H-1B Visa Quality Systems Manager Jobs
H-1B visa jobs for Quality Systems Manager roles are available at manufacturers, medical device companies, pharmaceutical firms, and aerospace contractors that file Labor Condition Applications with the DOL. The role typically qualifies as a specialty occupation, requiring a bachelor's degree in engineering, quality science, or a closely related field.
Find H-1B Visa Quality Systems Manager JobsOverview
Showing 5 of 33+ Quality Systems Manager jobs
See all 33+ Quality Systems Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Systems Manager roles.
Get Access To All JobsINTRODUCTION
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
The Quality Systems Manager is responsible for managing day-to-day GxP document control processes, ensuring controlled documents and quality records are compliant with regulatory requirements, internal standards, and company procedures.
This role reports to the Senior Manager of Quality Systems and acts as a subject matter expert and collaborates with cross-functional teams to support the document lifecycle, drive process improvements, maintain inspection readiness, and promote compliance with quality system requirements.
Responsibilities
- Manage day-to-day document control operations and ensure controlled documents are maintained throughout their lifecycle in the electronic document management system (e.g., SOPs, Policies, Work Instructions, Forms) in compliance with Business Process and GxP requirements.
- Serve as a subject matter expert for the electronic document management system, including document workflows, user support, testing, and implementation of system enhancements as applicable.
- Partner with document authors, reviewers, approvers, and cross-functional stakeholders to facilitate timely document review, approval, issuance, periodic review, and retirement activities.
- Support the development, maintenance, and continuous improvement of document control procedures, standards, templates, and best practices to support an effective Quality Management System.
- Provide guidance and training to document authors, collaborators, reviewers, and approvers on GxP documentation practices, document management processes, and electronic document management system functionality.
- Demonstrated ability to develop, deliver, and facilitate end-user training for Electronic Document Management Systems (EDMS), including creating training materials and user guides.
- Monitor and report document control metrics, identify trends, and recommend process improvements to enhance efficiency, compliance, and document quality.
- Support change controls, CAPAs, deviations, and continuous improvement initiatives related to document control processes.
- Support internal audits, external audits, and regulatory inspections by providing documentation, records, and subject matter expertise related to document control systems.
- Ensure document control processes remain inspection-ready and compliant with applicable FDA, EMA, ICH, and other GxP regulatory requirements.
- Provide Training coverage as needed.
SKILLS & QUALIFICATIONS
- Bachelor's degree in Life Sciences, Quality, Business, or a related discipline, or equivalent combination of education and experience.
- 6+ years of experience in Document Control and Quality Systems within a regulated GxP environment.
- Demonstrated experience managing document control processes and electronic document management systems.
- 2+ years of recent experience administering Veeva Vault QualityDocs and Vault Training.
- Strong knowledge of FDA, EMA, ICH, and applicable GxP regulations governing quality documentation.
- Experience supporting regulatory inspections, customer audits, and internal audits.
- Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word for document formatting and template management.
- Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Strong written, verbal, and interpersonal communication skills with a collaborative, customer-focused approach.
- Experience with quality metrics, process improvement, and inspection readiness preferred.
Pay Range:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
- We do not conduct job interviews through non-standard text messaging applications.
- We will never request personal information such as banking details until after an official offer has been accepted and verified.
- We will never request that you purchase equipment or other items when interviewing or hiring.
- If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com.
Cytokinetics is an Equal Opportunity Employer
INTRODUCTION
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
The Quality Systems Manager is responsible for managing day-to-day GxP document control processes, ensuring controlled documents and quality records are compliant with regulatory requirements, internal standards, and company procedures.
This role reports to the Senior Manager of Quality Systems and acts as a subject matter expert and collaborates with cross-functional teams to support the document lifecycle, drive process improvements, maintain inspection readiness, and promote compliance with quality system requirements.
Responsibilities
- Manage day-to-day document control operations and ensure controlled documents are maintained throughout their lifecycle in the electronic document management system (e.g., SOPs, Policies, Work Instructions, Forms) in compliance with Business Process and GxP requirements.
- Serve as a subject matter expert for the electronic document management system, including document workflows, user support, testing, and implementation of system enhancements as applicable.
- Partner with document authors, reviewers, approvers, and cross-functional stakeholders to facilitate timely document review, approval, issuance, periodic review, and retirement activities.
- Support the development, maintenance, and continuous improvement of document control procedures, standards, templates, and best practices to support an effective Quality Management System.
- Provide guidance and training to document authors, collaborators, reviewers, and approvers on GxP documentation practices, document management processes, and electronic document management system functionality.
- Demonstrated ability to develop, deliver, and facilitate end-user training for Electronic Document Management Systems (EDMS), including creating training materials and user guides.
- Monitor and report document control metrics, identify trends, and recommend process improvements to enhance efficiency, compliance, and document quality.
- Support change controls, CAPAs, deviations, and continuous improvement initiatives related to document control processes.
- Support internal audits, external audits, and regulatory inspections by providing documentation, records, and subject matter expertise related to document control systems.
- Ensure document control processes remain inspection-ready and compliant with applicable FDA, EMA, ICH, and other GxP regulatory requirements.
- Provide Training coverage as needed.
SKILLS & QUALIFICATIONS
- Bachelor's degree in Life Sciences, Quality, Business, or a related discipline, or equivalent combination of education and experience.
- 6+ years of experience in Document Control and Quality Systems within a regulated GxP environment.
- Demonstrated experience managing document control processes and electronic document management systems.
- 2+ years of recent experience administering Veeva Vault QualityDocs and Vault Training.
- Strong knowledge of FDA, EMA, ICH, and applicable GxP regulations governing quality documentation.
- Experience supporting regulatory inspections, customer audits, and internal audits.
- Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word for document formatting and template management.
- Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Strong written, verbal, and interpersonal communication skills with a collaborative, customer-focused approach.
- Experience with quality metrics, process improvement, and inspection readiness preferred.
Pay Range:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
- We do not conduct job interviews through non-standard text messaging applications.
- We will never request personal information such as banking details until after an official offer has been accepted and verified.
- We will never request that you purchase equipment or other items when interviewing or hiring.
- If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com.
Cytokinetics is an Equal Opportunity Employer
See all 33+ H-1B Visa Quality Systems Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Quality Systems Manager Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Systems Manager
Map your credentials to specialty occupation standards
Pull up O*NET for Quality Systems Manager and confirm your degree aligns with the field-specific requirements USCIS uses to evaluate specialty occupation status. A degree in industrial engineering, quality management, or a physical science strengthens your petition more than a general business degree.
Verify prevailing wage before accepting an offer
Run your target city and job title through OFLC Wage Search before salary negotiations close. Your employer's LCA must certify wages at or above the prevailing level for your worksite, and accepting below that rate creates a compliance problem during USCIS review.
Target employers with active LCA filing history
Search Migrate Mate to identify employers with verified H-1B visa LCA filing history for quality and compliance roles. Companies in regulated industries like medical devices or aerospace file consistently and already understand the documentation burden your petition requires.
Confirm each worksite appears on its own certified LCA
Quality Systems Managers often support multiple facilities. If your role involves regular duties at a site not listed on the original certified LCA, your employer must file a new LCA for that location before you work there to stay compliant with DOL requirements.
Align your resume to audit and regulatory system depth
Employers sponsoring H-1B petitions for this role need documentation that your position requires at least a bachelor's degree. Emphasize ISO standards experience, CAPA systems ownership, and regulatory submissions like FDA 510(k) or AS9100 to anchor the specialty occupation argument.
Use the 60-day grace period strategically between roles
If your current H-1B employer ends your position, USCIS allows a 60-day grace period to secure a new sponsoring employer. File the new I-129 petition before that window closes, since your work authorization ends when the grace period expires, not when you resign.
H-1B Visa Quality Systems Manager: Frequently Asked Questions
Does a Quality Systems Manager role qualify as an H-1B specialty occupation?
Yes, it typically qualifies when the position requires a bachelor's degree or higher in a directly related field such as industrial engineering, quality engineering, or a physical science. Employers must document in the I-129 petition that the role's duties require that theoretical and practical knowledge. Generic management experience without degree-level technical requirements will not satisfy USCIS's specialty occupation definition.
Which industries sponsor H-1B visas most consistently for Quality Systems Manager roles?
Medical device manufacturers, pharmaceutical companies, aerospace and defense contractors, and automotive suppliers file LCAs for Quality Systems Manager roles most regularly. These industries operate under strict regulatory frameworks like FDA, ISO 13485, AS9100, and IATF 16949, which require dedicated quality professionals with degree-level credentials. Migrate Mate lets you search for employers with verified H-1B filing history in these sectors by role and location.
Can my H-1B transfer to a new employer if I change quality systems roles?
Yes. Under H-1B portability rules, you can begin working for a new sponsoring employer as soon as the new I-129 petition is filed, without waiting for USCIS approval, provided you've been in valid H-1B status and the petition is non-frivolous. The new employer must file a fresh LCA certified for the new worksite and wage level before submitting the I-129.
How does the LCA process work for Quality Systems Managers who travel between facilities?
Each primary worksite where you perform H-1B duties must be listed on a certified LCA before you work there. Short-term placements under 60 days in a 12-month period at non-listed sites may qualify for a DOL short-term placement exception, but regular or indefinite work at an unlisted site requires a new certified LCA. Document your worksite arrangements clearly with your employer's HR team before travel assignments begin.
How long does H-1B status last for a Quality Systems Manager position?
Initial H-1B status is granted for up to three years and can be extended to a maximum of six years. Extensions beyond six years are possible only if a PERM labor certification or I-140 immigrant petition has been pending for more than 365 days or an approved I-140 exists. Plan your green card timeline early if you intend to stay in the role long-term.