Manager, Quality Systems & Administration (Biotech)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Manager, Quality Systems & Administration (Biotech): Managing and administering Veeva electronic Document and Quality Management systems to ensure compliance with cGMP and GxP requirements. Focus on system configuration, access management, user support, and maintaining operational integrity of quality workflows in a fast-paced biotech environment.
Location: Must be based in North Dartmouth, MA
Salary: $110,000 - $145,000 USD
Company
is a fully integrated, commercial-stage biotechnology company focused on developing treatments for central nervous system and immunology conditions.
What you will do
- Perform business administration for Veeva Quality Management Systems including user roles, permissions, and access controls.
- Provide configuration support for Veeva Vault modules, managing document lifecycles, workflows, and metadata.
- Manage electronic signature workflows and document uploads to support cross-functional departments.
- Support user training, onboarding, and the creation of training plans in alignment with departmental needs.
- Participate in regulatory inspections, internal audits, and supplier audits as required.
- Identify and implement opportunities to enhance system usability and workflow efficiency.
Requirements
- Bachelor’s degree or higher required.
- 8+ years of experience in the biotech/pharmaceutical industry, with at least 4 years in a Quality Management Systems function.
- Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience.
- Working knowledge of GxP processes including document change control, deviation management, and CAPA.
- Must be authorized to work in the US; no sponsorship provided.
- Ability to travel up to 10% of the time.
Nice to have
- Experience managing document archival rooms and off-site storage procedures.
- Experience executing test scripts for system updates and releases.
- Proficiency with Veeva PromoMats or other EDMS/QMS/LMS systems.
Culture & Benefits
- Comprehensive medical, dental, and vision insurance.
- Retirement savings 401k with company match and annual discretionary stock options.
- Generous paid time off, sick time, and paid holidays.
- Career development and training opportunities.
- Supportive environment with pet insurance and employee assistance programs.
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