Albion Rye Associates · 4 hours ago
Quality System Manager
United States
Full-time
Remote
Senior Level
$120K/yr - $150K/yr
5+ years exp
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Hiring Manager
Megan Siggins
Insider Connection @Albion Rye Associates
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Responsibilities
Lead and promote the site’s quality culture, policies, and procedures, identifying opportunities for continuous improvement in Quality Management Systems.
Prepare, review, and approve QA-related documents in alignment with approved SOPs and standards.
Ensure timely closure of organizational tasks, including tracking and escalating open items, managing timelines, and reporting quality metrics (e.g., Investigations, CAPAs, Complaints, Change Controls, Effectiveness Checks, Trends).
Ensure the site’s quality standards, practices, and documentation meet regulatory, industry, and pharmacopoeia standards, adapting them as necessary to organizational needs.
Support regulatory and client inspections, ensuring continuous inspection readiness.
Monitor, manage, and improve site Quality Assurance KPIs.
Assess and approve quality system documents (e.g., investigations, complaints, change controls) for GMP compliance and regulatory adherence.
Collaborate to address and resolve compliance issues effectively.
Represent QA in internal and external meetings, providing quality expertise and guidance.
Monitor training completion to ensure personal and departmental compliance with required standards.
Guide and manage team members and activities, fostering a collaborative and high-performing environment.
Interface professionally with internal and external stakeholders, maintaining a customer-centric approach.
Qualification
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Required
Bachelor’s degree in a relevant field or equivalent combination of education, training, and experience
Minimum of 5 years of relevant work experience in Quality Assurance or a GMP-regulated industry
At least 2 years of leadership experience, building and managing high-performing teams
Strong experience in managing technical issues using structured analysis methodologies
Familiarity with electronic Quality Management Systems (e.g., MasterControl, TrackWise Digital)
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, etc.)
Excellent written and verbal communication skills
Strong leadership abilities, fostering effective collaboration across teams
Exceptional organizational skills with the ability to handle deadlines in a high-pressure environment
Problem-solving expertise, including data analysis and resolution of complex issues
Comprehensive understanding of CGMPs and industry standards
Familiarity with regulatory requirements for drug substances and products
Preferred
Master’s degree in Life Sciences, Pharmacy, Engineering, Industrial Management, Business Administration, or Operations
Company
Albion Rye Associates
Albion Rye Associates are global single sector, life sciences recruitment experts, dedicated to supporting clients in their mission to positively impact, and improve patient lives globally.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
