The Quality Manager is responsible for the quality systems and functions for our Madison area, Wisconsin facility’s operations. The Quality Manager is responsible for training, developing, and empowering the facility quality team while ensuring consistent proficiency and approach toward process improvements aimed at product quality and regulatory compliance. The Quality Manager demonstrates commitment to GMP compliance, food safety, and continuous improvement, and ensures that quality systems align with and support corporate goals and objectives.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Collaborate closely with operations and R&D teams to ensure proper implementation, sustainability, and compliance of manufacturing processes, food safety programs, and quality systems.
- Identify GMP, food safety, and quality system training needs for the facility, oversee training, and act as SME instructor.
- Lead quality team to ensure products are manufactured according to company policies and in compliance with regulations and customer requirements.
- Conduct batch record reviews; review and release manufacturing work orders per specifications and acceptance activities using the ERP system.
- Write, review, and approve documentation (SOPs, Work Instructions, reports, etc.)
- Oversight of validation activities for manufacturing processes, equipment qualification, cleaning processes, facilities, and laboratory methods to ensure compliance with regulatory requirements and current industry practices.
- Recognize and evaluate changes, including additions or modifications to a validated process/equipment/facility, to determine the need for and the extent of revalidation.
- Support investigation of deviations and unexpected or unusual observations, in both QC and manufacturing.
- Conduct quality investigations, root cause analysis, identification and implementation of corrective/preventive actions.
- Provide technical guidance on the purchase of materials and equipment related to GMP and food safety.
- Direct the supplier quality management program.
- Participate in regulatory inspections, third-party inspections, and customer audits. Conduct follow-ups where corrective action is required.
- Report on quality system performance via the internal quality audit and management review processes.
- Maintain third-party certification compliance: Organic, Kosher, Halal, NSF, etc. as applicable
- Keep the management team informed of significant issues or developments identified during quality assurance activities and the actions being taken to improve the situation.
- Other duties as assigned.
The appropriate knowledge, skills, and abilities required for this position are achievable through the following combination of education, work experience, and training:
- Bachelor’s Degree or higher in microbiology with 5+ years of Quality Assurance experience with increasing levels of responsibility, including 3+ years of direct Quality Management experience.
- Knowledge of regulatory requirements that affect the food, dietary supplement, and/or pharmaceutical manufacturing business, strongly preferred
- HAACP certification preferred
- ASQ CQE- or CQM/OE- certified preferred
- Knowledge of GMP, validations and qualifications, internal auditing, handling of regulatory inspections, change control, deviations, CAPA investigation, verification, and closure
- Hands-on experience in the following:
- Validations and qualifications
- Internal and supplier quality audits
- Regulatory inspections
- Change control
- CAPA investigation, verification, and closure
- Quality supply chain management
- Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications.
- Effectively manage competing priorities and adapt to and manage change with a demonstrated ability to accept additional responsibilities and manage tasks through teamwork.
- Ability to provide direction to employees, establish overall objectives and available resources, and assure that finished work and methods used are technically accurate and in compliance with established requirements.
- Excellent application, communication, organization, planning, problem-solving, and follow-up skills.
- Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
- Occasional travel is required.
To apply, please submit your resume to firstname.lastname@example.org