What are the responsibilities and job description for the Operations Manager- Label and Packaging position at Fagron?
Who We Are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
About The Job
The Label and Packaging Manager is responsible for overseeing all labeling and packaging activities for sterile drug products in compliance with FDA 503B regulations, cGMP standards, internal quality systems and production schedules. This includes managing manual and automated labeling processes, training personnel, maintaining documentation, continuous improvement intiatives and ensuring product integrity prior to release.
Key Responsibilities
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge?
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.
About The Job
The Label and Packaging Manager is responsible for overseeing all labeling and packaging activities for sterile drug products in compliance with FDA 503B regulations, cGMP standards, internal quality systems and production schedules. This includes managing manual and automated labeling processes, training personnel, maintaining documentation, continuous improvement intiatives and ensuring product integrity prior to release.
Key Responsibilities
- Lead, develop, and manage the label and packaging teams, ensuring adherence to SOPs and cGMP standards.
- Oversee the accurate label and packaging of sterile injectable products.
- Collaborate with Quality and Production to investigate label and packaging-related deviations and non-conformances.
- Ensure compliance with FDA 503B requirements and industry best practices for sterile product inspection.
- Support investigations related to labeling discrepancies, mix-ups, deviations, and packaging events.
- Manage and trend defect data to identify recurring issues and implement corrective actions.
- Participate in internal and regulatory audits as the subject matter expert (SME) for labeling and packaging.
- Support the qualification, validation, and maintenance of automated labeling systems.
- Maintain compliance with GDP (Good Documentation Practices) requirements.
- Review and trend packaging errors, deviations, and documentation issues.
- Implement corrective and preventive actions (CAPAs) related to packaging operations.
- Bachelor’s degree in life sciences, engineering business or regulatory preferred
- 3 years of experience working in a regulated environment
- 2 years of leadership or supervisory experience preferred
- Excellent attention to detail and documentation skills.
- Strong analytical, organizational, and communication abilities.
- Familiarity with quality management systems, deviation/CAPA systems, and audit processes.
- Ability to work cross-functionally in a fast-paced regulated environment.
- Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
- Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
- Strong attention to detail and focus on quality, accuracy, and accountability.
- Promote a culture of quality, compliance, teamwork, and continuous improvement.
- Support employee engagement and retention initiatives.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
Ready for the challenge?
Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.