Share this Job

Quality Assurance Lead-EU/UK Operations and Qualified Person (QP)

Date: Aug 14, 2019

Location: Remote, C, IE

Company: Spark Therapeutics

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 Quality Assurance Lead – EU/UK Operations and Qualified Person will report directly to the Head of Quality Assurance and be responsible for assuring consistent quality of production by developing and enforcing Current Good Manufacturing Practice (CGMP) systems to meet the requirements of US and EU regulations and guidelines.  The incumbent will be responsible for the QP oversight and release of commercial and clinical products as required by the Regulations.  They will be responsible for interacting with the QA Operations, QA Compliance and QA GLP / GCP Leads ensure robust Quality Systems are established and maintained and are compliant with EU Regulations and Directives.

Responsibilities

Formulate, establish and maintain policies and procedures and accompanying Quality Systems in compliance with EU / UK and US GMP Regulations

Works with QA Operations Lead to coordinate and provide oversight of lot release for bulk drug, drug product and packaged product for clinical and commercial use.  Ensures timely management of batch record review, resolution of deviations/non-conformances, review and approval of in-process and lot release testing records, issuance of Certificates of Conformance and Certificates if Analysis

Apprise senior management of critical issues

Works closely with QA Operations Lead, QA Compliance Lead and QA Clinical Leads in supporting EU/UK/ROW related activities as needed including but not limited to auditing, oversight of contractors, QP lot release activities, training on EU/UK Regulations and Directives

Maintain an in-depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to Quality System activities

Requirements

Education

  • BSc in Biology or Chemistry; MSc preferred
  • 10-15 Years industrial experience in Pharmaceutical Industry with focus on biologics products
  • Demonstrated record of maintaining current with industry practices through the enrollment in continuing education seminars and courses
  • Eligible Qualified Person under the provisions of Directives 2001/83/EC and 2001/82/EC
  • Thorough knowledge of ICH E6 (R2) and Directive 2001/20/EC

 

Experience

  • Previous experience working with products registered globally required
  • Experience in the QP release and distribution oversight of EMA approved products and IMP’s
  • Thorough knowledge of implementing Risk Based approach to Quality Systems and the associated risk assessment tools as per ICH Q9
  • Previous experience auditing of contract manufacturers and testing labs and suppliers
  • Experience in providing QP Certifications for relevant filings in EU
  • Knowledge of analytical techniques associated with biologics
  • Must be knowledgeable and capable in the following areas:
    • cGMP and FDA/EMA biologics, cellular and human gene therapy regulations preferred but not required
    • Aseptic Processing regulations and guidelines 
    • Production of human gene therapy products preferred but not required
    • Process and analytical validation
    • Batch record review and product disposition, change management, document control, deviations management, training, record keeping and CAPA
Competencies
  • Broad knowledge of Quality System implementation and maintenance consistent with EU / UK / US CGMP and CGCP Regulations
  • Ability to work remotely i.e. based in EU while majority of peers are based in US
  • Strong analysis and problem-solving skills
  • Ability to lead cross functional teams in problem resolution
  • Ability to work in a dynamic, fast paced environment with shifting priorities