Quality Systems Manager

Lever, Inc.; Deutschland; Remote; EUR 111.000 - 124.000; Vollzeit

Benefits dieser Stelle

Remote work

Bonus

Off-sites

Great benefits

Career growth

Zusammenfassung

Lever, Inc. is seeking a Quality Systems Manager based in Germany to lead and standardize the corporate QMS across multiple facilities. You will own the QMS, drive governance, and partner with Quality, Operations, Product, Regulatory, and Supply Chain to ensure compliance and continuous improvement.

This remote, high-trust role emphasizes data-driven decision making, CAPA management, document control, and the adoption of Veeva QualityOne to maintain data integrity and reporting across sites.

Qualifikationen

• Experience implementing and improving Quality Management Systems in regulated environments (food, dietary supplements, consumer health)
• 5+ years in Quality Systems or QA with relevant degree
• Knowledge of FDA requirements including 21 CFR Part 111 and cGMPs
• Experience with document control, change control, CAPA, deviations, OOS investigations, and quality metrics
• Experience administering electronic QMS, preferably Veeva QualityOne
• Knowledge of GFSI/SQF is preferred
• Strong communication, organization, analytical, and cross-functional collaboration skills
• Ability to manage multiple priorities and influence without authority
• Certifications in quality systems or CAPA preferred
• Experience and training related to 21 CFR Part 111
• Strong data-driven mindset with ability to identify trends and translate data into improvements

Aufgaben

• Own and continually improve the corporate QMS across facilities
• Guide facility Quality teams to implement corporate requirements
• Manage the corporate Document Control program lifecycle
• Lead the Change Control program with risk assessment and verification
• Manage and support the Food Safety and Quality Training Program
• Serve as business owner and primary QMS admin for Veeva QualityOne
• Develop and support corporate Quality Standards across facilities
• Provide governance for CAPAs, deviations, non-conformances, and OOS events
• Manage complaint trending and quality data analysis for systemic issues
• Support Management Reviews with KPI analysis and QMS performance indicators
• Assist audits by maintaining audit-ready QMS documentation
• Partner with Quality, Operations, Product, Regulatory, and Supply Chain
• Monitor QMS effectiveness and drive improvements
• Provide training and guidance on QMS processes and workflows
• Maintain quality records per regulatory requirements
• Drive harmonization across facilities and escalate major risks

Kenntnisse

Quality systems

Regulatory compliance

Data analysis

Cross-functional collaboration

Ausbildung

Bachelor's in Food Science/Quality/Engineering

Tools

Veeva QualityOne

Jobbeschreibung

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Systems Manager based in Germany.

This is a corporate-level quality leadership role focused on maintaining and continuously improving a standardized Quality Management System across multiple facilities.
You’ll establish quality system requirements, strengthen governance, and help ensure consistent implementation across regulated operations.
The role covers document and change control, training systems, CAPA, deviations, OOS investigations, complaints, audits, and quality metrics.
You’ll use data and quality trends to identify systemic risks, drive corrective actions, and improve operational effectiveness.
Working cross-functionally, you’ll partner with Quality, Operations, Product, Regulatory, Supply Chain, and facility teams.
You’ll also serve as the primary administrator and business owner for an electronic QMS, supporting adoption, workflows, data integrity, and reporting.
The position offers significant ownership and influence in a remote, high-trust environment focused on quality, compliance, and continuous improvement.

Accountabilities

• Own, implement, maintain, and continuously improve the corporate Quality Management System, establishing standardized processes, procedures, governance, and quality expectations across facilities.
• Provide guidance and support to facility Quality teams to ensure corporate requirements are consistently implemented while allowing for appropriate site-specific procedures.
• Manage the corporate Document Control program, including document creation, review, approval, issuance, revision, periodic review, archival, obsolescence, and controlled distribution.
• Lead the Change Control program, ensuring changes are documented, risk-assessed, reviewed, approved, implemented, communicated, and verified for effectiveness.
• Manage and support the Food Safety and Quality Training Program, including learning plans, training matrices, assignments, completion tracking, retraining requirements, and training records.
• Serve as the business owner and primary Quality administrator for Veeva QualityOne, supporting configuration, workflows, user adoption, data integrity, reporting, and continuous improvement.
• Develop, maintain, communicate, and support implementation of corporate Quality Standards, translating requirements into effective facility-level programs and procedures.
• Provide governance and workflow support for CAPAs, deviations, non-conformances, and OOS events, including investigation quality, root cause analysis, action planning, approvals, effectiveness checks, trending, and timely closure.
• Manage complaint trending and quality data analysis to identify recurring issues, emerging risks, systemic trends, and opportunities for corrective or preventive action.
• Support Management Reviews by compiling, analyzing, and presenting QMS performance indicators, CAPA and deviation status, complaint trends, audit observations, training performance, and other relevant quality metrics.
• Support internal, customer, regulatory, and certification audits by maintaining controlled, complete, current, and audit-ready QMS documentation and records.
• Partner with Quality, Operations, Product, Regulatory, Supply Chain, and other stakeholders to integrate quality requirements into business processes, new initiatives, and organizational changes.
• Monitor QMS effectiveness through metrics, trending, periodic reviews, and compliance assessments, recommending improvements based on risks, audit findings, recurring issues, and business needs.
• Provide training, coaching, and technical guidance to facility Quality teams and other stakeholders on QMS processes, documentation, QualityOne workflows, and applicable standards.
• Ensure corporate quality records are properly maintained, retained, protected, and readily retrievable in accordance with regulatory and company requirements.
• Drive harmonization and standardization across facilities while escalating significant compliance, product quality, or food safety risks to Quality leadership.

Requirements

• Demonstrated experience implementing, managing, and improving Quality Management Systems in a regulated food, dietary supplement, consumer health, or related environment.
• 5+ years of Quality Systems or Quality Assurance experience with a bachelor’s degree in Food Science, Quality, Biology, Chemistry, Engineering, or a related field, or an equivalent combination of education and relevant technical experience.
• Working knowledge of applicable FDA requirements, including 21 CFR Part 111, and current Good Manufacturing Practices (cGMPs).
• Experience with document control, change control, training systems, CAPA, deviations, OOS investigations, complaint trending, and quality metrics.
• Experience administering electronic Quality Management Systems, with Veeva QualityOne strongly preferred.
• Knowledge of GFSI/SQF quality and food safety system requirements is preferred.
• Ability to develop corporate quality standards and effectively support their implementation across multiple facilities.
• Strong written and verbal communication, organization, analytical, problem-solving, and cross-functional collaboration skills.
• Ability to manage multiple priorities, drive timely closure of quality activities, and influence stakeholders without direct authority.
• Relevant certifications or formal training in quality systems, auditing, HACCP, SQF/GFSI, root cause analysis, or CAPA are preferred.
• Experience and training related to 21 CFR Part 111.
• Strong data-driven mindset with the ability to identify trends, assess risks, and translate quality information into actionable improvements.

Benefits

• Base salary of $125,000–$140,000 plus bonus, depending on experience.
• Comprehensive benefits package designed to support employee and family well-being.
• Generous paid time off.
• Strong healthcare and benefits coverage for employees and their families.
• Wellness-focused perks and access to company products.
• Fully remote, high-trust work environment.
• Biannual company off-sites providing opportunities to connect with colleagues in person.
• Opportunity for significant ownership and career growth in a quality leadership role.
• Opportunity to work cross-functionally across Quality, Operations, Product, Regulatory, and Supply Chain.
• Environment focused on high standards, ownership, urgent impact, and continuous improvement.

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