Professional Summary
Professional Overview
Eva Moloney is a seasoned Quality Executive with extensive experience in external manufacturing (CMO) quality compliance within the pharmaceutical industry. She specializes in ensuring the quality and regulatory compliance of contract manufacturing operations, playing a pivotal role in maintaining the high standards expected by major pharmaceutical companies.
Experience Summary
Current Role
As the Quality Executive - External Manufacturing (CMO) Quality Compliance at Helsinn Group, Eva is responsible for overseeing the quality and compliance of the company's contract manufacturing partners. In this role, she collaborates closely with CMOs to implement robust quality systems, conduct audits, and manage regulatory submissions to ensure Helsinn's products meet all applicable standards and regulations.
Career Progression
Prior to her current position, Eva held various quality-focused roles at esteemed pharmaceutical companies, including Sebela Pharmaceuticals, Aspen Pharma, and Takeda Ireland Limited. Her career progression demonstrates a steadfast commitment to quality assurance, process compliance, and regulatory affairs within the industry.
At Sebela Pharmaceuticals, Eva served as a Quality Specialist, where she played a pivotal role in maintaining quality systems and supporting regulatory compliance efforts. Her expertise in quality assurance and regulatory affairs was further honed during her time as a Quality Analyst at Aspen Pharma and a Quality Assurance Analyst (Operational Compliance) at Takeda Ireland Limited.
Academic Background
Eva holds a strong academic background, having attained a Bachelor's degree in Pharmaceutical Technology from a reputable institution. Her specialized education has provided her with a deep understanding of the technical and regulatory aspects of the pharmaceutical industry.
Areas of Expertise
- External manufacturing quality compliance
- Quality system implementation and management
- Regulatory affairs and submissions
- Pharmaceutical manufacturing processes
- Quality auditing and risk management
- Collaboration with contract manufacturing partners
Professional Impact
Throughout her career, Eva has demonstrated a proven track record of driving quality and compliance initiatives that have positively impacted the operations of her employer organizations. Her attention to detail, problem-solving skills, and collaborative approach have enabled her to successfully navigate complex quality-related challenges and contribute to the overall success of the companies she has served.
Conclusion
With her extensive experience in external manufacturing quality compliance and a strong academic foundation, Eva Moloney is a valuable asset to the pharmaceutical industry. Her dedication to maintaining the highest standards of quality and regulatory compliance makes her a trusted professional in her field.
