, good learning experience, Fortune 100 firm on resume

Incorporated in 1991, Real Soft Inc. (RSI) is a privately held talent agency meeting the talent needs of Fortune 500 firms across the US. We are headquartered in NJ and use recruiters both in NJ and offshore in our facility in Bangalore, India to contact candidates. Any questions or help? Reach us at info@realsoftinc.com. Looking forward to working with you!

Address

Cambridge, MA
USA

Website