Senior Specialist, Quality Assurance
Provide Quality review for external production and testing activities for clinical trial material. Review and assess deviations, including risk assessments, participate in root cause analysis investigations, tracking and follow ups. Review and approval of analytical testing protocols, methods and validation report. Work cross functionally to ensure all regulatory requirements are met with regards to the production and testing clinical trial materials as well as the oversight of third parties. Participate in Site Visits and/or Quality audits for CMOs and CTLs as needed. Review of Qualification activities for CMOs and CTLs. Ensure Quality Agreements are followed for contracted activities. Coordinate disposition activities for investigational products by review of executed batch records, deviations, COA and all associated disposition documents for clarity, completeness, compliance with cGMP and conformance to Product Specification. Support review of regulatory filing activities as needed. Establish and maintain internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations. Participate in Health Authority inspections by collecting and presenting documents requested and scribing conversations. Represent Quality at internal and external project team meetings as needed by presenting status updates on QA activities. Communicate with CMOs and Contract Laboratories by defining PepGen requirements and timelines.
Experience and Education include, but are not limited to:
- Bachelor’s Degree in Biomedical Engineering or Pharmacy
- 36 months of experience Quality Assurance in pharmaceutical/biotech environment
Location
321 Harrison Ave, Floor 8, Boston, MA 02118
Hours/Salary
Minimum of 40 Hours / Week at $110,000 per year
Send CV to PepGen, Attn: Ms. Bryant, 321 Harrison Ave, 8th Floor, Boston, MA 02118. PepGen is an Equal Opportunity Employer.
About PepGen
PepGen is a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.
For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.
EEO Statement
PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
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