The Quality Assurance GCP/GLP Leadwill report directly to the Head of Quality Assurance and will be responsible to ensure the Quality and Compliance of Spark sponsored clinical trials and Spark sponsored GLP studies with respect to Spark Policies and Standard Operating Procedures, applicable Regulatory Requirements (FDA, EU, ICH, country specific and current industry standards and practices). The Lead will also be responsible for developing and leading the Quality Assurance GCP and GLP team that will drive the GCP, GVP, and GLP Quality Framework. The Quality Assurance GCP Lead will:
Support clinical development and pharmacovigilance activities, providing assurance that clinical studies and pharmacovigilance activities follow all applicable regulatory requirements for US, EU and ROW.
Write/review/direct the creation and/or revision of QA policies/SOPs associated with GCP/GVP activities and ensure the documents are compliant with applicable regulations.
Audit GLP activities to ensure the studies are conducted according to applicable GLP regulations and Study protocols.
Provide appropriate level of QA oversight and direction to Pre-Clinical Operations (PCO), Analytical and Bioanalytical activities.
Work with cross functional Leads in Clinical, PCO, QC, Analytical and Bioanalytical Operational Teams to establish recommended QA oversight and Guidelines.
Drive the direction, development, implementation and execution of a GCP/ GVP and GLP Quality Framework, pre-clinical / clinical development and pharmacovigilance processes, systems, tools, training, etc.
Liaise and align with other applicable GXP (e.g. GMP, GDP, GLP, etc.) Quality Assurance teams to ensure coordination and compliance with overall Spark Quality Systems.
20% GCP/ GVP / GLP Compliance Support
Initiate and drive compliance support of the clinical teams and pharmacovigilance activities through GCP/ GVP and GLP quality/ process related consultancy, advice and training.
Develop, track and report compliance metrics.
20% GCP / GVP and GLP Audit Program
Direct and oversee a comprehensive GCP/GVP and GLP Audit Program.
Direct the conduct of audits of clinical development projects, pharmacovigilance activities and other applicable GXP Systems through Spark and/or contact resources to ensure regulatory compliance and/ or successful license applications.
20% GCP and GVP Regulatory Authority Inspection Support
Serves as the Lead in the coordination, preparation for and management of GCP/ GVP related inspections by Regulatory Authorities (including pre-inspection activities as well as follow-up activities). Communicates to senior management of critical issues, coordinates the preparation of data trending metrics for reporting into Sr Management. Interact with clinical development and pharmacovigilance teams to promote continuous improvement programs through the analysis of these data.
20% CQA Infrastructure
Responsible for the maintenance and continued process improvements and operational excellence of CQA Standard Operating Procedures and Policies.
Direct appropriate resourcing budget development and budget management within CQA by strategic assessment of workload, required planning for staffing, coordination of consultant activities as needed and on-going review of forecasted expenditures. Ensure appropriate allocation and utilization of Global CQA resources.
Manage GCP QA team members to ensure efficient and effective QA operations and that QA initiatives are consistent with and advance company objectives within approved budgets.
Hires and manages a QA team; providing direction and alignment to corporate and departmental goals. Provides continues feedback.
Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP Quality Assurance activities.
Strong leadership and communication skills with special emphasis on collaboration skills. Ability to manage a team in a globally dispersed department.
Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions.
Very good interpersonal skills, i.e. ability to build constructive relationships across all levels of the organization, positive & constructive attitude, and ability to work in interdisciplinary teams.
Very good prioritization, organizational, communication, and negotiating skills
Very good written and verbal communication skills in English
Ability to motivate, develop, and inspire his/ her team members and direct reports.
Good computer skills
Minimum Bachelor’s Degree in Scientific Discipline/ Life Sciences or related disciplines
Minimum 15+ years of pharmaceutical/biotech industry experience with
5+ years experience in Clinical Quality Assurance and at least 5 years GCP and/or GVP auditing experience with a global company or Clinical Research Organization
3-5 years experience in QA oversight of GLP activities
Demonstrated experience with implementation of Quality Systems for Pre-Clinical/Analytical Development and Bioanalytical activities including method validation
Minimum 5 years of Management/Supervisory experience is required.
Very good knowledge of Good Clinical and Pharmacovigilance Practices, quality systems, and GXP auditing required in US, EU, ROW
Good expertise in GLP with US GLP regulations and guidelines with the ability to understand and interpret applicable local / EU / ROW regulations
About Spark Therapeutics
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.