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 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.
Define, implement, and optimize the GCP / GVP quality strategy for Spark Therapeutics’ gene therapy assets:
Define, implement, and optimize the fit for purpose clinical QMS strategy:
- 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
Education and Experience Requirements:
- 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
Key Skills, Abilities, and Competencies:
- Minimum 8 years of GCP and/or GVP quality experience
- Strong understanding of GCP (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive)
- 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)
Complexity and Problem Solving:
- Experience assessing risk and using the assessment to tailor quality activities
- Experience designing, 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 planning and conducting GCP and/or GVP audits
- Experience using technology to support quality improvement
- Experience completing quality review of regulatory documents
- Experience drafting, reviewing, implementing, and optimizing operating procedures and associated training plans
- Experience with global regulatory inspections
- 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
- Identifying and assessing GCP/GVP risks and using the determination to guide daily work
- Escalating high impact considerations to Clinical Quality, cross-functional stakeholders, and management
- Ability to apply quality and regulatory knowledge to Development and QMS challenges
- Clearly identifying, presenting, and managing objective quality assessments based on quality and/or regulatory requirements
- Anticipating challenges and mitigation/management of proposed and/or current people, process, and/or technical approaches
- Tailoring traditional quality assurance tactics to build a strong clinical QMS and culture of quality
- Championing quality with internal and external stakeholders
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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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.