VP of Quality and Technical Operations

Great HealthWorks, Inc.•Fort Lauderdale, FL

5d•Onsite

About The Position

The Vice President of Quality and Technical Operations oversees the strategic direction of the company’s quality program and provides leadership and technical expertise to ensure that all products meet the company’s 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.

Requirements

Must have a Bachelor’s Degree in quality management, life sciences, engineering, business, or appropriate equivalent from an accredited university
Minimum of 20 + years hands-on work experience in a related industry; dietary supplement or consumer products industries preferred
8 + 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 resources
Must 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 software
Must have strong project management, business writing, and reporting skills
Excellent written and verbal communication skills
Ability to read, analyze, and interpret common information, reports, and other documents
Understand state and federal requirements for manufacturing, distribution, marketing, and sale of consumer products
Ability to respond to common inquiries or complaints from customers, regulatory agencies, and/or company representatives
Ability to effectively present information to management and work cross-functionally across all levels of the organization and with external manufacturing and distribution partners
Ability to perform multiple tasks simultaneously, keep accurate records

Nice To Haves

Experience with relational databases, data validation, and report/query setup is a plus

Responsibilities

Develop 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 regulations
Collaborate 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 company’s 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 unit’s quality performance.
Assist in all areas of formulation development and technical services for products in the supplement market
Provide 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.