OPT Project Leader Jobs
Project Leader jobs on OPT require employers willing to sponsor H-1B visa or support your status transition before your work authorization expires. Most roles in this title fall under specialty occupation criteria, making them well-suited for STEM OPT extensions if your degree is in engineering, computer science, or a related technical field.
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Collaborates with the Sr. Director, Quality Assurance to provide project management for compliance topics and continuous improvement program management to support the company's short- and long-term goals for maintaining quality systems, compliance, and efficiency. This includes direct oversight for the evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and release of finished product. This includes oversight for the final review of investigation to ensure product quality, and appropriate implementation of corrective actions in a timely manner to prevent recurrence.
Salary: $90,000 to $110,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
- Serve as a change agent performing project management duties (PMO).
- Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team.
- Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities.
- Provide progress reports, assist in removing barriers, and escalate issues when additional support is needed.
- Manage projects that primarily focus on compliance or continuous improvement / simplification category.
- Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT).
- Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management.
- Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements.
- Consolidate quality metrics and reporting in collaboration with respective QA reporting heads.
- Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
- Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors.
- Prepares and presents progress reports for senior management.
- Identify and resolve emerging issues that may impact project or corporate goals.
- Recognize potential threats to project success and elevate issues to senior management.
- Develop and implement contingency plans.
- All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.
Requirements
- Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
- Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Job Summary
Collaborates with the Sr. Director, Quality Assurance to provide project management for compliance topics and continuous improvement program management to support the company's short- and long-term goals for maintaining quality systems, compliance, and efficiency. This includes direct oversight for the evaluation, implementation, execution, and follow-up on quality systems and metrics in support of GMP compliance and release of finished product. This includes oversight for the final review of investigation to ensure product quality, and appropriate implementation of corrective actions in a timely manner to prevent recurrence.
Salary: $90,000 to $110,000
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.
Responsibilities
- Serve as a change agent performing project management duties (PMO).
- Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team.
- Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities.
- Provide progress reports, assist in removing barriers, and escalate issues when additional support is needed.
- Manage projects that primarily focus on compliance or continuous improvement / simplification category.
- Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT).
- Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management.
- Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements.
- Consolidate quality metrics and reporting in collaboration with respective QA reporting heads.
- Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
- Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors.
- Prepares and presents progress reports for senior management.
- Identify and resolve emerging issues that may impact project or corporate goals.
- Recognize potential threats to project success and elevate issues to senior management.
- Develop and implement contingency plans.
- All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the health, safety, environment, energy, and quality management systems, as per their roles and responsibilities.
Requirements
- Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry.
- Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
See all OPT Project Leader Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship in Project Leader
Target employers with an H-1B sponsorship track record
Search OFLC disclosure data to confirm an employer has filed H-1B visa petitions for Project Leader or similar titles before. Past sponsorship behavior is the strongest signal that a company will support your visa transition after OPT ends.
Clarify your STEM OPT eligibility early in interviews
If your degree is in engineering, computer science, or a STEM-designated field, you may qualify for a 24-month STEM OPT extension. Communicating this upfront gives employers a longer runway and reduces perceived sponsorship urgency during hiring.
Frame your cross-functional coordination as a business asset
Project Leaders who can manage stakeholders across engineering, finance, and operations are harder to replace. Emphasizing this breadth during interviews positions you as a retention priority, which directly strengthens the case for sponsorship investment.
Understand your OPT timeline before accepting an offer
Know exactly when your OPT authorization expires and when the H-1B filing window opens. Starting a Project Leader role with only a few months of OPT remaining compresses the timeline for both you and your employer significantly.
Prioritize mid-size and large employers with structured HR processes
Companies with dedicated HR or legal teams are more likely to have established visa sponsorship workflows. Project Leader roles at organizations with 500-plus employees tend to come with clearer sponsorship pathways than early-stage startups.
Obtain a PMP or industry certification before applying
A Project Management Professional certification strengthens your specialty occupation argument by demonstrating field-specific expertise. It also differentiates you from other OPT candidates and signals long-term commitment to employers evaluating sponsorship cost versus return.
Project Leader OPT: Frequently Asked Questions
Do Project Leader jobs qualify for STEM OPT extension?
It depends on your degree, not the job title itself. If your bachelor's, master's, or doctoral degree is in a STEM-designated field and the Project Leader role involves applying that technical knowledge, you likely qualify for the 24-month STEM OPT extension. Your DSO and employer must both sign the I-983 training plan to activate the extension.
Do Project Leader roles qualify as specialty occupations for H-1B purposes?
Many do, but it requires documentation. USCIS evaluates whether the specific role requires a bachelor's degree or higher in a directly related field. Project Leader positions in software, engineering, or healthcare tend to qualify more readily than general operational management roles. Your employer's immigration attorney will assess the job description against USCIS specialty occupation criteria before filing.
How do I find Project Leader jobs that sponsor OPT and H-1B visas?
Migrate Mate lists Project Leader roles from employers with verified visa sponsorship history, so you're not guessing which companies are open to OPT candidates. You can browse roles filtered to your situation without sorting through postings that don't support work authorization.
Can I start a Project Leader job before my OPT EAD card arrives?
No. You cannot begin working until your EAD card is physically in hand and your OPT start date has passed. If an employer wants you to start before your card arrives, the offer start date needs to be pushed back. Starting work without a valid EAD violates your F-1 status and can jeopardize future visa applications.
What happens to my Project Leader job if my H-1B lottery application isn't selected?
If you're not selected in the H-1B lottery and your OPT expires, you lose work authorization and must stop working. Some employers respond by exploring cap-exempt H-1B options through qualifying nonprofit or university affiliates, pursuing O-1 visa classification for candidates with strong project leadership credentials, or supporting a departure and consular H-1B filing the following fiscal year.