Executive Director of Quality Assurance

Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion.

Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of multiple first-ever disease treatments at speeds faster than industry average.

As a result of the rapid expansion of their Biologic, mRNA and Gene-Therapy portfolios we are seeking an Executive Director of Quality Assurance who will play a key role in continued development and eventual commercialisation of their products. This role is on a permanent basis located in Basel, with flexibility to work from home.

**Responsibilities**:

- Progress, and lead the Quality Assurance team that manages batch disposition and health authority communications for quality matters in the EU.
- Collaborate with Quality Compliance, CMC QA, QC, Technical Operations, Regulatory Affairs, Commercial and Supply chain organizations to ensure uninterrupted, safe, and efficacious product supply that meets patient and regulator expectations.
- Arrange resources to develop, negotiate, and manage quality agreements. Ensure effective execution of Quality Technical Agreements.
- Implement and preserve the company's Quality System in EU
- Represent the company during inspections and/or discussions with health authorities.
- Qualified Person (QP) in the European Economic Area (EEA) in the Netherlands for the company Netherlands B.V.
- Responsible Person (RP) in Switzerland for the company Europe GmbH.
- Accountable Person (GDP-RP) in the Netherlands and Germany.
- Confirm development of quality metrics that predict the performance and health of the quality systems and processes.
- Ensure completeness of technical evaluation and quality due diligence activities as required.
- Collaborate with CMC Leads and Portfolio Management partners to ensure successful planning, execution and delivery of projects.
- Guarantee activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices.
- Partake in external collaborations to influence policy, practices and current guidance for the manufacture of biologics, small molecules and novel therapeutics.
**Skills & Requirements**:

- Registered as QP or Swiss Responsible Person or ability to fulfil legal requirements (education, knowledge, experience) to get registered as EU QP or Swiss RP. Experience managing quality decisions and release decisions for commercial and clinical products.
- Experience across several modalities including small molecule, biologic, and advanced therapeutic (gene therapy, mRNA) products.
- A Master's degree or equivalent in a scientific discipline (Pharmacy, Biology, Chemistry, Biochemistry) required.
- At least 15+ years of experience in pharmaceutical / medical device industry.
- At least 10 years of experience in a Quality Organization in a CBER/CDER regulated industry.
- At least 10+ years of experience leading and developing teams.
- Knowledge in product lifecycle management.
- Prove quality mindset and ability to effectively collaborate and influence across the entire organisation.
- Capacity to manage budget and resourcing and to lead a department.
- Proficient knowledge of cGMPs, with a focus on knowledge of Swiss and EU laws and ordinances.
- Knowledge and experience negotiating quality agreements and managing vendor relationships and performance.
- Resourcefulness to develop quality processes that fit virtual DS and DP product manufacturing operations for biologics, small molecules, and novel therapeutics.
Robust interpersonal skills and the ability to work well as part of a team.
- Exceptional verbal and written communication skills.
- Proficient in risk assessment and root cause analysis tools.
- Able to travel to vendor sites as well as work on site at the company offices in Switzerland, Germany, and Netherlands as required and as COVID regulations allow.
- May be required to travel up to 10% of the time to company offices outside the EU region as COVID regulations allow.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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