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Quality Sr. Manager, Gene Therapy

Yoh Enterprise Boston, MA
  • Posted: 27 days ago
  • $60 to $70 Hourly
  • Full-Time
  • Benefits: Vision, Medical, 401k, Dental

Yoh Life Sciences is looking for a Quality Sr. Manager, Gene Therapy for a large pharmaceutical client in the Boston area! ​

General position summary:

The Senior Manager is responsible for support and quality oversight for the assigned programs focused on Gene Therapy/ Biologics and possesses a strong knowledge of GCP study oversight and management of quality activities related to clinical trial execution and GMP cell-based production (drug development).

The Senior Manager is knowledgeable in the principles and application of quality and regulatory compliance with significant knowledge of regulations applicable to Gene Therapy across the GCP/GMP areas.

Position may require up to 10% national/international travel.

Key RESPONSIBILITIES:

The responsibilities of this position may include, but are not limited to, the following:

  • Provide strategic GCP quality compliance, oversight, and consultation supporting the Gene Therapy program
  • Provide regulatory compliance support & guidance to cross functional study teams
  • Ensure compliance with study protocol and study related procedures/ processes
  • GCP review and approval of applicable procedures (internal, external business partners and vendors)
  • Drive investigations to closure, facilitating root cause analysis and the development of effective CAPA plans
  • Participate in protocol deviation reviews
  • Support deployment of Quality Management System
  • Risk identification and communication
  • May participate on process improvement initiatives
  • Identify and perform KPI/ Metric analysis
  • Engage in preparation, support and follow-up activities related to Inspection Readiness
  • Review changes to applicable global regulations/ guidances and participate on cross functional team to assess impact to Quality Management System
  • Provide cross-functional support across QA as needed (e.g., Vendor Oversight, Audit and Inspection Management, etc.)

Minimum qualifications:

  • Master’s degree and 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 5-8 years of relevant work experience, or relevant comparable background
  • Experience/knowledge of biologics and/or gene therapy regulations and products
  • ICH E6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary; best practices and industry standards

Preferred Qualifications:

  • In-depth Gene Therapy Quality experience across GCP and GMP areas
  • Event Management process and requirements, including CAPA and Effectiveness Checks
  • Root Cause Analysis and Investigation process, tools, and techniques
  • Risk management principles and process, change management
  • Ability to provide GCP compliance interpretation, consultation, training and other supportive services to study execution team
  • Adaptability/ flexibility
  • Analytical thinking/ Data Analysis
  • Attention to detail
  • Communication, presentation and facilitation skills across all organizational levels
  • Strategic/ critical thinking, risk based decision making and problem solving skills

Yoh Enterprise

Why Work Here?

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK

What’s In It For You? We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Medical, Dental & Vision Benefits 401K Retirement Saving Plan Life & Disability Insurance Direct Deposit & weekly ePayroll Employee Discount Programs Referral Bonus Programs Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here! Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

Address

Boston, MA
USA

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