GxP Compliance Quality Assurance Manager

Job Locations US-MA-Bedford
Posted Date 1 month ago(3/2/2021 1:53 PM)
Job ID
2021-1411
# of Openings
1
Category
Quality

Overview

Position Summary:

Lead clinical and laboratory compliance quality assurance activities to ensure Ocular Therapeutix processes are compliant against the applicable regulations/directives (GCP, GLP), protocols, quality agreements and/or Standard Operating Procedures. Lead and provide oversite of Clinical Quality Assurance (CQA) approvals, Quality Data Integrity Reviews (DIR) and support internal/external auditing programs.

Support the GxP training and development of Ocular Therapeutix employees.

Responsibilities

Principal Duties and Responsibilities include the following:

  • Ensuring Ocular Therapeutix clinical and development programs are conducted in accordance with regulatory guidance.
  • Ensuring Ocular Therapeutix post-marketing surveillance procedures and processes are conducted in accordance with national and international regulations and remain compliant with current applicable guidance.
  • Providing quality support to Clinical Operations teams.
  • Supporting and facilitating GxP trainings for employees to ensure knowledge on current guidance is maintained.
  • The establishment, performance and maintenance of a risk-based program for the continual and appropriate oversight of all GCP and GLP suppliers and providing support and assistance to the Supply Chain Quality Assurance team.
  • Support the internal and external audit program. Conduct Quality assessments / audits of Suppliers, Principle Investigators and Ocular Therapeutix GLP & GCP activities, follow-up on agreed upon corrective actions and train or approve lead auditors as needed.
  • Support and/or perform Data Integrity Reviews of non-clinical/clinical studies, clinical/commercial product manufacturing and regulatory submissions as needed.
  • Develop, monitor and report on GxP Compliance QA metrics.
  • The company’s Readiness and GxP Inspection Execution Competent Authority inspections.
  • The handling of all non-clinical/clinical complaints, non-conformances, corrective actions, clinical temperature excursions and return material authorizations (RMA).
  • Perform other duties as assigned

Qualifications

Qualification Requirements:

  • Bachelor’s degree in Life Sciences
  • At least 8 years’ experience in the pharmaceutical or biopharmaceutical industry.
  • At least 5 years of GxP and auditing experience (preferable)
  • Excellent knowledge of US cGLPs and cGCPs. A good knowledge of cGMPs.
  • Knowledge or experience of auditing to both GMP and GCP requirements
  • Certified Quality Auditor (ASQ or equivalent) preferred
  • Strong interpersonal, negotiation and communication skills

 

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