Quality Manager, Partners - SOFIE
Romeoville, IL 60446
About the Job
Job Description | Quality Manager, Partners
Title | Quality Manager, Partners
Location | Open
Department | Quality/Regulatory/EH&S
Reports To | Director, Quality Management, Partners & Training
Overview
SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities.
Essential Duties and Responsibilities
▪ Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
▪ Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors.
▪ Assist in the roll-out of new products at SOFIE network sites.
▪ Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continuing to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and companywide.
▪ Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).
▪ Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training, etc.
▪ Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary. 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 and review cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
▪ Assist with the ongoing training program and present training presentations on applicable job-related procedures and topics.
▪ Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues.
▪ Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.
▪ Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily during each audit. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines.
▪ Review partner customer/patient complaints to determine the possible root causes. Work with the partners and customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.
▪ 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 the key area: Radiopharmaceutical Contract Manufacturing (RCM). \
▪ 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, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience.
▪ 2+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred.
▪ 1+ years’ supervisory experience within a Quality Assurance or Quality Control function preferred.
▪ Experience with FDA regulatory submissions (establishment registration, safety reports, annual reports, amendments, etc.) preferred.
▪ 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.
▪ Ability to project manage and have excellent organization and prioritization skills.
▪ Travel: up to 50% domestically.
Title | Quality Manager, Partners
Location | Open
Department | Quality/Regulatory/EH&S
Reports To | Director, Quality Management, Partners & Training
Overview
SOFIE is committed to all aspects of Quality and Compliance in the production of the Radiopharmaceutical products they manufacture. This role supports the Director, Quality Assurance, Partners & Training, and provides Quality leadership to the Radiopharmaceutical Contract Manufacturing (RCM) division throughout the SOFIE network. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US. The successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This person will play an active and integral part of the Quality team supporting compliance, improvement, and implementation with all RCM products at all SOFIE facilities.
Essential Duties and Responsibilities
▪ Provide quality assurance support to the Radiopharmaceutical Contract Manufacturing (RCM) group within the SOFIE Network. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
▪ Be a quality liaison, develop solid relationships, and establish open communication with SOFIE partners and sponsors.
▪ Assist in the roll-out of new products at SOFIE network sites.
▪ Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Part 211 and 212 requirements, and continuing to establish an effective and efficient quality management system at one SOFIE facility, at minimum, and companywide.
▪ Provide Quality Leadership to develop, maintain, and continually improve the Quality Management System (QMS).
▪ Assist Director, RCM, Directors, Quality Management, Directors, QA and Regional Managers, QA with quality initiatives, decisions, and training, etc.
▪ Review, edit, and approve Change Control, Deviation, OOS investigation, and CAPA when necessary. 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 and review cGMP documents, including various procedures, protocols, specifications, reports, records, and changes to these documents.
▪ Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures relative to their job functions.
▪ Assist with the ongoing training program and present training presentations on applicable job-related procedures and topics.
▪ Identify non-compliance problems and propose solutions as appropriate. Effectively interact with other functional personnel at the site and corporate level and resolve quality related issues.
▪ Initiate action plans to prevent cGMP non-compliance and product quality problems proactively. Ensure continuous and sustained improvements.
▪ Liaise with corporate QA for audits, customer audits, partner audits, and regulatory agency audits. Perform readiness assessment and take corrective actions as needed prior to the audits. Summarize and report auditing progresses daily during each audit. Prepare complete responses to the audit outcomes on time. Ensure corrective actions being implemented according to the committed timelines.
▪ Review partner customer/patient complaints to determine the possible root causes. Work with the partners and customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.
▪ 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 the key area: Radiopharmaceutical Contract Manufacturing (RCM). \
▪ 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, Quality and Regulatory Affairs, Regulatory Science, etc. preferred but will entertain applicants with relevant education and work experience.
▪ 2+ years of work experience in Quality Assurance or Regulatory Affairs in a cGMP pharmaceutical and/or biological manufacturing regulated environment preferred.
▪ 1+ years’ supervisory experience within a Quality Assurance or Quality Control function preferred.
▪ Experience with FDA regulatory submissions (establishment registration, safety reports, annual reports, amendments, etc.) preferred.
▪ 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.
▪ Ability to project manage and have excellent organization and prioritization skills.
▪ Travel: up to 50% domestically.
Source : SOFIE