Quality Assurance Manager at SOFIE

Overview

SOFIE is committed to all aspects of Quality and Compliance in the manufacture of Radiopharmaceutical products. This role provides Quality leadership to defined SOFIE facilities (and the network). SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will play an active and integral part of the Quality team supporting compliance and improvement for an assigned SOFIE facility (or facilities). The applicant will be responsible for the Quality Management System (QMS) at the given SOFIE facility (or facilities) and manage the site Quality Assurance Specialist(s). The candidate must be strong at technical and quality writing, root cause analysis, identifying trends, and establishing and implementing robust corrective and preventive actions. The candidate must also be able to learn technical, scientific, and quality processes to aid in the oversight of SOFIE and Partner drug products.

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 all quality-related activities of routine radiopharmaceutical manufacture and directly supervise site-level Quality Assurance Specialists within a given facility or facilities.

▪     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.

▪     Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites. Closely track 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 perform their job functions at all times. Ensure the training covers any newly released procedures, revised procedures, and cGMP updates. Track individuals’ training requirements and ensure all trainings are 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 site. Assure completeness, accuracy, traceability, and compliance of the site’s utility and facility monitoring methods and records.

▪     Monitor the metrology program for given site(s). 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

▪     Other responsibilities as required.

▪     The description provided above is not intended to be an exhaustive list of all job duties, responsibilities, and requirements.  Duties, responsibilities, and requirements may change over time and according to business need.

Qualifications

▪     Bachelor’s Degree required (science, technical, or quality degree preferred)

▪     4+ 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.

▪     Experience leading internal audits preferred.

▪     Knowledge of USP, FDA, and cGMP regulations 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.

▪     Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.

▪     Knowledge of how and ability to write, review, and revise exception reports and SOPs required.

▪     Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.

▪     Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.

▪     Ability to write reports, business correspondences, and procedure manuals required.

▪     Ability to effectively present information, deliver training, and respond to questions from groups of colleagues, managers, partners, and customers required.

▪     Ability to define problems, collect data, establish facts and draw valid conclusions required.

▪     Ability to solve problems and handle issues required.

▪     Proficient in MS Office applications required.

▪     Travel: up to 40% domestically.