Quality and Compliance Expert
As a Quality and Compliance Expert, you will play a critical role in ensuring the highest standards of quality and compliance in manufacturing and testing operations. This is an exciting opportunity to be part of a global network dedicated to delivering reliable and compliant products to customers and patients.
Your Responsibilities
- Provide quality oversight for external entities manufacturing or testing cell banks, biologic drug intermediates, substances, or products.
- Ensure products comply with policies, procedures, and regulations before further processing.
- Oversee quality control functions, including product testing, batch documentation review, and deviation investigations.
- Manage transfers, including due diligence, feasibility studies, protocols/reports, PPQ, PAI readiness, and quality system oversight implementation.
- Ensure audit readiness, support regulatory inspections, and manage complaints effectively.
- Oversee change control, conduct metric reviews, and perform annual product reviews.
- Build effective quality systems at external entities and drive continuous improvement initiatives.
- Exhibit leadership behaviors and set a leadership example for the team.
- Maintain compliance with established policies/procedures and all applicable governmental regulations, both domestic and foreign.
About You
You are ready if you have:
- A bachelor's or master's degree in science, engineering, or a related field.
- Eight years of relevant experience in the pharmaceutical/biotechnology industry with knowledge of quality systems, quality assurance, and quality control, including global GMP and regulatory requirements.
- Experience with manufacturing operations and/or analytical expertise in biologics and/or vaccines, including aseptic manufacturing.
- Competence in analyzing complex product, production, and testing issues with demonstrated scientific problem-solving capabilities.
- Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills.
- Ability to work independently with minimal guidance and proficient in verbal and written communication in English.
Nice to Have
- Direct experience managing external partners (CMOs, labs, etc.).
- Experience in batch disposition, deviation management, change control, and participating in regulatory inspections.
- Knowledge of compliance regulations and standards in regions outside of Europe, such as North America, Asia-Pacific, Latin America, or other relevant markets.
This role involves remote work in Ireland, Switzerland, or Spain with occasional travel outside of the EU. You must be based in one of these countries for your application to be considered.