Qureos Mentor

Sofie

<div><div>Job Description | Sr. Supplier Quality Manager
Location | Totowa, NJ or Dulles, VA
Department | Quality &amp; Compliance
Reports To | Director, Quality Management NJ5
Training Curriculum ID | TCU.001
Pay Range: $130,000-140,000/yr 
Overview
SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US, operating under both 21 CFR Part 212 (diagnostic manufacturing) and 21 CFR Part 211 and EudraLex Volume 4 (therapeutic manufacturing at NJ5, our Therapeutic Center of Excellence).
The Sr. Supplier Quality Manager provides strategic leadership and oversight of the company-wide Supplier Quality Program, ensuring robust and compliant processes for vendor qualification, monitoring, and continuous improvement across SOFIE&rsquo;s diverse network. This role directly manages the Supplier Quality Manager and serves as the primary Quality lead for supplier-related initiatives across both regulatory frameworks. 
Essential Duties and Responsibilities
Leadership &amp; Management<ul><li>Provide mentorship, coaching, and direct supervision of Supplier Quality Manager(s).</li><li>Serve as the primary corporate authority on supplier quality across SOFIE.</li></ul>
Program Ownership<ul><li>Lead the design, governance, and improvement of SOFIE&rsquo;s Supplier Quality Programs across all 21 CFR 212 sites and NJ5 (21 CFR 211, Eudralex Volume 4, and ROW regulations).</li><li>Harmonize supplier qualification, monitoring, and auditing practices across sites while ensuring sitespecific compliance requirements are met.</li><li>Develop and maintain policies, SOPs, and standards for supplier quality management.</li></ul>
Regulatory &amp; Compliance<ul><li>Ensure all supplier quality systems are fully compliant with FDA regulations, ICH guidelines, and applicable standards.</li><li>Interpret and apply differences between 21 CFR 211 and 212, EU and ROW supplier requirements, tailoring programs accordingly.</li><li>Act as SME during regulatory (FDA, EMEA, etc.) and customer inspections related to supplier management.</li></ul>
Vendor Qualification &amp; Oversight<ul><li>Oversee vendor qualification, auditing, and requalification activities.</li><li>Ensure approved vendor lists and other tracking tools are maintained and current, that individual vendor qualification documents are complete, correct and current, and that vendors are requalified by due date.</li><li>Review and approve Quality Agreements, ensuring alignment across therapeutic and diagnostic programs. Ensure consistency between NDA, master business agreements and Quality Agreement, liaising with SOFIE and partner counsel as needed.</li><li>Lead risk assessments for suppliers and materials, integrating risk-based decision making into the supplier lifecycle.</li></ul>
Quality Systems Integration<ul><li>Drive alignment between supplier quality management and broader Quality Management System (QMS) processes (Change Control, Deviation, CAPA, OOS, etc.).</li><li>Escalate and manage supplier quality issues to closure, including root cause analysis and corrective actions.</li><li>Provide trend reporting and risk metrics to senior leadership.</li></ul>
Continuous Improvement<ul><li>Proactively identify opportunities to strengthen supplier quality processes and enhance regulatory robustness.</li><li>Lead initiatives to modernize and streamline supplier management tools, metrics, and reporting.</li></ul>
Cross-Functional Collaboration<ul><li>Partner with Purchasing, Operations, and Corporate QA to ensure supplier reliability, compliance, and business continuity.</li><li>Partner with IT and other application specialists to ensure inventory systems (LIMS, SAP, etc.) are used effectively across all business lines.</li><li>Engage with senior leadership to communicate supplier risk, strategy, and performance.</li></ul> 
Qualifications<ul><li>Bachelor of Science degree in Chemistry, Microbiology, Engineering, Quality/Regulatory Sciences, or related field.</li><li>5+ years of experience in Quality Assurance/Regulatory Affairs in a GMP-regulated pharmaceutical/biologics environment (including at least 3+ years in supplier quality).</li><li>2+ years of supervisory/management experience, with demonstrated success leading teams.</li><li>Strong working knowledge of 21 CFR Part 211 and/or 21 CFR Part 212, including practical application in supplier qualification. Working knowledge of EudraLex Volume 4 and ROW regulations preferred.</li><li>Demonstrated ability to lead audits, regulatory inspections, and cross-functional initiatives.</li></ul>
 Excellent leadership and communication skills. Ability to manage multiple priorities in a fast-paced environment. Travel up to 25% (domestic and limited international)</div></div>

Sr. Supplier Manager

<div><div>Start your pharmacy career in a unique, hands-on role that goes beyond the typical pharmacy setting.
At SOFIE, we specialize in preparing radiopharmaceuticals &mdash; life-saving imaging drugs used in hospitals and clinics across the country. As a Pharmacy Technician, you&rsquo;ll work side-by-side with licensed Nuclear Pharmacists in a clean, highly controlled environment to help prepare and distribute these important medications. You&rsquo;ll gain valuable experience in sterile compounding, quality control, and pharmacy operations &mdash; all while making a real difference in patient care.
If you're detail-oriented, safety-conscious, and ready to grow in a fast-paced, science-driven workplace, we want to hear from you. 
Overview
The Pharmacy Technician will perform laboratory and pharmacy related duties under the direct supervision of an authorized Nuclear Pharmacist. This job involves working in a clean room as well as occupational exposure to radiation.
Essential Duties and Responsibilities<ul><li>
Perform the duties associated with compounding, dispensing, and distribution of FDG and NaF, including data entry with Pinestar for end-of-day reports and daily dose management reports.
</li><li>Ensure compliance with USP &lt;797&gt;, &lt;823&gt;, proposed &lt;825&gt; regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws.</li><li>
Complete cGMP documents as required within SOFIE&rsquo;s Quality Management System.
</li><li>Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations.
</li><li>Maintain a clean and safe working environment.</li><li>
Perform radiation safety duties according to SOFIE&rsquo;s Corporate Radiation Compliance Program and site licensing requirements.</li><li>
Provide quality customer service associated with radiopharmaceuticals to physicians, healthcare workers, customers, etc.:</li><li>
Take orders from customers as applicable by state regulations</li><li>
Follow-up with customer inquiries
</li><li>Document pharmacy/customer complaints and immediately notify pharmacist</li><li>
Perform inventory management:</li><li>
Maintain production/QC/cleaning supply levels as appropriate</li><li>
Perform inventory reporting</li><li>
Perform material acceptance according to SOPs</li><li>
Clean classified and non-classified areas according to SOPs.</li><li>
Perform environmental monitoring of classified areas according to SOPs.</li><li>
Complete cGMP documents as required and assist site and corporate Quality Assurance as required.</li><li>
Attend internal meetings as required.</li><li>
Other assigned duties as required.
</li></ul>Qualifications<ul><li>
High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred. (As applicable to state laws).</li><li>
Pharmacy Technician Licensure or Certification as required by state law.</li><li>
Experience with sterile compounding and aseptic operations preferred.
</li><li>Efficient in the use of MS Office Suite required.</li><li>
Ability to work various shifts and weekends required.</li><li>
Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
</li><li>Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.
</li><li>Ability to lift ~50 lbs. required.
</li><li>Up to 5% travel required.</li></ul></div></div>

Pharmacy Technician

Join Sofie and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Sofie

About Company

Sr. Supplier Manager

Pharmacy Technician