Director of Packaging and Labeling (Medical Devices or Pharma domain)
Maxonic Inc., San Jose, California, United States, 95199
The Senior Director of Packaging and Labeling Quality Operations is responsible for advancing compliance oversight for packaging and labeling end to end process and tooling, compliance oversight, and product launches globally. This role involves collaboration with various stakeholders, including Manufacturing, Supply Chain, Regulatory, Operations, Engineering and Design to ensure quality deliverables and support global product launches.
The Sr. Director will lead the development of quality processes, manage improvements, and foster strong partnerships with internal and external teams to enhance quality operations. This role will oversee localization operations across labeling, software, digital platforms, clinical documentation, and marketing materials, driving efficiency, quality, and consistency.
Responsibilities
This role models leadership behaviors, builds an organization capable of ensuring future success, develops leaders, and drives efficiency and risk reduction into relevant internal and external processes. Establish robust Quality Processes/Process Ownership for packaging and labeling validation and commercial product launches. Develop operational processes to support product launches and manage cross-functional discussions regarding label and packaging requirements. Provides leadership to resolve critical issues impacting manufacturing operations in collaboration with relevant stakeholders. Participate in Product expansion activities and product launch risk assessments to ensure quality-related actions are planned and completed. Provide leadership and partner with Quality management for proactive and strategic planning for Packaging & Labeling operations inclusive of process improvements, governance oversight, and tooling. Partner with stakeholders across enabling functions for alignment of strategies and optimization of compliance improvements. Establish and direct the development of Quality Metrics to support process improvement activities. Oversee the translation and localization of all regulated content (IFUs, UDI labeling, clinical trial documents, packaging, eIFUs, SaMD software UI, and marketing claims). Implement standardized workflows, quality control mechanisms, and KPIs to drive compliance and efficiency. Develop and lead the Packaging & Labeling team to support global governance and compliance. Build relationships with cross functional leadership to influence compliance performance. Recruits, directs, motivates and develops teams, maximizing contribution, professional growth and ability to build and sustain a high-performing workforce. Develop and execute a global localization strategy aligned with corporate objectives, regulatory requirements, and market expansion goals. Serve as the executive owner of the enterprise Translation Management System (TMS), Translation Memory (TM), and global terminology governance. Anticipate global regulatory and linguistic trends (MDR, FDA, PMDA, Health Canada, LATAM ANVISA, CFDA, etc.) and ensure proactive localization readiness. Designs and implements functional/department goals; contributes to the development of operational strategy and develops annual business plans to ensure alignment. Qualifications
Bachelor's degree in a scientific or allied health field (or equivalent degree). Typically requires 15 years of work experience and 7 years of management experience, or equivalent combination of education and experience. Required Skills
Excellent communication skills and a proven track record in promoting a culture of Quality and Excellence. Deep knowledge of translation technology (TMS, CAT tools, MT/AI, terminology management). Proven ability to design and implement quality strategies and operational planning. Broad knowledge of global health regulatory agency requirements and industry trends. Experience in one or multiple packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification. Experience supporting packaging for medical device products from research through registration and launch. Knowledge of packaging and labeling requirements globally. Experience in applying risk-based quality principles in a medical device and/or pharmaceutical environment. Demonstrated strategic planning and execution skills. Proven leadership capabilities within a multi-level organization. Experience with implementation and execution of program and enterprise risk management. Familiarity with Root Cause Analysis and Operational Excellence methodologies such as LEAN, DMAIC, Six Sigma.
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This role models leadership behaviors, builds an organization capable of ensuring future success, develops leaders, and drives efficiency and risk reduction into relevant internal and external processes. Establish robust Quality Processes/Process Ownership for packaging and labeling validation and commercial product launches. Develop operational processes to support product launches and manage cross-functional discussions regarding label and packaging requirements. Provides leadership to resolve critical issues impacting manufacturing operations in collaboration with relevant stakeholders. Participate in Product expansion activities and product launch risk assessments to ensure quality-related actions are planned and completed. Provide leadership and partner with Quality management for proactive and strategic planning for Packaging & Labeling operations inclusive of process improvements, governance oversight, and tooling. Partner with stakeholders across enabling functions for alignment of strategies and optimization of compliance improvements. Establish and direct the development of Quality Metrics to support process improvement activities. Oversee the translation and localization of all regulated content (IFUs, UDI labeling, clinical trial documents, packaging, eIFUs, SaMD software UI, and marketing claims). Implement standardized workflows, quality control mechanisms, and KPIs to drive compliance and efficiency. Develop and lead the Packaging & Labeling team to support global governance and compliance. Build relationships with cross functional leadership to influence compliance performance. Recruits, directs, motivates and develops teams, maximizing contribution, professional growth and ability to build and sustain a high-performing workforce. Develop and execute a global localization strategy aligned with corporate objectives, regulatory requirements, and market expansion goals. Serve as the executive owner of the enterprise Translation Management System (TMS), Translation Memory (TM), and global terminology governance. Anticipate global regulatory and linguistic trends (MDR, FDA, PMDA, Health Canada, LATAM ANVISA, CFDA, etc.) and ensure proactive localization readiness. Designs and implements functional/department goals; contributes to the development of operational strategy and develops annual business plans to ensure alignment. Qualifications
Bachelor's degree in a scientific or allied health field (or equivalent degree). Typically requires 15 years of work experience and 7 years of management experience, or equivalent combination of education and experience. Required Skills
Excellent communication skills and a proven track record in promoting a culture of Quality and Excellence. Deep knowledge of translation technology (TMS, CAT tools, MT/AI, terminology management). Proven ability to design and implement quality strategies and operational planning. Broad knowledge of global health regulatory agency requirements and industry trends. Experience in one or multiple packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification. Experience supporting packaging for medical device products from research through registration and launch. Knowledge of packaging and labeling requirements globally. Experience in applying risk-based quality principles in a medical device and/or pharmaceutical environment. Demonstrated strategic planning and execution skills. Proven leadership capabilities within a multi-level organization. Experience with implementation and execution of program and enterprise risk management. Familiarity with Root Cause Analysis and Operational Excellence methodologies such as LEAN, DMAIC, Six Sigma.
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