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Sr. Director of Packaging and Labeling

San Jose, United States

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.
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.
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.

About Align Technology

Your growth and well-being:

At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:

Health and well-being programs to keep you thriving in both body and mind.
Employee-exclusive discounts on Invisalign products.
Learning opportunities through online learning resources and support for your individual development plans.
Inclusive, global workplace that fosters collaboration, recognition and belonging.

Country and/or role specific details will be shared with you by your recruiter during the interview process.

Discover Align:

We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.

Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.

We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.

Eager to learn how we embrace our global differences and nurture employee well-being?
Explore Align's culture here!

Want to discover more about exocad and Cubicure? Click on their names for additional information.

Applicant Privacy Policy:

Review our Applicant Privacy Policy for additional information.

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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