Green Card Chief Operating Officer Jobs
Chief Operating Officer roles can qualify for EB-2 or EB-3 green card sponsorship through the PERM labor certification process, which requires employers to document recruiting efforts before filing an I-140 petition. COO positions typically meet the advanced-degree standard for EB-2 given their cross-functional leadership scope and organizational complexity.
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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 Chief Operating Officer
Document your executive credentials before applying
PERM requires your employer to certify that no qualified U.S. worker is available for the role. Your resume, org charts, and board-level reporting lines should make the COO-level scope of your prior roles unambiguous before the labor certification filing begins.
Target companies with established PERM filing histories
Not all organizations sponsoring C-suite roles have the HR infrastructure to manage a multi-year green card process. Prioritize publicly traded companies, PE-backed firms, and large nonprofits where dedicated immigration counsel is already in place.
Verify the prevailing wage tier before accepting an offer
PERM wages are set at one of four DOL levels. For COO roles, misclassification at Level II instead of Level III or IV can create compliance problems. Cross-reference the job duties against the OFLC Wage Search before the labor certification is filed.
Search for green card sponsoring COO jobs on Migrate Mate
COO-level PERM cases are less common than mid-level roles, so filtering by sponsorship willingness matters. Migrate Mate surfaces companies actively filing employment-based green card cases, letting you focus outreach on employers already committed to the process.
Clarify the EB-2 versus EB-3 classification early
Whether your COO offer is classified EB-2 or EB-3 affects your priority date and wait time, especially if you were born in India or China. Ask the employer's immigration counsel which category the job description supports before the I-140 is filed.
Understand how job duties shape the PERM job description
USCIS scrutinizes whether COO duties genuinely require an advanced degree. The O*NET occupation profile for operations executives can anchor the educational requirement in the PERM job description and reduce the risk of a request for evidence on the I-140.
Green Card Chief Operating Officer: Frequently Asked Questions
Can a Chief Operating Officer role qualify for EB-2 green card sponsorship?
Yes. COO positions typically qualify for EB-2 because the role requires an advanced degree or its equivalent in business, management, or a related field. The employer must document this requirement in the PERM job description and demonstrate that the position genuinely demands graduate-level education. Roles with broad P&L responsibility and cross-functional leadership scope generally meet this standard without difficulty.
How does the green card process differ from H-1B sponsorship for a COO?
H-1B visa is a temporary nonimmigrant status with a six-year base limit and an annual lottery at the cap-subject level. The EB-2 and EB-3 green card process is permanent and has no lottery. The tradeoff is time: PERM labor certification, I-140 approval, and adjustment of status together take two to four years for most countries, and longer for nationals of India and China due to priority date backlogs.
How long does the PERM labor certification process take for executive roles?
Standard PERM processing at the DOL currently runs six to eighteen months from filing to certification. Executive roles sometimes attract closer audits because the recruiting requirements and job duties are more complex to document. Employers should expect the full green card timeline, from PERM filing through I-485 approval, to span three to five years for most applicants outside of per-country backlog countries.
Where can I find COO roles that specifically offer green card sponsorship?
Migrate Mate filters job listings by verified employment-based sponsorship history, which is particularly useful for COO searches where sponsorship willingness varies widely by company size and industry. Searching by role type and green card sponsorship status together narrows the field to employers already experienced with PERM filings, reducing the time spent in early-stage conversations with companies that are unfamiliar with the process.
What happens to my green card case if I change employers after the I-140 is approved?
An approved I-140 petition can be ported to a new employer under AC21 portability rules if your I-485 has been pending for at least 180 days and the new role is in the same or a similar occupational classification. For COO roles, the new position must be broadly comparable in duties and seniority. USCIS evaluates portability on a case-by-case basis, so the job descriptions of both roles should be reviewed before making a move.