What are the responsibilities and job description for the Quality Systems Manager (medical devices and pharma) position at Systems Ally?
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Position Summary:
The Manager, Quality Systems is responsible for providing quality assurance leadership and oversight across regulated manufacturing operations, including pharmaceutical products, medical devices, biologics, cosmetics, and combination products.
This role supports the organization’s strategic quality objectives by ensuring that quality systems, processes, and compliance activities meet corporate policies and applicable global regulatory requirements. The Manager will translate quality strategy into tactical execution, ensuring end-to-end compliance from raw material receipt through final product release and distribution.
Key ResponsibilitiesQuality Systems Leadership
- Provide QA oversight and support for core quality systems, which may include:
- Document Control / Document Center
- Device Quality Assurance
- Labeling Quality & Compliance
- Validation (CSV, equipment, process, and system validation)
- Training systems and compliance
- Quality Intelligence / Metrics / Reporting
- Ensure quality systems are compliant with corporate policies, FDA regulations, ISO standards, and other global regulatory requirements.
Regulatory Compliance & Risk Management
- Ensure all product-, process-, and system-related quality activities comply with applicable regulations from raw material inspection through shipment of finished goods.
- Support regulatory inspections, audits, and internal assessments, including:
- FDA, ISO, and other health authority audits
- Internal audits and supplier audits
- Assess and mitigate quality risks impacting product quality, patient safety, and regulatory compliance.
Strategic & Tactical Execution
- Translate quality strategy, regulatory updates, and business objectives into actionable plans and tactical deliverables.
- Drive continuous improvement initiatives across quality systems and processes.
- Partner with cross-functional teams (Manufacturing, Engineering, R&D, Regulatory Affairs, Supply Chain) to ensure quality objectives are aligned with business goals.
Operational Support
- Review, approve, and oversee quality documentation including SOPs, work instructions, validation documentation, and labeling materials.
- Support investigations, deviations, CAPAs, change controls, and product impact assessments.
- Ensure effective training systems are in place and maintained to meet regulatory expectations.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related technical discipline
- 7 years of experience in Quality Assurance or Quality Systems within a regulated industry
- 3 years in a leadership or managerial role within QA or Quality Systems
- Hands-on experience supporting pharmaceutical, medical device, biologics, or combination product manufacturing
- Strong working knowledge of:
- FDA regulations (21 CFR Parts 210, 211, 820, 11)
- ISO standards (e.g., ISO 13485)
- Global GMP and quality system requirements
- Proven ability to translate regulatory and quality strategy into operational execution
Preferred Qualifications
- Experience supporting multiple product types (pharma, medical devices, biologics, combination products)
- Experience with validation programs (CSV, equipment, process validation)
- Familiarity with electronic quality management systems (eQMS) and document management tools
- Experience leading or supporting regulatory inspections and audit readiness
- Strong data-driven mindset with experience in quality metrics and quality intelligence
Key Skills & Competencies
- Quality Systems & Compliance Leadership
- Regulatory Inspection Readiness
- Risk-Based Decision Making
- Cross-Functional Collaboration
- Strategic Thinking with Tactical Execution
- Strong Communication & Stakeholder Management
- Continuous Improvement & Operational Excellence
Job Type: Contract
Pay: $60.00 - $100.00 per hour
Work Location: In person
Salary : $60 - $100