Job Details

Manager, Quality Operations

Title
Manager, Quality Operations
Accepting BioReady
Yes
Length
Full Time
Employer

BioVectra

Salary
not disclosed
Location
Charlottetown
Prince Edward Island
Date Posted
12/06/2018 - 12:45
Closing Date
25/07/2018 - 12:45
Job Description
Summary: 

BioVectra Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

BioVectra Inc. has an opening for a Manager, Quality Operations. This is a permanent, full-time position located in Charlottetown, PEI.

The candidate will be responsible for:

  • Performing batch record reviews and making product disposition decisions based on quality risk assessment principles.
  • Understanding complex quality issues to manage and approve all change controls, deviation investigations, and Lab Incidents.
  • Managing analytical, production, and stability data to observe trends and resolve issues.
  • Overseeing environmental monitoring programs, regulatory actions / recalls related to the product, and the preparation, review and approval of controlled documents.
  • Preparing annual product reviews.
  • Assessing gaps in the Quality System and its application, and introducing remediation through risk assessment, root cause analysis, risk analysis tools, and appropriate CAPA implementation.
  • Harmonizing QA and Compliance systems to ensure continuous improvement and to strengthen quality awareness.
  • Providing quality oversight and guidance to ensure required Quality and compliance standards are met.
  • Building and maintaining close communication with the client on quality items, including but not limited to: Change Management, Investigations, Master documents, CAPA, and Annual Product Reviews.
  • The ongoing audit readiness program for the 29 McCarville manufacturing site and ensuring that the Quality System is managed and maintained.
  • Participating in client and regulatory inspections of the 29 McCarville facility.
  • Travel as required.

The successful candidate for this position should have:

  • Bachelor of Science.
  • 5 years’ experience in Quality Assurance in either the pharmaceutical or biotech industry.
  • Minimum 2 years’ of supervisory experience, and proven leadership skills.
  • Experience in the design and implementation of quality management systems, and working with Regulatory Agencies.
  • Knowledge of current GMP, FDA, and Health Canada pharmaceutical regulations for APIs. 
  • Ability to analyze and interpret data. 
  • Excellent written and oral communication skills, attention to detail, and decision making ability.
Other Information: 

BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply by visisting our website at www.biovectra.com and choosing the “Apply Now” button.

Closing Date: June 25, 2018

We thank all applicants for their interest but wish to advise that only those selected for an interview will be contacted.