VP of Quality and Technical Operations

SummaryThe Vice President of Quality and Technical Operations oversees the strategic direction of the companys quality program and provides leadership and technical expertise to ensure that all products meet the companys product specifications, cost and service objectives, and overall product quality standards. Additionally, is responsible for leading a highly motivated Quality team of GHW Corporate Quality, Quality Assurance, and GBW Quality; responsible for Product Quality, Supplier Quality, support new product development, Contract Manufacturer interaction, continuous improvement support, and quality systems execution. Key ResponsibilitiesDevelop and execute a comprehensive quality assurance strategy aligned with the company's objectives. Build and maintain a collaborative relationship with the senior leadership teams and vendors to support and aid in implementing all quality programs.

Oversee the design, implementation, and maintenance of robust quality management systems, including document control, deviation management, CAPA (Corrective and Preventive Action), change control, audits, and quality assessments, ensuring readiness and compliance with FDA, EMA, and other regulatory agencies.

Drive quality risk management initiatives, identifying and mitigating potential risks to product quality, patient safety, and regulatory compliance.

Drive initiatives to monitor and improve customer satisfaction levels. Implement feedback mechanisms and take corrective actions to address customer concerns related to product quality.

Define key performance indicators (KPIs) for quality assurance and develop systems for tracking and reporting on quality metrics.

Stay abreast of evolving regulations, industry trends, and best practices in quality assurance and proactively implement necessary changes to maintain compliance and drive continuous improvement.

Direct and manage activities related to process and product compliance with applicable laws and regulationsCollaborate with cross-functional teams, including product development, science, manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality assurance processes throughout the product lifecycle.

Establish and oversee the companys stability program for all products across business lines.

Review, implement, and enforce departmental SOPs as needed.

Lead and mentor in meetings with the US FDA and other regulatory agencies, third-party inspections, and audits.

Oversee quality audits and reports and manage corrective action plans.

Set performance measures to monitor the business units quality performance.

Assist in all areas of formulation development and technical services for products in the supplement marketProvide technical assistance for new products, packaging, and processes.

Identify issues and challenges, measure and confirm results, implement solutions, and develop control plans to ensure continuation of improvement.

Perform other duties as assigned.

Minimum Education and ExperienceMust have a Bachelors Degree in quality management, life sciences, engineering, business, or appropriate equivalent from an accredited universityMinimum of 20 + years hands-on work experience in a related industry; dietary supplement or consumer products industries preferred8 + years of nutraceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience.

Must have experience leading teams, projects, programs or directing the allocation of resourcesMust have strong working knowledge of applicable cGMP guidelines and The Federal Food, Drug, and Cosmetic Act (FFDCA)Strong computer skills, including Microsoft business applications and various reporting softwareMust have strong project management, business writing, and reporting skills Knowledge, Skills, and AbilitiesExcellent written and verbal communication skillsAbility to read, analyze, and interpret common information, reports, and other documentsUnderstand state and federal requirements for manufacturing, distribution, marketing, and sale of consumer productsAbility to respond to common inquiries or complaints from customers, regulatory agencies, and/or company representativesAbility to effectively present information to management and work cross-functionally across all levels of the organization and with external manufacturing and distribution partnersExperience with relational databases, data validation, and report/query setup is a plusAbility to perform multiple tasks simultaneously, keep accurate recordsPhysical/Work Environment/ExpectationsWhile performing duties of job, incumbent is occasionally required to:

Operate in a professional office environmentConstantly use work-related equipmentTo use hands and fingers to handle or feel objects, tools, or controlsOccasionally lift and/or move up to 25 poundsTo sit for long periods of time (up to 10 hours per day)To lift files, open filing cabinets and bend or stand as necessaryAbility to work regular, full-time schedule, Monday through Friday with the flexibility to work additional hours depending on business demands.

Note:

This job description is not totally inclusive nor it is designed to cover or contain a complete comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.