- 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 company 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 the company ready to achieve new milestones and help patients worldwide.
- 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 company 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.
- BS Preferred (open to 5 + years' experience in lieu of degree)
- Vendor Quality Management Exp. in Pharma industry
- cGMP
- Project management
- MS Office
- Relationship building
- Negotiation
- Auditing
- SAP
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Quality assurance manager - Groton, United States - Randstad
Description
job summary:
job type: Contract
salary: $ per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
