Clinical Quality Specialist (GCP & GVP)

Location
Pennsylvania
Salary
Salary not provided
Posted
November 12 2021
Ref
812339900
Organization Type
Biotech

Primary Duties:

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.

In coordination with the Clinical Quality team, this is an individual contributor role will implement and optimize Spark Therapeutics’ risk-based quality strategy employing a solution-oriented approach to quality management, quality partnership, quality improvement, and quality excellence.

This role will be supporting quality strategy for Spark Therapeutics’ gene therapy assets as well as supporting 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:

Support the implementation of the GCP / GVP quality strategy for Spark Therapeutics’ gene therapy assets in coordination with Clinical Quality leadership:

  • 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
  • Support proactive inspection readiness activities
  • Support responses to regulators, review boards, ethics committees, development partners, etc.
  • Implement 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
  • Support other quality management efforts, as assigned
Supporting the fit for purpose clinical QMS strategy in coordination with Clinical Quality leadership:

  • Steer, review, deliver, and confirm role-based training plans
  • Support 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
  • Draft, implement, and enhance written procedures to support the clinical QMS
  • 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)
  • Support other quality improvement efforts, as assigned

Education and Experience Requirements:

  • Generally, has 5 years of relevant experience; preferably with 2 years of GCP and/or GVP quality experience
  • Understanding of GCP Principles (e.g., ICH GCP E6 R2; 21 CFR parts 11, 50, 54, 56, 312, 314; European Union Clinical Trials Directive)
  • Awareness of GVP Principles (e.g., European Union Directive 2010/84/EU and current modules)
  • Awareness of global clinical and safety regulations
  • Awareness 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 guide quality activities
  • Experience maintaining and/or 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, supporting, and/or conducting GCP and/or GVP audits
  • Experience or desire to use technology to support quality improvement
  • Experience completing review of regulatory documents
  • Experience drafting, reviewing, implementing, and/or optimizing operating procedures and/or associated training plans
  • Awareness of global regulatory inspection process
  • Ability to partner with cross-functional teams
  • Ability to manage multiple simultaneous projects
  • Structured written and verbal communication skills
  • Commitment to diversity, equity, and inclusion
  • Commitment to continuous learning and development

Complexity and Problem Solving:

  • Working with Clinical Quality Leadership to identify and assess GCP / GVP risks and use 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
  • Identifying and presenting objective quality assessments based on quality and/or regulatory requirements
  • Working with Clinical Quality Leadership to anticipate possible challenges with proposed and/or current people, process, and/or technical approaches
  • Understanding how traditional quality assurance tactics can support building a strong clinical QMS and culture of quality
  • Championing quality with internal and external stakeholders

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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.



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.

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