Quality Manager

Company:
Elevate Health Sciences

JOB SUMMARY:
The Quality Manager leads and inspires a diverse team of quality professionals, playing a pivotal role in safeguarding product quality, regulatory compliance, and consumer safety. They oversee the Quality department, ensuring smooth operations, exceeding standards, and fostering a culture of continuous improvement.

SUPERVISION:

Works under the guidance and direction of the Director of Quality.

ESSENTIAL FUNCTIONS:

• Provide strategic direction and leadership to the quality team, fostering a collaborative and high-performing environment.
• Oversee the performance of the Quality team, providing coaching, mentorship, and performance evaluations.
• Provide regular updates on the performance of the quality department and key challenges and opportunities for improvement.
• Drive clear communication effective collaboration between teams.
• Develop, implement, and maintain comprehensive quality systems, procedures, and validations, ensuring compliance with relevant regulations.
• Oversee all quality control activities, including raw material testing, finished product testing, and in-process controls.
• Work closely with the Director of Quality to define strategic direction, prioritize goals, and allocate resources.
• Lead the preparation and execution of regulatory inspections, ensuring compliance with all requirements.
• Manage and track quality metrics and KPIs, identifying trends and opportunities for improvement.
• Represent the quality department in meetings with stakeholders, including regulatory agencies.
• Ensure manufacturing standards align with current Good Manufacturing Practice guidelines.
• Strong knowledge Dietary Supplement, TGA, OTC, and SQF regulations.
• Identify, assess, and mitigate potential risks while ensuring compliance with regulatory standards.
• Authorized person for TGA: an Authorized Person must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization;
• Perform other duties as assigned

Sanitation Supervisor Training a plus
Experience with NSF, Halal, and Organic a plus
Bilingual (English/Spanish) a plus
Experience with lab testing and OOS investigations a plus

QUALIFICATIONS:

• Bachelor's degree in a relevant science field (e.g., biology, chemistry, food science) or equivalent experience.
• Minimum 5 years of experience in a quality management role within the nutraceutical or pharmaceutical industry.
• Proven track record of leading and managing high-performing quality teams.
• In-depth understanding of FDA regulations and GMPs applicable to nutraceutical manufacturing.
• Strong experience with quality control and assurance principles and practices.
• Proficiency in quality management software and data analysis tools.

KNOWLEDGE, SKILLS & ABILITIES:

• Ability to work effectively in a fast-paced and demanding environment.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Excellent project management and organizational skills.

Our Benefits & Perks:

You will be part of an engaged, inclusive, global community that values family, giving back, beauty, and sustainability. We offer competitive benefits to eligible employees with comprehensive medical, vision, and dental coverage; supplemental life, voluntary short-term, and disability insurance; free access to therapists; a health savings account and 401k. You'll also be empowered to prioritize what's important to you through our vacation policy.