Clinical Quality Assurance Lead

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

Summary

The Clinical Quality Assurance (CQA) Lead will report directly to the Head of Quality Assurance and will be responsible for developing and leading the CQA and Global Pharmacovigilance (GPV) Quality Assurance teams that will drive the GCP, and GPV Quality Framework.  The Clinical and GPV Quality Assurance Lead will support and provide Quality oversight of clinical development and pharmacovigilance activities.  The incumbent will provide assurance to the company that clinical studies, and pharmacovigilance are following all applicable regulatory requirements (US/EU/ROW), company policies/ SOPs, and GCP/ GVP guidelines. The incumbent will be responsible for developing, improving and maintaining Phase Appropriate Quality processes and procedures for these activities. The incumbent will be recruiting, developing, and leading a team of CQA and PV quality professionals.

 

 

Responsibilities

10%  Serve as the primary contact in QA for the oversight of Clinical Studies in US, EU and ROW to ensure compliance with all GCP’s from manufacturing, labeling, distribution and site qualification to ensure  compliance with all Regulatory requirements in the country the study is conducted

10%  Liaise with the Head of Clinical, Medical Affairs and Regulatory as needed for the Clinical studies

10%  Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies

10%  Establish/, maintain phase appropriate Quality Systems for clinical studies as well as pharmacovigilance

10% Serve as the primary contact for all Regulatory inspections related to Spark sponsored Clinical, and PV activities.   This includes on site at Spark and remote sites

10%  Ensure robust auditing procedures and practices are in place for GCP, and GPV activities.  Manage/Direct contract auditing services / CRO’s as needed

10%  Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP, and GPV QA activities

30%  Effectively recruit, retain, develop, and lead a team of professionals

 

Requirements

  • Minimum BA/BS in a life science or similar scientific discipline (advanced degree preferred)
  • A minimum of 10 years’ biotech/pharmaceutical experience with 5+ years’ experience in CQA, and GPV activities
  • Experience with QA oversight of multiple clinical studies being conducted simultaneously in US, EU and ROW
  • Experience with senior level interactions and influence with Clinical, Regulatory and Medical Affairs functions.
  • Experience in working in a matrix organization and challenging self and others to continuously learn and improve

 

 

Competencies

  • Strong leadership and communication skills with special emphasis om collaboration skills
  • Excellent interpersonal skills, including written and verbal communication
  • Ability to motivate, develop, and inspire his/her team members and direct reports
  • Strong sense of ethics, diplomacy, discretion, and a commitment to Quality
  • Excellent team player attitude
  • Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • Ability to manage competing priorities
  • Excellent verbal and writing skills
  • Ability to interact effectively with Health Authorities and various Spark stakeholders
  • Must be willing to travel (domestic and international): Up to 20%
Posted
11/04/2020
Salary Range
$74,000.00 - 110,000.00
per Year
Salary range estimated by
Location
Philadelphia, PA 19019, US