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 unlock the power of gene therapy to accelerate healthcare transformation.

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

The Clinical Quality team focuses on understanding the evolving regulatory landscape to build and enhance fit for purpose quality foundations that enable Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP) excellence. The Clinical Quality team strives to ensure that the clinical quality management system (cQMS) is optimized to foster a culture where quality innovation matches Spark Therapeutics' cutting-edge and patient-centric science.

This is an individual contributor role responsible for assisting in the development, implementation and maintenance of QA systems and activities supporting GCP and PV operations. This includes audits, vendor oversight, training and clinical study team(s) support.

Responsibilities

• Assist in the development of internal processes and systems related to GCP and PV QA activities.
• Support the development and management of the CQA audit program for the assigned projects and compliance areas, including timely execution, reporting, follow-up and closure.
• Participate in self-inspections/audits of internal processes/ procedures, clinical investigator sites, clinical databases, study reports, contract CROs/vendors, and/or Independent Ethics Committees/ Institutional Review Boards to assess the accuracy and quality of scientific data and/or ensure compliance with relevant guidelines, legal requirements and GxPs.
• Manage CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated (including risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed and closed promptly.
• Provide global GCP and GVP guidance for cross-functional development teams inclusive of the review of critical documents (e.g., study protocols, investigator’s brochure, periodic reports).
• Contribute to ongoing inspection readiness/preparation activities and participate in management and facilitation of regulatory inspections.
• Interface with training system administrator to ensure learning management system (LMS) is fit for clinical development use.
• Track and manage periodic management reports including key Clinical and PV Compliance and QA metrics.
• Support the development and continuous improvement of the Spark Quality System (tools, e-Systems.)
  
  
  

Requirements

• BS/BA degree in life sciences or other related discipline
• Minimum of 5 years of professional work experience in clinical research in the pharmaceutical industry; minimum of 3 years’ experience in clinical (GCP/GVP) quality assurance.
• Good understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Regulation)
• Understanding of GVP (e.g., European Union Directive 2010/84/EU and current modules) is a plus.
• Understanding of the clinical development lifecycle (ideally for cell and/or gene therapies or other advanced therapy medicinal products)
  
  
  

Key Skills, Abilities, And Competencies

• Experience assessing risk and using the assessment to tailor quality activities
• Experience maintaining and optimizing quality management systems; Desire to employ quality by design principles to optimize quality
• Experience managing the issue/risk lifecycle (e.g., identify, evaluate, escalate, manage, close, effectiveness check)
• Experience or desire to use technology to support quality improvement
• Experience completing quality review of regulatory documents
• Experience drafting, reviewing, implementing, and optimizing operating procedures and associated training plans
• Understanding of global regulatory inspection process
• Ability to partner with cross-functional teams
• Ability to manage multiple simultaneous projects
• Structured written and verbal communication
• Commitment to diversity, equity, and inclusion
• Commitment to continuous learning and development
  
  
  

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $120,700-$181,100.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.