Regional Manager, QA

Title | Regional Manager, Quality Assurance
Location | Remote based out of any SOFIE Locations
Department | Quality/Regulatory/EH&S
Reports To | Director, Quality Assurance

Overview
SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This is a high-profile role providing Quality leadership to the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will play an active and integral part in the Quality team supporting compliance and improvement for a given region of SOFIE facilities (approximately 4-5 sites).

Essential Duties and Responsibilities

• Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, by implementing an effective and efficient quality management system and maintaining a state of cGMP control for sites within a given region.
• Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).
• Oversee quality-related activities of routine radiopharmaceutical manufacture and directly supervise site-level Quality Assurance Specialists within a given region.
• Release clinical and commercial finished product batches, final drug product labels, reagents, manufacturing batch records, associated EM data, QC analytical testing results, and Certification of Analysis for conformance to SOPs, specifications, regulations, and other applicable acceptance criteria to ensure compliance and product quality as required.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE site-specific specific procedures relative to their job functions.
• Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites within a given region.
• Close follow-up and follow-up on these activities for timely closure. Ensure that scientifically sound investigations are conducted, and root causes are identified. Initiate and implement CAPA plans. Evaluate the effectiveness of the CAPA plans through reporting and trending.
• Author, review, and approve cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
• Monitor and oversee the ongoing training program to qualify the site QASs to follow SOPs to always perform their job functions. Ensure the training covers any newly released procedures, revised procedures, and cGMP updates. Track individuals’ training requirements and ensure all training is on time and documented.
• Ensure aseptic operations are in compliance with internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations for sites within a given region. Assure completeness, accuracy, traceability, and compliance of the site’s utility and facility monitoring methods and records.
• Monitor the metrology program for sites within a given region. Ensure that all equipment is appropriately maintained, calibrated/recalibrated, or validated/revalidated in a timely manner. Ensure a comprehensive tracking system is implemented and followed.
• Ensure that raw materials, components, containers, closures, packaging, and labeling are inspected, qualified, and meet acceptance criteria before use for sites within a given region. Ensure all materials are properly organized, controlled, and secured.
• Provide QA oversight of manufacturing, QC, and other cGMP activities for sites within a given region. Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site level and resolve quality-related issues.
• Regularly conduct internal self-audit for quality management system effectiveness for sites within a given region. Document the findings in a self-audit report. Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.
• Liaise with corporate QA audits, customer audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily. Prepare complete responses to the audit outcomes on time. Ensure corrective actions are being implemented according to the committed timelines.
• Review customer/patient complaints to determine the possible root causes. Work with the customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.
• Ensure that the site cGMP documents are properly organized, controlled, and securely archived. Ensure all SOPs are up to date and any obsolete documents are removed.
• Maintain knowledge of current regulations and quality policies. Attend quality-related meetings and conference calls. Interface with corporate QA on quality-related issues. Provide quality status updates as required by corporate QA.
• Be a Subject Matter Expert resource for the entire network for a key area: Pharmacy Regulation, Vendor/Material Management, or Change/CAPA management.
• Author or review certain sections of regulatory submissions, including responses to regulatory inquiries as needed.
• Perform other tasks as required.

Qualifications

• Bachelor of Science Degree (B.Sc.) in an appropriate scientific subject, e.g. Chemistry, Microbiology, etc. required.
• 5 years of work experience in Quality Assurance in a cGMP pharmaceutical and/or biological manufacturing regulated environment.
• 2 years’ supervisory experience within a Quality Assurance or Quality Control function.
• Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred.
• Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required.
• Experience leading internal audits preferred.
• Knowledge of current FDA enforcement issues preferred.
• Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required.
• Ability to effectively communicate (written and verbal) with site personnel, corporate QA, customers, and regulatory agencies required.
• Ability to prepare and present written and verbal reports to upper management required.
• Travel: up to 40% domestically.

About the Company:
SOFIE

SOFIE is motivated by Innovation. Passion. Collective genius. Hard work. We believe in nurturing great ideas and great people. From our Board to our Team, we’re dedicated to bringing a new vision of theranostics and innovative technologies to healthcare.

With our acquisition of Zevacor Pharma, Inc in 2017, we have become SOFIE, a combined company of radiopharmacies, contract manufacturing services, radiosynthesizers, and pre-clinical imaging systems. We are especially excited about the possibilities before us in 2018, as we’ll be offering new products and an expanded network to support our belief in life-changing Theranostics, and continue to lead the way in quality, service, and innovation. Together, we’re on a mission to improve patient lives, from start to clinic. If you want to join us in our mission, visit our careers page and help us change the world

We offer a competitive salary, a comprehensive benefits package, and advancement opportunity. SOFIE is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law.

Company Size:
100 to 499 employees

Industry:
Biotechnology/Pharmaceuticals

Founded:
2017

Website:
https://sofie.com/

Salary : $95,000 - $110,000