Quality Manager

Probi•Lafayette, CO

12h•Onsite

About The Position

The Quality Manager leads the Quality Assurance and Quality Control function in Colorado and reports to the Sr. Director of Global Quality. Under the guidance of the Sr Director Global Quality, the Quality Manager is responsible for assessing the current and establishing an improved and effective Quality Management System to ensure the system meets regulatory and industry standards. They utilize an extensive set of quality skills to help drive continuous improvement, ensure the quality attributes of products are met, and develop highly skilled teams. They monitor quality metrics and report these up to senior management. They are the primary point of contact for second- and third-party audits and inspections, testing review and disposition, and customer complaints and investigations. This role forms partnerships with plant leadership to drive the success of the organization. The Quality Manager oversees and manages the quality teams in Lafeyette, which includes Quality Assurance and the Microbiological laboratory.

Requirements

Experience with contract manufacturing of dietary supplements.
Prior experience with hosting regulatory inspections and development of CAPAs to address findings and preparation of formal response.
Good knowledge of best practices in the Natural Health Products Industry.
Prior experience testing and enumerating probiotics.
Must be able to recognize audible and visual hazards.
Ability to read, write, and converse in the English language.
Must follow GMP, PPE, and company safety policies in the performance of job duties.
Must maintain good attendance.
Able to pass a background check.
Proficiency with auditing process (both virtually and on site).
Ability to influence and collaborate effectively with stakeholders at any level of the organization.
Analytical mind, good attention to details and problem-solving skills within a structured process.
Concise and persuasive in the description and resolution of compliance risk.
Understanding of corporate governance processes.
Working understanding of R&D and New Product Development practices and requirements.
Demonstrated application of continuous improvement, change control and risk assessment.
Fluent in English – spoken and written.
Degree (BSc or MSc) or equivalent experience in a relevant technical field.
Minimum of 3 years working with cGMP and GLP regulatory, testing, and manufacturing requirements for ingredients, food, and dietary supplements.
Minimum 3 years of demonstrated experience in microbiology laboratories utilizing plating and enrichment techniques.
Demonstrated knowledge and experience in performing ISO 22,000 audits.
Awareness of ISO 17025 Lab Standards and ISO 9001 Quality Systems standards.
Demonstrated knowledge conducting hazard analysis and establishing risk-based control points.

Responsibilities

Build a high-performing quality team.
Mentor, coach, train, and lead quality personnel.
Perform administrative duties such as scheduling, performance reviews, hiring, budget, etc.
Identify and document risks and gaps applicable regulatory, GMP, GLP, ISO, and/or customer requirements. Keeps management informed about risks and critical non-conformities.
Under guidance from Sr Director Global Quality, assess, recommend and establish an effective Quality Management System governing manufactured products and testing laboratories.
Establish effective laboratory and quality processes to ensure the proper testing and release procedures are in place, including maintaining effective deviation, OOS, and CAPA systems.
Ensure that change control, standardization of work, training, deviations, CAPA, complaints, and audits serve organizational quality objectives and priorities.
Author, revise, and update-controlled documents, such as SOPs, forms, and charts.
Ensure all requisite quality control activities are executed as specified in a timely manner.
Oversee routine testing and analysis to maintain accuracy and precision.
Ensure proper maintenance and calibration of testing equipment.
Review and approve Master Manufacturing Records and Product Specifications.
Oversee the review and disposition of materials to ensure they meet specifications.
Maintain accurate and complete records of all quality and testing activities, ensuring documentation meets regulatory requirements and is readily accessible for audits.
Preparation of clear concise audit reports that ensure mitigation of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
Ensure effective maintenance of Certifications and Standards, including timely responses to findings and opportunities for improvements.
Manage change controls and variations as appropriate.
Investigate customer complaints using systematic methods and properly identify root cause and associated corrective and preventive actions.
Keep current on changes in industry and regulatory standards for GxP requirements and advise on business impact.
Ensure readiness of all quality activities incl. audits and inspections.
Influence multiple stakeholders across Quality, Supply Chain and Product Development & Application departments as well as Suppliers and Customers, hence using a pro-active mindset and ability to work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.

Benefits

Medical, vision, and dental coverage after 30 days (and first day of the following month).
Three (3) plans to choose from.
Long-term and short-term disability insurance at no cost to employee.
PTO (Paid Time Off) accrues on hire with up to 4 weeks (20 days) for new hire and increases the longer you are with the company.
Participation in the company 401(K) and Roth plan after 6 months of employment with up to 4% employer match.
Ten (10) paid holidays.
17 hours per calendar year, to go out and volunteer in your community!
Employee Assistance Program
Yearly Safety shoe vouchers.
Learning and Development Opportunities
Monthly birthday and anniversary celebrations.
Team-building events throughout the year including summer and winter celebrations.