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Quality Investigations Manager (cGMP – Pharmaceutical) JD820660

JD820660

DPS is looking for a Quality Investigations Manager to work with a pharmaceutical client in the Cambridge/Lexington, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities. This individual will support day-to-day quality operations via oversight of elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, environmental and utility excursions, Out of Specifications (OOS), and change controls in support of biologics manufacturing production. Additional responsibilities include supporting internal and/or third party or regulatory agency audits.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
10+
Date Posted:
15/04/2020
Days Remaining:
32
Employment Type:
Full-time
Education Level Req.:
Bachelors

Quality Investigations Manager (cGMP – Pharmaceutical)        JD820660

Boston, MA area

 

DPS is looking for a Quality Investigations Manager to work with a pharmaceutical client in the Cambridge/Lexington, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities.

 

This individual will support day-to-day quality operations via oversight of elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, environmental and utility excursions, Out of Specifications (OOS), and change controls in support of biologics manufacturing production.  Additional responsibilities include supporting internal and/or third party or regulatory agency audits.

 

Responsibilities:

  • Support cGMP manufacturing and laboratory operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
  • Drives, leads, and troubleshoots internal quality investigations in conjunction with appropriate Subject Matter Experts (SMEs) to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
  • Drives, leads, and troubleshoots quality investigations at CMO/CTLs in conjunction with appropriate SMEs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.
  • Responsible for tracking and trending QMS metrics related to deviations, CAPA, and OOS.
  • Supports internal audits and/or third party or regulatory agency audits.
  • Responsible for presenting all Investigations in regulatory audits as required along with appropriate SMEs.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.
  • Responsible for developing/improving a training program for Operations personnel on conducting and writing investigations and performing root cause analysis.

 

Qualifications:

  • Bachelors of Science degree in Engineering, Chemistry, Biology or related field.
  • 10+ years’ of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
  • Must be well-versed in cGMP/ICH/FDA/EU regulations and guidelines.
  • Attention to detail required, strong communication, organiz799612.786486ational, and problem-solving skills.
  • Capable of working with minimal supervision and ability to work well with diverse groups.
  • Good verbal and written communication skills.
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