Quicksilver is a pioneer in the natural health industry. Our mission is to deliver on the promise of natural medicine, delivering products that help individuals achieve mind and body health through nature inspired innovation. Our growth is fueled by individuals who share our passion. Currently, we have an opening for a Director of Quality Systems in our Louisville, CO location.
The Director of Quality Systems is responsible for managing the development, administration, and communication of Quality activities and implementation and maintenance of Quicksilver's Quality Management System (QMS) procedures and programs in compliance with US FDA Regulations and other international standards. The person will be responsible for the continued implementation and maintenance of the Quality Systems 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:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Responsible for leading the Quality Assurance, Quality Control and Regulatory Affairs teams to ensure the overall quality and continuous improvement strategy for the department; aligning with Quicksilver's overall strategic plan.
- 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 Quicksilver customers and vendors.
- Lead programs to guarantee that development plans and efforts incorporate the necessary design controls to produce products meeting regulatory standards.
- Organize, oversee and lead 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 department to achieve business objectives and scale with the organization.
- Ensure internal processes and metrics are aligned to create highest product quality and competitive advantage.
- Provide leadership and guidance to ensure proper interface between process components of the Quality System.
- Oversee cGMP testing to assure conformance with protocols, policies and cGMP regulations.
- Plan and conduct audits and inspection readiness of manufacturing and release sites.
- Conduct audits and review performance data to measure productivity and goal achievement to determine areas needing improvement.
- Assess and advise Executive Management on quality decisions.
- 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, and interfaces with Regulatory Affairs to apply and implement these regulations to assure 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.
- Review and provide final approval of all SOPs.
- Review and provide final approval for batch record documentation.
- Monitor production process.
- Assure that all cGMP requirements and 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 managing 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.
- Perform other duties as assigned.
Qualifications:
- Bachelor's degree in chemistry, science, engineering or related field
- 7+ years' experience in a QA management role within a cGMP environment with experience in the following areas: SOPs, Lot/Batch Release, Internal/Supplier Audits, Facility Release, Deviation Management and Regulatory Affairs
- Strong Investigation and Root Cause Analysis skills
- Strong understanding of cGMP and FDA regulations
- 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
Ideal Candidates have the following traits:
- Master's Degree in related field
- 10+ years' in a management role for Quality Assurance Department or previous Director-level experience
- 10+ years' experience in food, pharmaceutical or dietary supplement manufacturing
- Experience working in a clean room setting
- 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.
- Ability to function well in a high-paced and at times stressful environment.
- Coach team leaders on leadership development and assist in creating development and training plans.
- Develop and oversee a quality management system in compliance with regulations for Quicksilver activities; lead implementation and ensure effectiveness across departments
- Communicate effectively with other departments within the organization and function within a team environment.
- Detail-oriented with strong verbal and written communications skills; demonstrated ability to manage multiple projects/tasks.
Quicksilver offers a competitive benefits package including:
- Employer paid Medical, Dental and Life insurance, including Short-term and Long-term Disability
- 401(k) with company matching
- Paid Time Off
- Paid company holidays
- Paid Parental Leave
- Fitness Center membership
- Generous employee discount program on all QS products
Compensation: $100,000 per year to $130,000 per year
Quicksilver Scientific is an 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."