CPT Clinical Operations Director Jobs
Clinical Operations Director roles sit at the intersection of regulatory compliance, cross-functional leadership, and clinical trial oversight, all of which map directly to graduate-level programs in clinical research, public health, and healthcare administration. CPT authorization requires your DSO to verify the role is integral to your curriculum, so document how the position aligns with your degree requirements before approaching employers.
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Get Access To All JobsINTRODUCTION
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
THE ROLE
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Associate Operator. Under close supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals.
This position will be onsite in Carlsbad, CA.
THE RESPONSIBILITIES
- Operates equipment used to manufacture products.
- Checks and inspects products against departmental procedures.
- Responsible for recognizing product or equipment problems that arise during the manufacturing process.
- May be required to assist with the set-up and clean-up of manufacturing equipment.
- Responsible for Lean Initiatives.
- Carries out duties in compliance with established business policies.
- Performs other duties and projects assigned.
THE INDIVIDUAL
Required:
- 0 - 2 years of related experience required.
- Basic knowledge of regulations (FDA, ISO, OSHA, etc.).
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- This position is not currently eligible for visa sponsorship.
Preferred:
- High school diploma or equivalent.
- Experience in medical device manufacturing.
- MS Office and manufacturing systems.
THE KEY WORKING RELATIONSHIPS
Internal Partners:
Mechanics, Engineers and Management
External Partners:
Vendors and Contractors
THE WORK ENVIRONMENT
The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Works on assignments that are routine in nature.
THE PHYSICAL DEMANDS
Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.
SALARY TRANSPARENCY
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $41,365.59 - $52,741.13 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
EQUAL OPPORTUNITY
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
INTRODUCTION
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
THE ROLE
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as our next Associate Operator. Under close supervision, this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals.
This position will be onsite in Carlsbad, CA.
THE RESPONSIBILITIES
- Operates equipment used to manufacture products.
- Checks and inspects products against departmental procedures.
- Responsible for recognizing product or equipment problems that arise during the manufacturing process.
- May be required to assist with the set-up and clean-up of manufacturing equipment.
- Responsible for Lean Initiatives.
- Carries out duties in compliance with established business policies.
- Performs other duties and projects assigned.
THE INDIVIDUAL
Required:
- 0 - 2 years of related experience required.
- Basic knowledge of regulations (FDA, ISO, OSHA, etc.).
- Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
- Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- This position is not currently eligible for visa sponsorship.
Preferred:
- High school diploma or equivalent.
- Experience in medical device manufacturing.
- MS Office and manufacturing systems.
THE KEY WORKING RELATIONSHIPS
Internal Partners:
Mechanics, Engineers and Management
External Partners:
Vendors and Contractors
THE WORK ENVIRONMENT
The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines. Works on assignments that are routine in nature.
THE PHYSICAL DEMANDS
Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.
SALARY TRANSPARENCY
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $41,365.59 - $52,741.13 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
EQUAL OPPORTUNITY
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
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Get Access To All JobsClinical Operations Director CPT: Frequently Asked Questions
Does a Clinical Operations Director role qualify for CPT authorization?
Yes, if your degree program includes clinical research management, healthcare administration, or a related field and the role's responsibilities directly satisfy your curriculum's learning outcomes. Your DSO will evaluate whether the position is integral to your program, not just relevant to your career. A strong CPT application includes the job description, the specific course or practicum the role fulfills, and a written statement from your academic advisor confirming the alignment.
Can I do CPT in a director-level role, or does it have to be an entry-level position?
CPT has no seniority restriction. What matters is that the work is authorized as part of your curriculum and that your DSO approves it. Director-level clinical operations roles are increasingly common for graduate students in public health, clinical research, and healthcare management programs, particularly during dissertation or capstone phases where the role provides direct experiential credit.
How does full-time CPT affect my OPT eligibility after graduation?
Using 12 or more months of full-time CPT eliminates your OPT eligibility entirely. Part-time CPT, regardless of total duration, does not affect OPT. If you're planning to work full-time in a Clinical Operations Director role on CPT, track your authorized days carefully. USCIS uses your I-20 CPT endorsements to calculate the total, so review every authorization your DSO has issued before committing to a full-time engagement.
What should I look for in a Clinical Operations Director CPT role to support a future H-1B petition?
Look for employers who have filed Labor Condition Applications for operations leadership roles in the past, have documented specialty occupation justifications for the position, and are enrolled in E-Verify. The role should require at minimum a bachelor's degree in a directly related field. You can verify an employer's LCA filing history through the OFLC Wage Search, and you can browse CPT-accessible positions from sponsoring employers on Migrate Mate.
Do Clinical Operations Director CPT roles typically require security clearance or regulatory credentials?
Many clinical operations roles in pharmaceutical, biotech, and contract research organizations require familiarity with FDA regulations, ICH-GCP guidelines, and trial management systems rather than formal security clearances. Some government-adjacent or NIH-funded roles may involve additional background checks. Review the job description carefully during CPT authorization, if the role requires clearance, confirm your eligibility before your DSO submits the authorization request, as clearance delays can affect your CPT start date.
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