Director QA, Therapeutic Area Quality Lead - US or Canada (Remote)

Multiple Locations: California, United States • North Carolina, United States • New Jersey, United States • Illinois, United States • Massachusetts, United States • Pennsylvania, United States

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Requisition Number: 2400

Position Title: Director-Therapeutic Area Quality Lead QA Clinical Oversight Program

External Description:

SUMMARY:          Responsible for Oversight of Worldwide’s Quality Assurance Clinical Oversight Program – Morrisville, NC Office
 
This individual is responsible for the Strategic Vision, oversight, planning, execution, reporting and quality management of the QA Clinical Oversight Program
 
RESPONSIBILITIES:

  • This individual reports directly to the VP Global Head of Quality
  • Strategic planning, oversight, delivery, maintenance, reporting and follow up of QA Clinical Oversight Program
  • Serves as the QA point person for Clients
  • Liaisons with Client QA partners
  • Develops and executes on Quality Agreements as applicable
  • Attends Client meetings as necessary
  • Assigns QA auditors as Leads to Clinical Programs based on therapeutic areas
  • Works collaboratively with the Therapeutic Area Leads (TALs)
  • Participates in Protocol Risk Assessments as necessary
  • Defines and generates quality metrics for the Program
  • Defines the SOPs for the QA Audit Program and participates in biennial reviews
  • Serves as a Subject Matter Expert on QA SOPs
  • Oversees the investigational of quality issues and follow up of all CAPAs that occur in the clinical programs
  • Ensures document management in accordance with the Quality Management System
  • Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

 
OTHER SKILLS AND ABILITIES:

  • Communications professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
  • Acts with authority, and drives performance and accountability
  • Ability to lead a team of individuals with a clear vision and defined purpose
  • Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
  • Ability to speak, read and write English fluently
  • Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
  • Excellent understanding of clinical research principles and processes for clinical trials
  • Excellent Leader but also has demonstrated ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators
  • Demonstrated ability to conduct varus types of GCP audits inclusive of Clinical Investigator Audits, Trial Master File Audits, Clinical Study Report Audits, Vendor Audits, Marketing Application Audits, and Database Audits)
  • Demonstrated ability to implemented risk management strategies

 
REQUIREMENTS:

  • Working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
  • Excellent understanding of the Drug Development Process
  • Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES)
  • M.S. in a scientific or allied health filed and  7+ years of relevant GCP, GLP, GVP experience
  •  
  • Four-year college curriculum with concentration in biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP, GLP, GVP experience
  • Domestic and international travel required (approximately 30%)

 
#L1-RL1 #L1-Remote #IND-RL1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Director QA, Therapeutic Area Quality Lead - US or Canada (Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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