QA/RA Manager

Our client is an innovative pharmaceutical and biotech organisation focused on health and nutrition, developing and marketing products that address and support nutritional deficiencies in patients.

They now require a QA/RA Manager, to join their growing team based out of Dublin, working remotely from the beginning with the flexibility to travel to and from their operations in Milan when required. This is a really exciting role that offers a unique opportunity for someone who is eager to contribute to the early stages of bringing an innovative drug product to market, playing a key part in shaping its success and regulatory approval.

The Position

• Write and review technical documents (development reports, protocols, study reports).
• Author and compile regulatory documents (CMC sections).
• Assist in developing and updating regulatory filings, including master files, technical files for medical devices, and CTDs for drug approvals.
• Establish and maintain a quality management system and document management system.
• Collaborate with cross-functional, international teams for input and feedback.

The Person

• PhD or Master's in science (Chemical Engineering, Chemistry, Bio-Chemistry, Pharmacy, or related field).
• 3+ years of experience in GMP manufacturing or CMC writing.
• Knowledge of CMC processes, including drug substance/product manufacturing, stability, analytical and formulation development.
• Ability to convert technical information into regulatory-compliant documentation.
• Strong communication, planning, and organizational skills.
• Able to manage multiple tasks independently in a fast-paced environment.
• Fluent in English.

The Benefits

• Competitive Market Salary.
• Significant career growth and opportunities.
• Comprehensive benefits package.

To learn more about this opportunity, apply online or contact Treasa Prior at HRM Search Partners at +353 873983226, for a confidential discussion.