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Quality Systems Manager (cGMP – Pharmaceutical) JD820659

JD820659

DPS is looking for a QA Systems 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 be expected to support day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity in support of biologics manufacturing production. Additional responsibilities include supporting/conducting internal audits and external supplier/vendor audits. This role may also require 20 – 40% travel.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
10+
Date Posted:
15/04/2020
Days Remaining:
31
Employment Type:
Full-time
Education Level Req.:
Bachelors

Quality Systems Manager (cGMP – Pharmaceutical)                    JD820659

Boston, MA area

 

DPS is looking for a QA Systems 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 be expected to support day-to-day quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, and data integrity in support of biologics manufacturing production.  Additional responsibilities include supporting/conducting internal audits and external supplier/vendor audits.

 

This role may also require 20 – 40% travel.

 

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.
  • Responsible for tracking and trending QMS metrics including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
  • Compile metrics for monthly operations reports.
  • Support the supplier quality program through review and approval of vendor change notifications, part number requests, raw material specifications, and raw material release.
  • Conduct/assist in internal audits and in external supplier/vendor audits against applicable quality system standards and regulations.
  • Represent Quality Assurance on project teams and in meetings.
  • Support the continuous improvement and oversight of Quality Management System procedures.
  • Mentor junior QA staff and be responsible for managing direct reports, providing oversight of daily activities and identifying development opportunities.

 

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.
  • ASQ certification preferred.
  • Internal and/or external audit experience required.
  • Knowledge of cGMPs as well as sound quality and regulatory principles consistent with best practices'.
  • Attention to detail required. Ability to read, understand, interpret and apply technical writing and instructions.
  • Good verbal and written communication skills.
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