Regional Manager, Quality Assurance

Job Description | Regional Manager, Quality Assurance

Title | Regional Manager, Quality Assurance

Location | Variable, within 50 miles of the designated SOFIE facilities (Under Corporate (CO1))

Department | Quality & Compliance

Reports To | Director, Quality Assurance

Compensation | $95,000 - $100,000/yr

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 of 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 all 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 network and

site-specific procedures relative to their job functions.

• Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA for sites within a

given region.

• 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

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 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 noncompliance 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

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 obsoleted 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 / Requirements

• 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.

• Availability to travel up to 40% domestically.