QA Manager, CMC Development - Job ID: 1165
Emma highlights
This highlight was written by Emma’s AI. Ask Emma to edit it.
Full-time
Compensation
USD145k - 160k/year
Posted about 3 years ago
Responsibilities
Ascendis Pharma is a leading and fast-growing biotech company focused on developing best-in-class therapeutics for rare diseases. They are committed to supporting personal development and are on a journey to become a leading rare disease company.
Join the QA Development Team in a leading and fast-growing biotech company. Ascendis Pharma is expanding its QA Development team to support the increasing CMC development activities within the Endocrinology and Oncology pipelines. As a QA Development Lead, you will work closely with the CMC Development team in Redwood City and the Development QA Team in Copenhagen to ensure compliance with Ascendis Pharma's Quality Management System. Your responsibilities will include ensuring GMP compliance, handling CMO validations and deviations, ensuring quality oversight of CMO-manufactured drug products, and assisting with GMP inspection readiness activities.
Responsibilities:
- Ensure and develop GMP Compliance at the Ascendis Redwood City Site in collaboration with the Ascendis Copenhagen HQ
- Handle CMO validations, deviations, change controls, raw data review, etc.
- Ensure quality oversight of CMO-manufactured drug products
- Apply global regulations, agency guidelines, and internal procedures to ensure compliance
- Assist with CMC and regulatory department fillings (INDs, CTAs)
- Schedule, plan, and prepare CMO, CRO, and/or laboratory for audits
- Communicate audit results to stakeholders
- Assist with GMP inspection readiness activities for regulatory authority inspections
- Develop and implement GxP systems and procedures
- Identify and communicate quality or compliance risks
- Ensure documentation, procedures, and processes supporting development programs are maintained in compliance with company and industry standards
- Maintain working knowledge of current FDA, EU, and other global regulations and guidance governing GMP, Pharmacovigilance, and Good Laboratory Practice activities