Sharp Sterile Manufacturing Visa Sponsorship Jobs USA
Sharp Sterile Manufacturing operates in the specialized world of sterile pharmaceutical and biologic contract manufacturing, where technical expertise is in high demand. The company has an established record of sponsoring work visas, making it a viable target for international candidates in the biotech and pharma space.
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The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site’s development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach.
The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization.
The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks.
The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally.
Duties and Responsibilities
- Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program.
- Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA’s Guidance for Industry, “Data Integrity and Compliance with Drug CGMP: Questions and Answers” (Final, 2018)).
- Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums.
- Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives.
- Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.
- Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles.
- Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management.
- Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers.
- Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans.
- Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities.
- Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness.
- Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions.
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations.
- Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity.
Supervisory Responsibilities
- This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program.
Experience
- Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation.
- Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required.
- Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization.
- Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations.
- Demonstrated history of influencing, motivating and effecting change with cross‐functional teams.
- Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications.
- Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience.
- Ability to influence and engage stakeholders at all levels.
- Excellent project management skills with the ability to manage multiple initiatives simultaneously.
- Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights.
- Experience of working in a sterile pharmaceutical manufacturing environment preferred.
Education
- BS or higher degree in an IT, engineering, scientific discipline or other related field. A master’s degree is a plus.
Knowledge, Skills & Abilities
- Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat.
- High attention to detail.
- Good writing, public speaking and presentation skills.
- Must be able to travel approximately 10% of the time.
Physical Requirements
- Ability to sit for prolonged periods of time.
- Ability to stand for prolonged periods of time as required.
- Able to lift up to 10lbs.
Position Summary
The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site’s development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach.
The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization.
The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks.
The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally.
Duties and Responsibilities
- Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program.
- Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA’s Guidance for Industry, “Data Integrity and Compliance with Drug CGMP: Questions and Answers” (Final, 2018)).
- Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums.
- Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives.
- Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.
- Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles.
- Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management.
- Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers.
- Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans.
- Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities.
- Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness.
- Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions.
Regulatory Responsibilities
- Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations.
- Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity.
Supervisory Responsibilities
- This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program.
Experience
- Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation.
- Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required.
- Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization.
- Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations.
- Demonstrated history of influencing, motivating and effecting change with cross‐functional teams.
- Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications.
- Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience.
- Ability to influence and engage stakeholders at all levels.
- Excellent project management skills with the ability to manage multiple initiatives simultaneously.
- Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights.
- Experience of working in a sterile pharmaceutical manufacturing environment preferred.
Education
- BS or higher degree in an IT, engineering, scientific discipline or other related field. A master’s degree is a plus.
Knowledge, Skills & Abilities
- Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat.
- High attention to detail.
- Good writing, public speaking and presentation skills.
- Must be able to travel approximately 10% of the time.
Physical Requirements
- Ability to sit for prolonged periods of time.
- Ability to stand for prolonged periods of time as required.
- Able to lift up to 10lbs.
Job Roles at Sharp Sterile Manufacturing
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Get Access To All JobsTips for Finding Sharp Sterile Manufacturing Visa Sponsorship Jobs USA
Target roles that align with sterile manufacturing expertise
Sharp Sterile Manufacturing's sponsorship activity centers on technical and scientific roles in pharmaceutical manufacturing. Focus your applications on positions in process engineering, quality assurance, regulatory affairs, and analytical chemistry, where international talent is most in demand.
Understand which visa types Sharp supports
Sharp Sterile Manufacturing sponsors H-1B, F-1 OPT, and F-1 CPT visas, along with TN visas for Canadian and Mexican nationals. Knowing this upfront lets you approach the application process with realistic expectations and target the right pathway for your situation.
Use your OPT or CPT window strategically
If you're on F-1 status, Sharp's support for OPT and CPT makes it a practical entry point into U.S. pharma manufacturing. Landing a role during your OPT period positions you well for an H-1B sponsorship conversation before your work authorization expires.
Highlight GMP and regulatory compliance experience
In sterile contract manufacturing, Good Manufacturing Practice credentials carry significant weight. Candidates who demonstrate hands-on GMP experience or familiarity with FDA regulatory requirements are far more likely to clear internal hiring bars that support the sponsorship process.
Apply well ahead of the H-1B registration window
H-1B registration opens in early March each year. To be considered, you need to have an offer in place before then. Start targeting Sharp Sterile Manufacturing roles in the fall or early winter to give yourself enough runway before the deadline.
Filter for verified sponsors before you apply
Not every pharma company that looks promising actually sponsors visas. Migrate Mate surfaces verified sponsors so you can filter by real sponsorship history, saving time and ensuring Sharp Sterile Manufacturing roles you find are confirmed for international applicants.
Frequently Asked Questions
Does Sharp Sterile Manufacturing sponsor H-1B visas?
Yes, Sharp Sterile Manufacturing sponsors H-1B visas. The company has a track record of supporting H-1B petitions for roles in its sterile pharmaceutical manufacturing operations, particularly in technical and scientific functions. If you're targeting Sharp for H-1B sponsorship, aim to secure an offer before early March, when the annual H-1B registration window opens with USCIS.
What visa types does Sharp Sterile Manufacturing sponsor?
Sharp Sterile Manufacturing sponsors H-1B visas for specialty occupation roles, F-1 OPT and F-1 CPT for students and recent graduates, and TN visas for eligible Canadian and Mexican nationals working in qualifying professional categories. The company does not have a recorded history of sponsoring Green Cards or E-3 visas, so international candidates should plan accordingly.
Which departments or roles at Sharp Sterile Manufacturing are most likely to receive visa sponsorship?
Sponsorship at Sharp Sterile Manufacturing tends to align with the technical core of its business: sterile drug manufacturing, quality control, process engineering, regulatory affairs, and analytical sciences. Roles requiring specialized pharmaceutical or biotechnology credentials are the strongest candidates for sponsorship, as these positions are harder to fill without drawing from an international talent pool.
What is the typical application and sponsorship timeline at Sharp Sterile Manufacturing?
The timeline depends on your visa type. For F-1 OPT and CPT, authorization can begin relatively quickly after an offer. For H-1B sponsorship, the process is tied to USCIS's annual cap cycle: registration opens in March, and approved petitions take effect October 1. That means you need an offer in place months before the registration window, making fall and early winter the ideal time to start applying.
How do I find open visa-sponsored jobs at Sharp Sterile Manufacturing?
The most reliable approach is to search on Migrate Mate, which tracks verified sponsorship histories so you can confirm a company's track record before applying. Sharp Sterile Manufacturing's profile on Migrate Mate shows the visa types it sponsors and surfaces current openings, helping you focus your effort on roles where international candidates are genuinely considered rather than sorting through job listings with no sponsorship clarity.