Quality Recruiting. Established Experts.

Manager QA

Reference Number: 3086
Location: MA

Our client is a clinical-stage pharmaceutical company focused on discovery and development of novel first-in-class drugs.  They have asked us to assist them in their search for a Manager QA.

This position works cross-functionally to support efforts to define, setup and maintain a Quality Management System (QMS) including SOPs, training system, and audit & inspection activities. This person will maintain records management for Quality Systems and is responsible for backup support for Document Control.

Major tasks and responsibilities will include:

  • Manages the QMS and acts as SOP Coordinator to ensure that the QMS is up-to-date; supports globalization of procedures; facilitates and supports creation, reviews, and approval of procedures; performs gap analyses to harmonize procedures; coordinates GxP SOPs and policies that adhere to regulatory guidance.
  • Processes quality system documents, scans and archives documents appropriately.
  • Supports user requests for documentation and updates document archive systems.
  • Provides backup support for coordinating document change, coordinates review and approval.
  • Coordinates the collation & Presentation of Quality Management Review Reports.
  • Maintains the corrective Action and Preventative Action (CAPA) Trackers and oversee implementation of related CAPA plans to ensure implementation and close-out.
  • Tracks CAPA completion metrics and provides periodic reports to management.
  • Conducts CAPA verification audits and creation of verification binders.
  • Backs up to other QA staff managing document management systems.
  • Manages and development/maintenance of QA-specific SOPs.
  • Manages the Training Program to ensure compliance with GxP/regulatory requirements; for full time employees and contractors.
  • Ensures training compliance, coordinates, tracks, and evaluates training records for FTE and consultants employed.
  • Performs audits of training files on a periodic basis and manages associated findings.
  • Assists in the development, optimization, and administration of the GxP training system.
  • Tracks training compliance and reports status of company-wide training compliance.
  • Supports QA team with regards to SOP and regulatory training needs.
  • Manages audit scheduling and status for all GxP activities.
  • Plans and coordinates GxP Quality audit activities.
  • Ensure that external & internal auditors have the necessary pre-audit documents and data.
  • Files & tracks original audit reports.
  • Tracks Deviation’s, Audit’s and Inspection’s CAPAs until closure.
  • Quality Committee meetings: Assist in the administration of QA meetings including but not limited to creating agendas, management invitations, collation of slides and generation and distribution of meeting minutes.
  • Ensures inspection readiness documents are always up to date.
  • Supports preparation efforts for any external audits and regulatory inspections.
  • Coordinates and ensures quality and prompt provision of documents requests.
  • Acts as the inspection/audit backroom coordinator.

We seek candidates with the following qualifications:

  • Bachelor’s Degree required.
  • Experience in a pharmaceutical, Biotech or medical device company environment.
  • Possess strong verbal and written communications.
  • Knowledge of GCP, GLP, GMP regulations desired.
  • Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects with company personnel.
  • Must be quality oriented and willing to promote quality standards.
  • Strong interpersonal skills, with the ability to communicate effectively with all levels of staff including nontechnical and technical personnel.
  • Experience with electronic documentation (VEEVA or VIVALDI) a plus.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3086. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.