Green Card Operations Director Jobs
Operations Director roles qualify for EB-2 and EB-3 green card sponsorship when the position requires a bachelor's degree or higher in business, operations management, or a related field. Employers file a PERM labor certification with the DOL before sponsoring you, documenting that no qualified U.S. worker is available for the role.
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Get Access To All JobsINTRODUCTION
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
ROLE AND RESPONSIBILITIES
This position will provide quality oversight of Denali’s external manufacturing network (CMO). This position will also support batch release, investigations, change management and documentation for given outsourced project activities.
Key Accountabilities/Core Job Responsibilities:
- Oversee both clinical and commercial GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and specifications of Denali products.
- Oversee end to end product quality management across the entire supply chain and distribution networks from GLP tox batches to Commercial release.
- Accountable for batch release disposition across the clinical and commercial product portfolio.
- Support CMC development including review and approval of specifications, stability studies, method validation, QC test methods, process validation and material distribution activities.
- Support CMC commercial operations including establishing infrastructure, SOPs and execution for Product Launch activities.
- Write and approve SOPs and Policies related to compliance and quality.
- Provide Quality expertise for regulatory inspections, inspection-readiness activities, and responses to regulatory observations.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
BASIC QUALIFICATIONS
- Typically requires a BS in a scientific discipline (MS preferred) with 12+ years of GMP experience in the Pharmaceutical industry, including 10+ years of coaching, mentoring and direct people management experience.
- A professional certification in quality, compliance and/or regulatory is a plus.
- Experience with CMOs, and CMC development. Large molecule and commercialization experience is a plus.
- Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
- Experience with electronic QMS/LMS platforms such as Veeva, Master Control, ComplianceWire or equivalent desirable.
- Able to travel domestically and internationally.
COMPENSATION
- Salary Range: $229,000.00 to $297,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
INTRODUCTION
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
ROLE AND RESPONSIBILITIES
This position will provide quality oversight of Denali’s external manufacturing network (CMO). This position will also support batch release, investigations, change management and documentation for given outsourced project activities.
Key Accountabilities/Core Job Responsibilities:
- Oversee both clinical and commercial GMP and GLP quality operations at CMOs, including quality documentation reviews and approvals, from Manufacturing and Quality Control, such as batch records, change controls and specifications of Denali products.
- Oversee end to end product quality management across the entire supply chain and distribution networks from GLP tox batches to Commercial release.
- Accountable for batch release disposition across the clinical and commercial product portfolio.
- Support CMC development including review and approval of specifications, stability studies, method validation, QC test methods, process validation and material distribution activities.
- Support CMC commercial operations including establishing infrastructure, SOPs and execution for Product Launch activities.
- Write and approve SOPs and Policies related to compliance and quality.
- Provide Quality expertise for regulatory inspections, inspection-readiness activities, and responses to regulatory observations.
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
BASIC QUALIFICATIONS
- Typically requires a BS in a scientific discipline (MS preferred) with 12+ years of GMP experience in the Pharmaceutical industry, including 10+ years of coaching, mentoring and direct people management experience.
- A professional certification in quality, compliance and/or regulatory is a plus.
- Experience with CMOs, and CMC development. Large molecule and commercialization experience is a plus.
- Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines.
- Experience with electronic QMS/LMS platforms such as Veeva, Master Control, ComplianceWire or equivalent desirable.
- Able to travel domestically and internationally.
COMPENSATION
- Salary Range: $229,000.00 to $297,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
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Get Access To All JobsTips for Finding Green Card Sponsorship in Operations Director
Document your degree's equivalency early
PERM requires your foreign degree to meet the job's minimum requirements. Get a credential evaluation from a NACES-approved evaluator before applying, so employers don't delay sponsorship over unanswered questions about your qualifications.
Target employers with prior PERM filings
Use Migrate Mate to filter Operations Director roles by green card sponsorship history. Companies that have filed PERM for this title before understand the process and are far less likely to withdraw sponsorship mid-application.
Verify the prevailing wage before negotiating
DOL's OFLC Wage Search lists the prevailing wage for Operations Director by location and experience level. Your offer must meet or exceed this figure, so check it before salary discussions to avoid a PERM denial on wage grounds.
Ask about EB-2 versus EB-3 filing during the offer stage
If you hold a master's degree or your role genuinely requires one, push for EB-2 filing. EB-2 can mean faster priority date movement for some countries, and employers have discretion over which category they file under.
Understand that PERM advertising timelines affect your start
Employers must complete DOL-mandated recruitment steps before USCIS sees your I-140. That process alone takes three to six months. Build this into your timeline when accepting an offer, especially if you're transitioning from a temporary status.
Use O*NET to align your resume with PERM job duties
PERM applications define the role using SOC-coded job duties. Review the O*NET profile for Operations Director before applying so your resume mirrors the exact duties the employer will cite in their labor certification filing.
Green Card Operations Director: Frequently Asked Questions
Does an Operations Director role qualify for EB-2 or EB-3 green card sponsorship?
Operations Director typically qualifies for both EB-2 and EB-3 depending on how the employer defines the position's minimum requirements. If the role requires a master's degree or a bachelor's plus five or more years of progressive experience, EB-2 is the right category. Roles requiring a bachelor's degree alone generally fall under EB-3. The employer's PERM job description drives which category applies.
How does green card sponsorship differ from H-1B sponsorship for this role?
Green card sponsorship through PERM leads to permanent residency, not a temporary status with renewal deadlines. Unlike H-1B visa, there's no annual lottery for employment-based green cards, and EB-3 has no annual cap at the petition level. The tradeoff is timeline: PERM plus I-140 plus adjustment of status routinely takes two to four years or longer depending on your country of birth.
What does the PERM process require from an Operations Director candidate?
Your employer bears most of the PERM burden, running DOL-mandated recruitment to show no qualified U.S. worker is available. Your role is to ensure your credentials match the minimum requirements in the PERM job order exactly. Any mismatch between your actual qualifications and the certified job description can create problems at the I-485 stage.
Where can I find Operations Director jobs that offer green card sponsorship?
Migrate Mate is built specifically for this search. You can filter Operations Director roles by employers who have a documented history of EB-2 and EB-3 sponsorship, which saves significant time compared to applying broadly and then discovering an employer won't sponsor during the offer stage.
Can I switch employers after my I-140 is approved?
Yes, under AC21 portability rules you can change employers after your I-140 has been approved and your I-485 has been pending for 180 days or more, as long as the new role is in the same or a similar occupational classification. Operations Director to a comparable senior operations role would generally qualify, but you should confirm the SOC code alignment with your new employer before making the move.