Senior Quality Systems Specialist

Connexion Systems + Engineering

Remote, USA, MA(remote)

Apply

JOB DETAILS

SALARY

$65–$75 Per Hour

SKILLS

Biology, Biotech and Pharmaceutical, Change Control, Communication Skills, Compensation and Benefits, Computer Systems, Consulting, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Quality, Detail Oriented, Document Control, Documentation, File Audits, File Maintenance, GxP, Maintain Compliance, Metrics, Microsoft Excel, Microsoft Office, Microsoft Word, Multitasking, Onboarding, Operational Strategy, Organizational Skills, Process Improvement, Quality Management, Regulatory Compliance, Standard Operating Procedures (SOP), Support Documentation, System Validation, Systems Engineering, Team Player, Validation Documentation

LOCATION

Remote, USA, MA

POSTED

23 days ago

Connexions mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Senior Quality Systems Specialist (Remote)
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

Duration: 6+ month contract to hire
Pay rate: $65-$75/hr (perm salary expectations: $155k - $175k)
Job Location: Remote, USA
Schedule: Mon Fri, EST time zone working hours
Job#: bh19115

Description:
A growing clinical-stage biopharmaceutical organization is seeking a Senior Quality Systems Specialist to support and enhance Quality Management System (QMS) operations in a regulated GxP environment. This is a remote, temp-to-perm opportunity with strong potential for extension or early conversion based on performance.

The role will focus heavily on training administration, document control, audit support, and computer system validation (CSV) documentation activities. The ideal candidate will bring experience in pharmaceutical or biotechnology quality systems and thrive in a fast-paced, inspection-ready environment. Given your recent work drafting roles involving Veeva Vault and regulated clinical operations, this posting keeps the technical detail strong while remaining candidate-friendly for public distribution.

Key Responsibilities

Provide day-to-day support for core QMS processes including:
- Training Management
- Document Control
- Computer System Validation (CSV)
- Audit Program Administration
- CAPA, Deviations, and Change Control support activities
Administer LMS/Veeva-based training activities including:
- Curriculum assignments
- Training compliance monitoring
- Onboarding and transfer training reviews
- Training metrics and inspection-readiness support
Support document control processes including:
- Controlled document formatting and routing
- Approval workflows
- Periodic review coordination
- Archiving and lifecycle management
Assist with audit program activities including:
- Audit scheduling and tracking
- Audit file maintenance
- CAPA and observation follow-up
- Metrics reporting
Support CSV documentation efforts including:
- Validation documentation updates
- Validation package remediation
- Test evidence organization
- Periodic review support
Track QMS records and follow up with stakeholders to ensure timelines and compliance requirements are met
Maintain inspection-ready documentation in accordance with SOPs, GxP standards, and data integrity expectations
Support audits, inspections, and inspection-readiness initiatives
Assist with process improvement initiatives and operational efficiency projects across Quality Systems workstreams

Qualifications

Bachelors degree in Life Sciences, Quality, or related scientific discipline preferred
24+ years of experience in pharmaceutical, biotechnology, or other regulated industries
Experience supporting Quality Systems, Training, Document Control, CSV, or Audit programs
Working knowledge of:
- GxP requirements
- Controlled documentation practices
- Training compliance
- Inspection readiness standards
Experience with electronic QMS platforms preferred, including:
- Veeva Vault QMS
- Veeva QualityDocs
- Veeva Training/LMS
Strong organizational and technical skills with the ability to manage multiple priorities
High attention to detail and strong data integrity mindset
Proficiency with Microsoft Office applications, especially Word and Excel
Strong communication and cross-functional collaboration skills

Ideal Background
Candidates with experience in biotech or pharmaceutical quality environments who have supported training administration, document management, audit readiness, or validation documentation activities will be especially well suited for this role.

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.

You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.

If you are active in a job search but this job is not for you, please reach out to

jobpostings@csetalent.com

. We would be glad to help you find the perfect job!

About the Company

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity. Over the last 20 years Connexion has built the most admired team of staffing experts in the industry. We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

1999

WEBSITE

https://www.csetalent.com/