Sr. Director of Quality

Elevation Labs•Denver, CO

About The Position

JOB SUMMARY: Under the leadership of the Site Leader, the Sr. Director of Quality will participate as a member of Site management team, in formulating and establishing a product quality assurance program, standard operating procedures (SOP's), organizational policies, and levels of regulatory compliance for the company. Additionally, this role will provide strategic leadership and oversight across all facilities including uniformity in quality practices, regulatory compliance, and continuous improvement initiatives across the organization. ESSENTIAL DUTIES AND RESPONSIBILITIES (Site Specific): Develop, implement, and coordinate a comprehensive product quality assurance program to prevent or eliminate defects in new or existing products, including incoming raw materials, packaging components, process water, bulk product batches, and finished goods. Communicate customer product specifications and requirements; evaluate and propose alternative methods and procedures to address challenges and ensure compliance. Develop, implement, revise, and audit Standard Operating Procedures (SOPs) in alignment with customer compliance requirements. Conduct management and training sessions with applicable personnel to establish, review, and reinforce SOPs and organizational policies. Lead and actively participate in Lean Manufacturing initiatives, including Kaizens, Root Cause Analyses (RCAs), Gemba walks, and other continuous improvement activities. Ensure SOPs comply with governing regulations (FDA, ATF, OSHA, and other state/local agencies); review technical issues and recommend procedural improvements. Assist with submission of required regulatory documents and reports to applicable agencies. Review, audit, and approve all Master Formulas and Production Batch Tickets for accuracy. Evaluate suspect or contaminated batches using approved microbiological methods; ensure proactive testing protocols to prevent contamination. Investigate customer complaints and non-conformance issues related to Production and Quality Control; implement Corrective and Preventive Actions (CAPAs). Provide daily direction for the team, including goal setting, staffing, and system health verification. Manage regulatory and customer compliance inspections and facility audits. Conduct risk-based internal audits; develop and implement CAPAs based on audit findings. Collaborate with senior management on financial decisions and budget planning for the Quality Assurance Department. Additional Corporate Responsibilities: Develop and enforce global quality policies and procedures aligned with FDA regulations and international standards (e.g., ISO 22716). Elevation Labs provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Elevation Labs complies with applicable state and local laws governing nondiscrimination in employment at every location in which the Company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Lead cross-site internal audits and supplier quality audits to ensure GMP compliance and mitigate regulatory risks. Standardize and manage the company-wide Quality Management System (QMS), including document control, CAPAs, deviations, and change control. Oversee or support regulatory inspections and coordinate consistent site readiness efforts. Provide training and development for plant-level quality staff to maintain compliance and competency. Analyze quality metrics across all sites to identify trends, drive root cause analysis, and implement best practices. Serve as liaison with external regulatory bodies and provide strategic guidance on regulatory intelligence and evolving standards. Incumbents may be asked to perform other duties as assigned.

Requirements

Knowledge of Good Manufacturing Practices (cGMPs) is required
Experience and knowledge in Cosmetic, Personal Care, OTC drug, and Medical Device regulations with FDA, Health Canada, and other Foreign Markets
Knowledge of ISO standards, specifically ISO22716, ISO22718 and ISO13485
Flexibility and ability to manage multiple tasks in a short amount of time.
Ability to perform basic mathematical calculations (addition, subtraction, multiplication, division, percentages, etc.).
Performs work using good organizational and time management skills.
Performs work with a high degree of accuracy and attention to detail.
Communicates by written and/or verbal means the nature of out-of-specification test results.
Works with minimum supervision.
College degree (A.S. or B.S.) and 10 years of quality control and/or microbiology lab experience. Bachelor's degree in science and/or engineering is preferred.
Five years' related experience in a production or manufacturing environment (cosmetics, food, bottling, etc)
Previous experience working in a GMP environment preferred.

Nice To Haves

Bilingual in Spanish a plus.

Responsibilities

Develop, implement, and coordinate a comprehensive product quality assurance program to prevent or eliminate defects in new or existing products, including incoming raw materials, packaging components, process water, bulk product batches, and finished goods.
Communicate customer product specifications and requirements; evaluate and propose alternative methods and procedures to address challenges and ensure compliance.
Develop, implement, revise, and audit Standard Operating Procedures (SOPs) in alignment with customer compliance requirements.
Conduct management and training sessions with applicable personnel to establish, review, and reinforce SOPs and organizational policies.
Lead and actively participate in Lean Manufacturing initiatives, including Kaizens, Root Cause Analyses (RCAs), Gemba walks, and other continuous improvement activities.
Ensure SOPs comply with governing regulations (FDA, ATF, OSHA, and other state/local agencies); review technical issues and recommend procedural improvements.
Assist with submission of required regulatory documents and reports to applicable agencies.
Review, audit, and approve all Master Formulas and Production Batch Tickets for accuracy.
Evaluate suspect or contaminated batches using approved microbiological methods; ensure proactive testing protocols to prevent contamination.
Investigate customer complaints and non-conformance issues related to Production and Quality Control; implement Corrective and Preventive Actions (CAPAs).
Provide daily direction for the team, including goal setting, staffing, and system health verification.
Manage regulatory and customer compliance inspections and facility audits.
Conduct risk-based internal audits; develop and implement CAPAs based on audit findings.
Collaborate with senior management on financial decisions and budget planning for the Quality Assurance Department.
Develop and enforce global quality policies and procedures aligned with FDA regulations and international standards (e.g., ISO 22716).
Lead cross-site internal audits and supplier quality audits to ensure GMP compliance and mitigate regulatory risks.
Standardize and manage the company-wide Quality Management System (QMS), including document control, CAPAs, deviations, and change control.
Oversee or support regulatory inspections and coordinate consistent site readiness efforts.
Provide training and development for plant-level quality staff to maintain compliance and competency.
Analyze quality metrics across all sites to identify trends, drive root cause analysis, and implement best practices.
Serve as liaison with external regulatory bodies and provide strategic guidance on regulatory intelligence and evolving standards.
Incumbents may be asked to perform other duties as assigned.