Clinical Quality Specialist (GCP & GVP)
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania
- Salary
- Salary not provided
- Closing date
- Feb 16, 2022
View more
- Discipline
- Other, Manufacturing/QA/QC
- Organization Type
- All Industry, Biotech
Job Details
- 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
- 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
- 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)
- 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
- 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.
Nearest Major Market: Philadelphia
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.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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