Quality Senior Manager in Boston, MA at APEX Systems

Date Posted: 11/8/2019

Job Snapshot

Job Description

Job #:  1025225

Quality Senior Manager in Boston, MA!
Apex Systems combines with parent company On Assignment to make it the 2nd largest IT staffing agency in the country.
Apex has an opportunity for a Quality Senior Manager role in Boston, MA. This is a 6+month contract position and the pay rate is flexible depending on experience. Here are the details: 
For applicants who are interested in this Quality Senior Manager opportunity; please send a Word resume to technical recruiter Kristina Walkins, kwalkins@apexsystems.com 
Position: Quality Senior Manager
Apex Job ID: 1025225 
Location: Boston, MA
Rate: Negotiable based on experience
Duration: 6+ month
General position summary:
The GCP Quality 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. This role is in an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone who is not afraid to dive in and help develop this expanding team.
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 with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with 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

Nice to haves:
  • 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

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.