Quality Assurance Manager

We are seeking an experienced Quality Assurance Manager to join our Radiopharmaceutical clients team. This role is ideal for a dynamic professional with a strong background in the pharmaceutical, biotech, or CDMO industries. The successful candidate will play a critical role in ensuring compliance with regulatory standards and fostering a culture of quality excellence.

Great opportunity to work in Radiopharmaceuticals and develop your career working with some of the most advanced technologies in the industry!

Key Responsibilities:

• Lead and support onsite FDA inspections and client audits, leveraging prior experience with FDA audits.
• Collaborate with cross-functional teams to develop and implement solutions that address quality challenges proactively.
• Manage and mentor a team of direct reports, providing guidance and support to drive performance and professional growth.

Qualifications:

• A minimum of 5+ years of industry experience in Quality Assurance within the pharmaceutical, biotech, or CDMO sectors. Candidates with QA experience outside these industries will not be considered.
• Strong understanding of 21 CFR 211 and other relevant regulatory requirements.
• Proven ability to confidently represent the organization during FDA inspections and audits.
• Demonstrated leadership experience, including managing direct reports.

Ideal Candidate Attributes:

• A solution-oriented mindset with the ability to think on their feet and act decisively.
• Strong communication skills, confidence, and the ability to inspire trust and credibility.
• Proactive and self-driven, capable of working independently without requiring extensive guidance.

This is an excellent opportunity for a confident, proactive professional to make a significant impact in a high-stakes environment. If you are looking for a chance to excel in your career, we would love to hear from you!