Associate Director, Clinical QA

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 (QMS) is optimized to foster a culture where quality innovation that matches Spark Therapeutics' cutting-edge and patient-centric science.

This is an individual contributor role with the potential for management (direct reports) that will define, implement, and optimize risk-based quality strategy in coordination with the Clinical Quality team employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence.

This role will be defining, implementing, and optimizing quality strategy for Spark Therapeutics’ gene therapy assets as well as leading efforts to enhance the fit for purpose QMS in line with GCP and GVP best practices that adds value to novel therapy development.  Joining Spark Therapeutics during a growth phase, this role will be essential to scale Spark Therapeutics’ Clinical Quality foundations.

RESPONSIBILITIES

50% of time- Define, implement, and optimize the GCP / GVP quality strategy for Spark Therapeutics’ gene therapy assets:

• Define, implement, and optimize risk-based quality management plans for clinical assets
• 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)
• Support issue management and corrective/preventive action management activities within Spark Therapeutics as well as with external service providers
• Lead proactive inspection readiness activities globally, Support questions from regulators, review boards, ethics committees, development partners, etc.
• Design and oversee risk-based audit plans which may include but are not limited to clinical investigator audits and vendor audits; Conduct and/or oversee audits in accordance with audits plans
• Lead and support other quality management efforts, as assigned

50% of time- Define, implement, and optimize the fit for purpose clinical QMS strategy:

• Plan and conduct efforts to evaluate and improve the clinical QMS inclusive of reporting to leadership stakeholders (e.g., QMS health metrics, prioritized QMS initiatives, internal audits)
• Partner with functional departments (e.g., Biometrics, Clinical Operations, Clinical Development, Safety) to enhance Spark Therapeutics’ culture of quality
• Monitor global trends and engage with industry stakeholders to enable quality excellence
• Draft, implement, and enhance written procedures to support the clinical QMS
• Steer, review, deliver, and confirm role-based training plans
• Support efforts to identify and implement new technologies to optimize quality (e.g., electronic QMS, electronic trial master file, clinical trial management system, safety tools, learning management system)
• Lead and support other quality improvement efforts, as support

REQUIREMENTS

• 10 years of GCP and quality experience (GVP quality experience preferred but not required)
• Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive)
• General understanding of GVP (e.g., European Union Directive 2010/84/EU and current modules)
• Understanding of global clinical and safety regulations   
• Understanding of the clinical development lifecycle (ideally for cell and/or gene therapies or other advanced therapy medicinal products)

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 $143,600-$215,400.

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.