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Quality Systems Manager

Job Description

Quality Systems Manager
Bothell, WA

Position Summary
Seeking a Manager/Sr. Manager, Quality Systems responsible for developing and implementing Quality Systems programs in support of commercialization efforts.

Responsibilities
  • Process owner for late stage and commercial quality systems including Quality Management Review, Annual Product Quality Review, and Complaints
  • Implement and manage Quality Management Review; drive the development, tracking, trending and reporting of Quality Systems metrics to ensure continuous quality improvements
  • Develop, implement, and manage the Annual Product Quality Review program for commercial products
  • Manage the Product Complaint program, which includes creation and maintenance of product complaint file, tracking status, collaborating with affected departments, responding to complainants, reconciliation, complaint trending, and regulatory reporting
  • Identify and drive continuous improvements for the Deviation, Corrective Action and Preventative Action, and Change Control Quality System programs
  • Assist with the development and implementation of electronic quality management system (QMS)
  • Assist in the development of training materials for new and revised Quality Systems
  • Other duties as assigned
Qualifications
  • BS or BA Degree in Life Science or related field
  • 8+ years of related experience in Pharmaceutical/Biotech Quality Assurance
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • Strong understanding of Quality Systems and experienced in quality systems to support commercial products
  • The successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
  • Team player with the ability to work collaboratively with other functions to comply with Quality System requirements and complete compliance assessments
  • Must possess skills and confidence to be able to effectively communicate internally and with personnel at multiple CMOs (Vendor management experience preferred)

Job Requirements

 

Job Snapshot

Location US-WA-Bothell
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Other
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-WA-Bothell
Addie Koback
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Snapshot
Ascent
Company:
US-WA-Bothell
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

Quality Systems Manager
Bothell, WA

Position Summary
Seeking a Manager/Sr. Manager, Quality Systems responsible for developing and implementing Quality Systems programs in support of commercialization efforts.

Responsibilities
  • Process owner for late stage and commercial quality systems including Quality Management Review, Annual Product Quality Review, and Complaints
  • Implement and manage Quality Management Review; drive the development, tracking, trending and reporting of Quality Systems metrics to ensure continuous quality improvements
  • Develop, implement, and manage the Annual Product Quality Review program for commercial products
  • Manage the Product Complaint program, which includes creation and maintenance of product complaint file, tracking status, collaborating with affected departments, responding to complainants, reconciliation, complaint trending, and regulatory reporting
  • Identify and drive continuous improvements for the Deviation, Corrective Action and Preventative Action, and Change Control Quality System programs
  • Assist with the development and implementation of electronic quality management system (QMS)
  • Assist in the development of training materials for new and revised Quality Systems
  • Other duties as assigned
Qualifications
  • BS or BA Degree in Life Science or related field
  • 8+ years of related experience in Pharmaceutical/Biotech Quality Assurance
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • Strong understanding of Quality Systems and experienced in quality systems to support commercial products
  • The successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
  • Team player with the ability to work collaboratively with other functions to comply with Quality System requirements and complete compliance assessments
  • Must possess skills and confidence to be able to effectively communicate internally and with personnel at multiple CMOs (Vendor management experience preferred)

Job Requirements

 
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Quality Systems Manager Apply now