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QA Manager (cGMP - Pharmaceutical) JD818758

JD818758

DPS is seeking an established and knowledgeable Quality Assurance resource to work with a pharmaceutical client in the Boston, MA area. Successful candidates should have previous experience providing QA support of internal and external audits of sites for testing and manufacturing activities at all stages of product life cycle. Providing support for other QA activities will also be included in the role. This position requires travel 25% of the time domestically and internationally.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
10+
Date Posted:
01/10/2019
Days Remaining:
39
Employment Type:
Full-time
Education Level Req.:
Bachelors

QA Manager (cGMP – Pharmaceutical)                 JD818758

Cambridge, MA area

 

DPS is seeking an established and knowledgeable Quality Assurance resource to work with a pharmaceutical client in the Boston, MA area.  Successful candidates should have previous experience providing QA support of internal and external audits of sites for testing and manufacturing activities at all stages of product life cycle. Providing support for other QA activities will also be included in the role.

 

This position requires travel 25% of the time domestically and internationally.

 

Responsibilities:

  • Responsible for supporting the organiz186652.789361ation with initial and ongoing compliance assessment of drug product and drug substance manufacturing and testing sites in preparation of the launch of products.
  • Review of testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and testing.
  • Perform evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
  • Responsible for developing, maintaining, and executing GMP audit schedules, plans, follow-up, and close-out.
  • Responsible for coordinating GMP vendor qualification processes.
  • Responsible for coordinating material review board (MRB) meetings including agendas, material preparation, and meeting summaries.
  • Responsible for maintaining vendor inspection histories for all contracted vendors (GMP/GLP/ GCP).
  • Responsible for establishing and maintaining quality metrics.
  • Lead a team of full-time employees and contractors.
  • May perform audits and lead risk assessments.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • 10+ years’ experience in biotechnology or pharmaceutical industry with previous supervisory or managerial experience.
  • 5+ years in Quality Assurance with experience in both paper and electronic based systems including 21 CFR Part 11 compliance.
  • Certified Quality Auditor preferred.
  • Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company.
  • Experience in dealing with both US and EU Quality requirements.
  • Qualified to conduct Quality Audits.
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