Director, Quality Emeac - Zug, Schweiz - Reata Swiss International GmbH

Beschreibung

Join Us | Reata Pharmaceuticals
We are committed to positively impacting the lives of patients with life-threatening diseases.

With rigorous science and research as our foundation, we are a global team of problem solvers, trailblazers, and people who want to make a difference in the lives of patients.

In addition to the US, we have a European office based in Zug, Switzerland.


What You Will Do | Responsibilities

This role will work in close collaboration with our global Quality department and EMEAC team to ensure EMEAC operations compliance with applicable EMEAC Quality regulations and standards.

In this role, you will collaborate with the global Quality team to ensure the implementation of global procedures that are compliant with requirements including those applicable to our Swiss and Irish operations.

This fulfills a key role in the global Quality organization and supports the global supply chain and our broader EU operations in the context of a fast-growing organization preparing for the launch of new medicines.

• Plan, establish, and manage Quality activities supporting GMP and GDP in the EMEA region
• Act collaboratively and constructively on a crossfunctional basis at a global and regional level on ensuring compliance of EMEAC operations with applicable Global and EMEAC Quality regulations and standards, including specifically for our Swiss and Irish operations
• Work closely with the global Quality and EMEAC team to support timely operational and launchreadiness in Europe from a Quality perspective
• Represent Reata during EMEAC regulatory inspections, corporate good manufacturing practices (GMP) compliance audits, and support a culture of continuous improvement
• Perform functions and make decisions consistent with GMPs and GDPs and Reata's Quality governance
• Provide Quality expertise to influence and support compliant decisions across the supply chain
• Support internal audits, external audits of CMO, and inspections at CMOs, as needed
• Ensure Quality Agreements are in place with respective external and internal parties
• Support market withdrawals and product recalls, if necessary
• Manage and perform analytical data review and approval, as needed
• Coordinate the review of Certificates of Analysis and chemistry review of batch records
• Coordinate the review of Quality Issues reported by manufacturing sites
• Assist in investigations and CAPAs
• Partner with the Chemistry, Manufacturing, and Controls department at Reata to ensure personnel, process, documentation, and quality standards meet expectations for regulatory submissions, regulatory authority inspection readiness, and compliance with applicable guidelines
• Foster an environment of collaboration, trust, quality, innovation, and continuous improvement within the quality organization, between other functional departments, and with external stakeholders
• Contribute towards the identification and assessment of quality risks and ensures they are evaluated and managed appropriately to accomplish both business goals and regulatory and quality requirements
• Contribute to the development and administration of budgets, expenditures, and the allocation of resources for various quality projects
• Willing to travel up to 20% of the time
• Other duties performed as needed

Along with a highly developed quality and entrepreneurial mindset
, you will be a leader who is collaborative, strategic, and accountable, delivering results in an ethical and positive manner.

What We Are Looking For | Qualifications**- 10+ years of pharmaceutical industry experience in Europe in roles of increasing responsibility

• Strong working knowledge of EU and Swiss GMP and GDP requirements, and with ICH, FDA, and USP/EU pharmacopeia requirements for drug substance and oral dosage forms
• Experience supporting the successful commercial launch of new drugs in a startup environment
• Comfort interacting with QP, RPs, and responsible authorities in Europe. Prior experience as a QP/RP preferred
• Previous practice in a commercial drug substance or dosage form manufacturing environment
• Experience with small and large molecules required
• Excellent strategic and communication skills with the ability to influence decisions at a senior level, both internally and externally
• Familiarity with common technical document formats

What We Are Looking For | Education**- Minimum BA / BS or equivalent scientific degree is required; an advanced degree is preferred


Location | Travel**- Remote or hybrid

• 20%+ travel
• Reata Pharmaceuticals is an equalopportunity employer committed to creating an inclusive environment for all employees._