Quality Manager (Swisse & Biostime)

A bit about Health & Happiness Group

At Health & Happiness, our vision is focused on premium nutrition and lifetime wellness; to inspire and achieve this vision we bring together seven international brands as we strive to make people around the world healthier and happier. We have established market positions in more than 15 countries in Asia-Pacific, Europe, North America and Oceania with more than 3,400 employees working across the globe. We are excited about our future as we expand these premium, proven and aspirational brands to new markets, greeting consumers in all life stages.

What this means for you

The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life-changing experience as you step into an environment that moves quickly and presents new challenges daily.

Our success as an organization is directly attributed to the health and happiness of our team. As a new team member, you will be empowered to positively contribute to our high-impact culture and be supported in bringing your whole self to work.

Your role within the team

The Quality Assurance & Quality Control Manager is responsible for overseeing operations to ensure compliance to State, Federal, and International regulations while increasing the quality of H&H ANC/BNC products. Duties and responsibilities may include: managing QA/QC personnel, formulating policies, managing daily operations of the Quality team, leading Quality processes, and managing the quality of our internal suppliers and external vendors.

Duties and responsibilities

• Drives, leads, and troubleshoots quality investigations to identify root causes with appropriate corrective actions.
• Audits suppliers and contract manufacturing facilities
• Oversee finished product testing procedures and work with QC to implement procedures and tests deemed appropriate
• Oversee long-term stability testing program
• Identify, design, and implement process and system improvements.
• Drive continuous improvement both internally and manufacturing sites.
• Establishing Quality Agreements with all manufacturing partners and assure that Quality Agreements are adhered to.
• Manage competing priorities and allocate and assigned resources to meet targets and timelines
• Manages QA/QC personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Manage the development, interpretation, and enforcement of Quality Systems as per internal policy and GMP regulations under 21 CFR Part 111, 21 CFR Part 117 and 21 CFR Part 101.
• Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and beyond.
• Responsible for final release of products to distribution.
• Works extensively with manufacturing partners to ensure that requirements and specifications are met.
• Interfaces with manufacturing partners to address and resolve more complex product/process performance issues.
• Works with Product Development during new product launches and establishes key checkpoints for new products and processes.
• May interface with regulatory agencies as required.
• Ensure Quality personnel are adequately trained in order to fulfill quality systems duties as per 21 CFR Part 111 GMP requirements.
• Work proactively to ensure our products quality and performance lead the industry
• Oversee Change Control systems
• Develop, review and approve Standard Operating Procedures (SOPs), Work Instructions, and forms to improve Quality Systems documentation while meeting quality objectives.
• Perform internal audits to existing company Quality Systems procedures and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System.
• Host FDA and third party audits to meet 21 CFR Part 111. Ensure all findings are addressed appropriately to ensure continued certification and compliance to Federal and State regulations.
• Manage vendor qualification and quality performance analytics in meeting product specifications, quality standards, and other deliverables, such as test results.
• Perform Vendor audits to ensure vendor compliance to cGMP regulations under 21 CFR Part 111.
• Manage and drive the company Corrective and Preventative Action (CAPA) system.
• Oversee management of Customer Quality Complaints. Escalate and report high incidents to the Director of Product Development and Quality to determine if further actions are required.
• Interview, hire and train new employees as the team expands.
• Regulatory Inspection, Recall, and Serious Adverse Event Team Leader.
• Other duties as assigned.

Desired Skills and Experience

• 5+ years of direct experience in the dietary supplement industry with 21 CFR 11, 21 CFR 111, and 21 CFR 117 experience
• 2+ years of management experience, preferred
• Excellent communication (written, oral, interpersonal) and grammar skills.

• Energy and enthusiasm to develop processes from the ground up, drive and track tasks, and identify opportunities for continuous improvement process.
• Vigorous attention to detail
• Utilize decision-making skills to consider the relative costs and benefits of potential actions with recommendations to management.
• Knowledge of the Dietary Supplement Health & Education Act (DSHEA) will be critical to success in this role.

• Solid understanding of regulatory requirements including a strong working knowledge of Quality Risk Management and Compliance.

As an equal opportunity employer, H&H Group believes in the benefits of a diverse and inclusive workplace and aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination and harassment.