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Director of Quality

3 months ago

Louisville, United States Quicksilver Scientific Full time

Quicksilver Scientific is a leading manufacturer of advanced nutritional systems with a focus on detoxification #liposomedeliverysystem. As a pioneer in the natural health industry, our mission is to deliver on the promise of natural medicine to optimize quality of life.

We envision a company with an environment of collaboration & ideation that leads to innovations that break barriers in the quest for healthier lives. We value:

  • Craftmanship & Integrity our products are crafted with premium ingredients and backed by science.
  • Agility, Audacity & Innovation we pivot and adapt to take chances and lead the way in natural health.
  • Continuous Improvement & Learning constant iteration and improvement is our hallmark.
  • Self-Awareness we strive for self-reflection and authenticity.
  • Mutual Respect, Openness & Exchange our teams work across functions with collaboration and reciprocity.
Our growth is fueled by individuals who share our passion. Currently, we have an opening for a Director of Quality in our Louisville, CO location.

The Director of Quality is responsible for overseeing the Quality Control and Quality Assurance & Regulatory Affairs departments. This includes the development, administration, and communication of quality activities. As well as the implementation and maintenance of procedures and programs in compliance with US FDA regulations and other international standards in our Quality Management System (QMS). This position will be responsible for the continued implementation and maintenance of the QA/RA and QC department's compliance programs and infrastructure, including SOP development/maintenance, document control/change control processes, internal/external audits, deviation review, and tracking, investigations, and corrective and preventative action plans.

Core Responsibilities Include:
  • Responsible for leading the Quality Control, Quality Assurance and Regulatory Affairs teams to ensure the overall quality and continuous improvement strategy for the department, aligning with the overall strategic plan.
  • Leads FDA & other regulatory audits (high priority)
  • Establish quality standards by studying product and customer requirements with other members of management, QA/QC/RA, and Manufacturing.
  • Implement in-process and final product inspection standards by studying manufacturing methods and devising testing methods and procedures.
  • Responsible for managing any quality-related issues with customers and vendors.
  • Lead programs to guarantee that development plans and efforts incorporate the necessary design controls to produce products meeting regulatory standards.
  • Leads management of CAPA, Complaints, Management Review, Document and Records Control, Training, and Internal Audit, approving plans and expenditures necessary to achieve objectives.
  • Build strong quality system infrastructure and resources required for the department to achieve business objectives and scale with the organization.
  • Ensure internal processes and metrics are aligned to create the highest product quality and competitive advantage.
  • Provide leadership and guidance to ensure proper interface between process components of the Quality System.
  • Conduct audits and review performance data to measure productivity and goal achievement to determine areas needing improvement.
  • Manage interactions with vendors, suppliers, and FDA inspectors concerning the quality of products, systems, and processes.
  • Identify and manage continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements.
  • Maintain awareness of current government regulations to apply and implement these regulations to ensure compliance.
  • Establish metrics to evaluate and monitor the effectiveness of the quality system, conduct quality system management reviews.
  • Research and present any new technology implementation/methods/systems/tools that may improve overall quality and efficiency.
  • Interface with Manufacturing, Sales and Marketing to maintain awareness of Quality Systems' operations and activities.
  • Oversee CAPA (corrective action/preventive action) program to ensure the appropriate responses to deviation or audit deficiencies.
  • Assure that all cGMP requirements are met through compliance to government regulations, industry standards, and company specification policies.
  • Review and approve Quality Management System (QMS) documents related to assigned client projects, such as SOPs, Material and Product Specifications, Master Production Records, Validation Protocols and Reports, etc.
  • Issue Primary and Secondary Product Labels based on the approved Master Product Labels.
  • Perform facility release activities for assigned client projects.
  • Perform on-the-floor Quality inspections for critical manufacturing operations.
  • Review and approve executed Batch Production Records and associated Personnel and Environmental Monitoring Records.
  • Manage the Batch-Related Deviation investigations, evaluating Root Cause Analysis results and CAPA responses and providing investigation management support to investigators and CAPA owners.
  • Review the in-process and lot release test results and manage the release of the assigned client product based on the approved Product Specification.
  • Enable sustainable compliance with Regulatory Affairs team in international quality standards and applicable programs and initiatives; proactively identify compliance issues/risks, within the organization and with its external partners, and regularly report to management on compliance activities and findings.
Qualifications:
  • 10+ years of experience in a Regulatory, QA, or QC role
  • Experience in the following areas: SOPs, Lot/Batch Release, Internal/Supplier Audits, Facility Release, Deviation Management, and Regulatory Affairs.
  • Strong understanding of cGMP and FDA regulations.
  • Must be innovative, results-driven, forward-thinking, high-energy, results-oriented, and able to thrive in a fast-paced/evolving environment.
  • Excellent leadership skills, including the ability to develop trust and credibility, lead by example, and motivate high-performing teams.
  • Strong project management and communication skills with an aptitude for building relationships with professionals of all organizational levels.
  • Communicate effectively with other departments within the organization and function within a team environment.
Ideal Candidates have the following traits:
  • Bachelor's degree in chemistry, science, engineering, or related field
  • Strong Investigation and Root Cause Analysis skills.
  • Experience with reviewing validation records and ability to analyze data for accuracy and correctly interpret results.
  • ERP experience
  • Intermediate to advanced proficiency in MS Office
Compensation: $90,000 to $120,000 + annual discretionary bonus

Quicksilver offers a competitive benefits package including:
  • Employer paid Medical, Dental, Life insurance, Short-term & Long-term Disability
  • 401(k) with company matching.
  • Generous paid time off
  • Paid company holidays
  • Paid Parental Leave
  • Fitness Center membership
  • Generous employee discount program on all Quicksilver products

Position Closing Date: 07/25/2024

Location: Onsite

Equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

This job posting is in compliance with the Colorado "Equal Pay for Equal Work Act."