Overview
Remote – Quality Systems Specialist Jobs in United States at Beacon Hill
Title: Remote – Quality Systems Specialist
Company: Beacon Hill
Location: United States
A highly reputable biopharmaceutical corporation is currently hiring a qualified Quality Systems Specialist to work in the United States.
Job Description:
Position Overview
The Specialist of Global Quality Systems will serve as the Process enabler and support for critical quality processes including Deviations, Corrective and Preventive Actions (CAPA), Change Control, Regulatory Intelligence, and Training within a global biotechnology environment.
This role is essential in maintaining quality excellence and regulatory compliance across the enterprise while ensuring processes remain efficient and fit for purpose.
Key Responsibilities
Process Support
Serve as global process support for Deviation, CAPA, Change Control, Reg Intel, and Training processes.
Facilitate analysis of Quality Systems metrics and performance periodically.
Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures.
Oversee Regulatory Intelligence assessments and maintain associated documentation.
Facilitate the Change Control Review Board and maintain associated documentation.
Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification.
Support development of Quality related training content.
Support quality systems audits and regulatory inspections.
Provide guidance and support to site quality teams in process implementation.
Qualifications
Required Experience & Skills
Bachelor’s Degree in Life Sciences, Engineering, or related field
2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries
1+ year of experience in manufacturing, operations, or related business areas
Demonstrated experience in process ownership and quality systems management
Strong understanding of GMP, GLP, GCP regulations and ICH guidelines
Experienced with electronic quality management systems (Veeva)
Preferred Qualifications
Master’s Degree in related field
ASQ certification (CQA, CQM)
Experience with Lean Six Sigma methodologies
International work experience
Experience with change management and organizational development
Key Competencies
Strong process thinking and analytical skills
Strong experience in Excel
Excellence in project management and organization
Outstanding communication and presentation abilities
Proven ability to influence without direct authority
Strong facilitation and training skills
