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    Quality Assurance Manager

    Vigene Biosciences
    Rockville, MD 20850
    Full-time, Part-time
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    Job Description

    Job Description

    Title: Quality Assurance (QA) Manager

    Department: Quality Assurance

    Reports to: Director, Quality Assurance

    Location: Rockville, Maryland

    Company Overview

    Vigene Biosciences, Inc. provides viral vector-based gene delivery services and products for research and clinical applications. We are proud to support scientists at any stage of research: from basic research, to animal studies, to clinical trials and commercialization. Our diverse customer base includes thousands of scientists all across the world from academia, government organizations, research institutes, biotechnology companies, and pharmaceutical companies.

    Job Summary

    The Quality Assurance Manager is responsible for developing and overseeing the implementation of the quality systems required by the CGMPs

    Essential Duties & Responsibilities

    • Manage Quality Assurance personnel
    • Manage aspects of the Quality System to include but not limited to Quality Events, Quality on the floor batch records
    • Assist with continuous improvements efforts within the manufacturing
    • Be a cGMP officer to ensure site is inspection ready
    • Provide regular training for the QA/Quality Control (QC) team members and to company employees to ensure proper cGMP knowledge
    • Participate, in the absence of the QA Director, in Project team meetings internally and with clients
    • Ensure the quality system is followed and adhered to for cGMP projects during the manufacturing process
    • Perform internal and external audits of the Quality System
    • Take part in tracking audit responses and implement corrective action plans to ensure compliance to regulatory requirements
    • Assist the Director of Quality Assurance with various external program audits and reviews
    • Identify quality assurance concerns and provide recommendations for addressing those concerns
    • In collaboration with the Managers, conduct random quality assurance testing of services to clients to determine quality of service and developing corrective action plans if services are not meeting expected outcomes
    • Conduct quarterly reviews of all serious occurrences and compile a quarterly report for the Directors including recommendations for quality improvement
    • Other responsibilities as needed

    Non-Essential Duties & Responsibilities

    • n/a

    Supervisory Responsibilities

    • Direct reports: QA Associates; QA Specialists

    Knowledge & Other Qualifications

    • Bachelor of Science in life sciences or related field
    • 5-7 years of QA and/or QC experience in a cGMP/FDA regulated industry
    • 2-3 years of Management experience
    • Knowledge of General Manufacturing Practice (GMP) and International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use (ICH) regulations
    • Experience with personnel/talent development in Quality Assurance teams

    Other Characteristics

    • Critical decision-making skills
    • Previous experience in CDMO and/or gene therapy industry preferred
    • Ability to handle pressure and meet deadlines
    • Ability to manage multiple projects
    • Effective communication (verbal and written), interpersonal and teamwork skills
    • Self-motivated with the ability to prioritize and execute tasks to meet strict deadlines
    • Microsoft Office Experience (Word, Excel, PowerPoint, etc.)
    • Acute attention to detail with excellent organization skills
    • Gene Therapy experienced desired
    • Authorized to legally work in the United States without visa sponsorship 

    Physical Requirements/Work Environment/Travel Requirements

    • Must be able to lift up to 25 lbs.
    • Standing, sitting, walking, pushing, pulling, bending

    Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

    COVID-19 considerations:
    We have established multiple policies to protect our employees' health & safety while allowing essential operations to continue following social-distancing & PPE guidelines. Non-essential departments are working remotely and/or working alternative hours.

    Posting ID: 598939485Posted: 2021-01-20