Manager, Quality Assurance

Job Locations US-MA-Bedford
Posted Date 3 weeks ago(2/1/2018 8:48 AM)
Job ID
2018-1047
# of Openings
1
Category
Quality

Overview

Oversees the development, implementation and maintenance of quality assurance systems and activities.  Oversees generation and review of documents used in good manufacturing practices.  May lead investigations, resolve potential product quality issues, or make recommendations for improvement.  Selects, develops and evaluates personnel to ensure the efficient operation of the function.

Responsibilities

  • Oversight and Support of GMP Quality Assurance Activities:
    • Provides direct QA oversight of the GMP deviation, investigation, product complaint, corrective and preventive action (CAPA), and change control systems.
    • Facilitates the investigation of deviations, complaints and adverse events associated with Ocular Therapeutix product.
    • Manages QA specialists and coordinates cross functional teams to facilitate the investigation and change control processes.
    • Leads complex deviation investigations.
    • Evaluates the impact of deviations, complaints and adverse events on product quality.
    • Identifies sources of variance in manufacturing processes and institutes corrective and preventive actions to remedy. 
    • Provides QA review and approval of CAPA.
    • Provides QA review and approval of validations and change controls.
    • Ensures compliance to internal SOPs and regulatory requirements.
    • Supports regulatory inspections as subject matter expert for deviation, complaint, CAPA and change control systems.
  • Support of Batch Review and Disposition Activities:
    • Ensures the adequacy of investigations performed in relation to manufactured drug product to support the batch release process.
    • Evaluates the impact of deviations and adverse events to product quality and assesses product or process impact in collaboration with subject matter experts.
    • Ensures that effective corrective and preventive actions are instituted in a timely manner to prevent reoccurrence of quality events.
  • Innovation and Continuous Improvement:
    • Authors and revises SOP, protocols and work instructions as required.
    • Continually evaluates quality systems supporting GMP manufacturing operations for potential improvements.
    • Generates and presents effective GMP training to the GMP operations team on relevant topics.
    • Generates and implements policies and procedures in support of the clinical and commercial manufacturing facility.
    • Generates and evaluates trend reports and metrics to measure key quality attributes in manufacturing operations.
    • Generates corrective and preventive actions from internal and regulatory inspectional observations.
  • Other duties may be assigned as necessary.

Qualifications

  • Bachelor’s degree in a Life Sciences discipline or equivalent.
  • Minimum five (5) years of relevant experience in a regulated biotech, or pharmaceutical industry. 
  • Minimum of two (2) years in a quality supervisory position performing Quality Assurance functions including deviations, CAPA, and/or batch release.
  • Working knowledge of cGMPs, FDA regulations, and familiarity with the European Community guidelines for GMP.
  • Working knowledge of drug development and strong knowledge of operations in an aseptic processing facility. 
  • Strong technical and scientific written and verbal communication skills are required.
  • Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member.
  • Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
  • Must be familiar with Microsoft Office applications.

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