Align Technology, Inc.
Sr. Director of Packaging and Labeling
Align Technology, Inc., San Jose, California, United States, 95199
Sr. Director of Packaging and Labeling
Department:
Marketing
Employment Type:
Full Time
Location:
US-California-San Jose
Compensation:
$230,500 - $316,900 / year
Description The Senior Director of Packaging and Labeling at Align Technology 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. 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 have 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.
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.
Travel ~30%.
What we're looking for
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.
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.
Pay Transparency If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.
For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.
Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.
General Description of All Benefits
We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.
Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees:
Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
Back-up Child/Elder Care and access to a caregiving concierge
Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
Breast Milk Delivery and Lactation Support Services
Employee Assistance Program
Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan
Employee benefits. Align offers its employees:
Short-term and long-term disability insurance in accordance with those plans.
Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
Flexible Spending Accounts– Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
11 Company-designated paid holidays throughout the year.
If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.
To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
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Marketing
Employment Type:
Full Time
Location:
US-California-San Jose
Compensation:
$230,500 - $316,900 / year
Description The Senior Director of Packaging and Labeling at Align Technology 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. 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 have 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.
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.
Travel ~30%.
What we're looking for
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.
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.
Pay Transparency If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.
For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.
Our internship hourly rates are a standard pay determined based on the position and your location, year in school, degree, and experience.
General Description of All Benefits
We are pleased to provide a general description of the benefits Align offers to full-time employees in this position.
Family Benefits. Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans. Align also offers to employees:
Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
Back-up Child/Elder Care and access to a caregiving concierge
Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
Breast Milk Delivery and Lactation Support Services
Employee Assistance Program
Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan
Employee benefits. Align offers its employees:
Short-term and long-term disability insurance in accordance with those plans.
Basic Life Insurance and Accidental Death and Dismemberment. Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans.
Flexible Spending Accounts– Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan.
401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible).
Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days. Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
11 Company-designated paid holidays throughout the year.
If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave. All parental leave must be completed within one year of the birth or placement of the child. Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
Non-exempt employees will receive full pay for up to 10 days of jury duty. Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.
To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
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