**Applicants must live in the greater Philadelphia area. This position will be remote until our Philadelphia site is open**

PRINCIPAL RESPONSIBILITIES:

• Primary supplier quality liaison for clients and internal customers.

• Conduct risk-based supplier audits, evaluations, and assessments.

• Identify and mitigate risks related to supplier quality, including conducting regular risk assessments and developing contingency plans.

• Oversee supplier corrective action records (SCARs), issue supplier complaints, and drive the resolution and corrective action process.

• Maintain Supplier Quality Agreements and questionnaires.

• Perform Quality review and approval of supplier-affected Change Controls.

• Perform statistical evaluations to identify trends and report on Supplier Quality metrics (scorecards) and present metrics during Supplier Business and Quality Review meetings.

• Monitor and communicate changes in regulatory requirements that may impact supplier quality standards and ensure suppliers are updated accordingly.

• Manages onboarding of new suppliers and the Approved supplier list.

• Participate and present supplier quality data in Management Review. Determine next steps for suppliers not meeting supplier scorecard metrics.

• Conduct internal quality audits and develop and assess subsequent corrective action recommendations (as needed).

• Provide support for FDA or other regulatory inspections and customer audits.

• Provide leadership and coordination on assigned projects.

• Ensure a safe and quality working environment through training, awareness and compliance to regulatory guidelines and procedures.

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Collaborate with supply chain, manufacturing and technical teams to identify root causes of supplier related problems and develop appropriate corrective actions for investigations.

• Consult cross-functionally to resolve complex issues, trends, and quality challenges, balancing technical, regulatory, and business requirements.

•Performs other duties as assigned.

QUALIFICATIONS & REQUIREMENTS:

• Bachelor of Science degree in Life Sciences or Engineering required and or equivalent of relevant years of experience in the field required.

• Five (5) + years’ experience of relevant Quality experience in a finished pharmaceutical manufacturing environment with strong understanding of and exposure to applicable quality systems working under ICH Q7, GxPs, 21 CFR 210, 21 CFR 211 and/or 21 CFR 212 regulation required.

• Experience in radiopharmaceutical environment strongly preferred.

• Working knowledge of Supplier Quality Management, Supplier Auditing, Supplier Assessment, Supplier Quality Agreements, and Corrective Action is strongly preferred.

• Must have a working knowledge of cGMP guidelines.

• Must have strong technical knowledge in pharmaceutical quality systems with proficiency in the following: Deviations (Non-compliance), Change Control, Internal Auditing, Corrective Action Program, Exceptions, Out of Specification Investigations, Customer Complaints, Document Management.

• Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation, equipment, processes, and facility systems.

• Must have experience with statistical tools.

• Certification in ASQ preferred (Auditor).

• Excellent/strong communication, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, both internal and external.

• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided by Nucleus or sponsor.

• Highly organized with strong attention to detail and commitment to high quality work.

• Ability to work in a collaborative manner; identify challenges and barriers and recommend resolutions.

• Proficient in use of Microsoft suite of products.

• Knowledge of other quality functions is preferred.

• Ability to travel up to 60% expected as position / company grows.

• Must be willing to travel frequently to suppliers / vendors and to other Nucleus sites as the company grows.

• Must be able to visually discern, distinguish, inspect, assess, and observe quality of product daily.

THE FINE PRINT:

The salary range for this position is $100,000 - $130,000 per year. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.

This job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.

Nucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender

identity, national origin, veteran, or disability status.