The QA Associate Director will work closely with the Development team in Redwood City and the Development QA Team in Copenhagen to support ongoing responsibilities and defined goals by ensuring that activities are in compliance with Ascendis Pharma’s Quality Management System. The QA Associate Director/Director will be responsible for ensuring that development activities are conducted in accordance with EU GMP and US GMP to support the different activities conducted on a global scale. The QA Associate Director/Director will be leading initiatives to ensure process quality consistency at all Ascendis Pharma sites and for ensuring a smooth quality transition for the CMO and CRO partners to Ascendis Pharma.
The key responsibilities are:
- Ensuring and developing GMP Compliance at the Ascendis Redwood City Site in tight collaboration with the Ascendis Copenhagen Site
- CMO responsibility regarding Compliance amp; Quality.
- Apply global regulations, agency guidelines and internal procedures to ensure compliance.
- Schedule, plan and prepare CMO, CRO and/or laboratory for audits. May also audit internal processes, submission documents etc. in accordance with the audit plan or as requested.
- Conduct audits and prepare and submit audit reports for review and input.
- Communicate audit results to stakeholders.
- Assist with GMP inspection readiness activities for regulatory authority inspections and coordinate tracking of document requests, responses, and supporting documentation during inspections.
- Develop and implement GxP systems and procedures including SOPs, policies, forms, and tools such as excel spreadsheets or reports.
- Identify and communicate quality or compliance risks and participate in the development of an appropriate plan to address risks.
- Ensure that documentation, procedures and processes supporting development programs are maintained in compliance with company and industry standards and global regulations.
- Maintain working knowledge of current FDA, EU, and other global regulation and guidance governing Good Manufacturing Practice (GMP), Pharmacovigilance (PV) and Good Laboratory Practice (GLP) activities.
Requirements
- Relevant Academic degree - preferably a Master of Science in Chemistry, Engineering, Pharmacy or the like
- At least 10-12 years of experience in Quality Assurance.
- A minimum of 5 years of experience working with CMOs and CROs.
- Strong quality mindset
- Thorough knowledge of the drug development process (Phase I Phase III)
- Good knowledge of worldwide GxP compliance regulations (EMA and FDA as a minimum)
- Thorough Knowledge within:
- Research and development practices
- Scientific and quality terminology
- Industry standards for quality assurance, quality management procedures, policies, and quality evaluation techniques.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Prior Experience in supporting regulatory submissions such as INDs, CTAs, NDAs and BLAs
- Excellent written and verbal communication.
- Travelling: 20 - 30 days per year
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance