Align Technology
Sr. Director of Packaging and Labeling
Align Technology, San Jose, California, United States, 95199
Overview
Sr. Director of Packaging and Labeling at Align Technology Department:
Marketing Location:
US-California-San Jose Compensation:
$230,500 - $316,900 / year The Senior Director of Packaging and Labeling at Align Technology is responsible for advancing compliance oversight for packaging and labeling end-to-end processes and tooling, compliance oversight, and product launches globally. This role involves collaboration with 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. 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. This role will be located in San Jose, CA and has direct reports.
Role expectations
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. Provide 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. Recruit, direct, motivate and develop teams, maximizing contribution and professional growth. 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 and ensure proactive localization readiness (e.g., MDR, FDA, PMDA, Health Canada, LATAM ANVISA, CFDA). Design and implement functional/department goals; contribute to the development of operational strategy and annual business plans. Travel approximately 30%.
What we're looking for
Bachelor's degree in a scientific or allied health field (or equivalent). Typically requires 15 years of work experience and 7 years of management experience, or equivalent combination of education and experience. 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 packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, qualification, and related equipment. Experience supporting packaging for medical device products from research through registration and launch. Knowledge of packaging and labeling requirements globally. Experience applying risk-based quality principles in a medical device and/or pharmaceutical environment. Demonstrated strategic planning and execution skills; proven leadership in a multi-level organization. Experience with program and enterprise risk management; familiarity with Root Cause Analysis and Operational Excellence methodologies (LEAN, DMAIC, Six Sigma).
Benefits and comply
Pay Transparency and general description of benefits are provided in the posting. Align offers benefits including medical, dental, vision, disability, life insurance, 401(k) with company match, Employee Stock Purchase Program, paid vacation and holidays, parental leave, and other programs as described in the original posting. This section also contains the employer’s Equal Opportunity Statement and privacy information as described in the original posting.
Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
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Sr. Director of Packaging and Labeling at Align Technology Department:
Marketing Location:
US-California-San Jose Compensation:
$230,500 - $316,900 / year The Senior Director of Packaging and Labeling at Align Technology is responsible for advancing compliance oversight for packaging and labeling end-to-end processes and tooling, compliance oversight, and product launches globally. This role involves collaboration with 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. 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. This role will be located in San Jose, CA and has direct reports.
Role expectations
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. Provide 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. Recruit, direct, motivate and develop teams, maximizing contribution and professional growth. 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 and ensure proactive localization readiness (e.g., MDR, FDA, PMDA, Health Canada, LATAM ANVISA, CFDA). Design and implement functional/department goals; contribute to the development of operational strategy and annual business plans. Travel approximately 30%.
What we're looking for
Bachelor's degree in a scientific or allied health field (or equivalent). Typically requires 15 years of work experience and 7 years of management experience, or equivalent combination of education and experience. 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 packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, qualification, and related equipment. Experience supporting packaging for medical device products from research through registration and launch. Knowledge of packaging and labeling requirements globally. Experience applying risk-based quality principles in a medical device and/or pharmaceutical environment. Demonstrated strategic planning and execution skills; proven leadership in a multi-level organization. Experience with program and enterprise risk management; familiarity with Root Cause Analysis and Operational Excellence methodologies (LEAN, DMAIC, Six Sigma).
Benefits and comply
Pay Transparency and general description of benefits are provided in the posting. Align offers benefits including medical, dental, vision, disability, life insurance, 401(k) with company match, Employee Stock Purchase Program, paid vacation and holidays, parental leave, and other programs as described in the original posting. This section also contains the employer’s Equal Opportunity Statement and privacy information as described in the original posting.
Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
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