Senior Quality Systems Specialist

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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 Bachelor's degree in Life Sciences, Quality, or related scientific discipline preferred 2-4+ 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!