The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta’s Gene Therapy pipeline. The Data Manager will be responsible for oversight and review of release and stability data, technical reports (analytical method validation and qualification reports) for activities conducted internally. The QC Data Manager will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. The Data Manager will build and oversee a team of four to six QC data reviewers responsible for data generated but are not limited to: aseptic cell culture, relative potency testing, infectious titer testing, replication competent vector assays, qPCR, RT-qPCR, ddPCR, and/or digital PCR and sequencing (Sanger and NGS). The QC Data Manager will work with GT QC ADs and QC-Operations teams to guarantee the timely closure of quality events (Deviations and Lab investigations) and timely delivery and authorization of test data. The QC Data Manager will also work with QA Operations to ensure timely approval of Certificate of Analysis, Certificate of testing and technical reports. All aspects of this position involve working in a GMP compliant manner. This position requires work on site at our Andover, MA facility.

• Review gene therapy product release and stability data generated internally at Sarepta.
• Generate product release Certificate of Testing (CoT) and associated GMP documentation.
• Author and review Quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
• Support review of test methods, development reports, study protocols, and validation reports data and reports.
• Trend data for qualified materials, release products, and stability products
• Review scientific literature for incorporation into technical reports and laboratory investigations.
• Experience in general laboratory experimentation and the use of electronic notebooks.
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), familiarity with cGMP quality systems – Veeva, LIMS.
• Perform other related duties incidental to the work described.
• Manage up to six direct reports.

• BS degree in a scientific discipline with 5-8 years of related experience. MA/MS degree with 4+ years of related experience preferred.
• Working experience in a cGMP environment is preferred.
• Experience with Advanced Therapeutic Medicinal Products (ATMPs, gene therapies) is highly desired.
• Understanding of relative potency assays, infectious titer assays, and replication competent vector assays is highly desired.
• An understanding of PCR, qPCR, ddPCR, and DNA sequencing (Sanger and NGS) is highly desired.
• An understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to bioassays, nucleic acids data review and method qualification/validation is necessary.
• Attention to detail with exceptional and demonstrable record keeping / documentation skills.
• Project management skills including the ability to manage one’s project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
• Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
• Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
• Extensive technical writing skills. Experience drafting GMP SOPs, protocols and reports.
• Operate as a part of a team with experience supervising and or training individuals in a functional, safe working environment while maximizing efficiency.

#LI-Onsite The targeted salary range for this position is $112,000 - $140,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.