Facility Quality Manager

    • Nestle USA
  • Holbrook, NY
  • Posted 32 days ago | Updated 2 hours ago

Overview

On Site
USD 100,000.00 - 110,000.00 per year
Full Time

Skills

Standard operating procedure
Root cause analysis
Quality management
Microsoft Word
Manufacturing
Quality assurance
FDA
Corrective and preventive action
Change control
Problem solving
Decision-making
Production control
Document review
Test equipment
IT service management
KPI
Continuous improvement
Chemical engineering
Medical devices
Pharmaceutical industry
Team leadership
Organizational skills
Positive attitude
Science
Collaboration
Finance
IMPACT
Regulatory Compliance
SOP
Good manufacturing practice
Management
Coaching
Counseling
Auditing
Data
Leadership
Documentation
MRB
Communication
Planning
Training
Statistical process control
Operations
Metrics
Hazard analysis and critical control points
Pharmaceutics
Chemistry
GMP
Statistics
ISO 9000
Microsoft Excel
SAP
Chemicals

Job Details

At Nestl Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life , Nature's Bounty , Vital Proteins , Orgain , Nuun , BOOST , Carnation Breakfast Essentials , Peptamen , Compleat Organic Blends , and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

At Nestl Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

POSITION SUMMARY

Under the direction of the Director Quality, the Manager Facility Quality is responsible for ensuring the compliance of the quality systems, manufacturing processes and associated records for adherence to Nestle Health Science. Standard Operating Procedures (SOP's) and Good Manufacturing Practices (cGMP's) that are in effect within their manufacturing site, assuring the quality of products produced.

Quality Manager is also responsible for managing direct reports within the Quality Assurance group.

Key Responsibilities:

List the main results which the job must deliver in order to achieve its purpose.
  • Develops staff through feedback, coaching, counseling and support.
  • Ensures both new and existing associates are trained on cGMPs as it relates to 21 CFR part 111.
  • Maintains compliance with FDA Regulations and other industry accepted standards.
  • Supports and participates in audit preparations and inspections by certifying agencies and regulatory bodies, i.e. USP & FDA. Participate in developing action plans and executing corrective actions in a timely manner.
  • Leads, anticipates, assesses and manages current and future compliance in the facility.
  • Ensures accurate and timely completion of all tasks relating to Batch records and maintenance of cGMP and SOP records.
  • Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA). Evaluate
  • data using statistical tools. Lead or actively support Product Change Control.
  • Works collaboratively with cross-functional teams to implement necessary production changes, system updates, and documentation revisions in a timely and productive manner.
  • Facilitates and properly manages the Quality Management Systems including but not limited to; Deviations, Non-Conformances, CAPAs, Change controls.
  • Facilitates and presents data and information pertaining to quality performance to upper management.
  • Facilitates Material Review Board (MRB) for non-conforming materials, determination and documentation of dispositions of said material.
  • Develops cross functional and multinational relationships to support interaction with various internal customers.
  • Supports, leads, administers all mock recall activities for the site; is the expert in the area of mock recall, retrieval, and recall.
  • Supports the Quality Manager in daily activities and quality system. In addition act as the site lead in the absence of the Quality Manager.
  • Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, Nestle Health Science's core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training.
  • Understands SPC and how to leverage data to drive improvements into processes.
  • Partners with Operations team and Technical Services group to execute and facilitate site initiatives in pursuit of business objectives and targets.
  • Acts as role model of the business vision and mission and have a strong understanding of what it takes to achieve company goals, KPI's and metrics.
  • Supports continuous improvement activities when Quality KPIs are not met.
  • Supports management of the HACCP Program for the facility.
  • Support goal setting, administers performance appraisals and conducts interviews for new candidates.
  • Responsible of supporting HPS (High Performance Systems) principles and beliefs.
  • Other duties may be assigned as required.

Key Relationships (Internal)
  • What individuals/groups does the incumbent need to work with, communicate with and influence to ensure delivery of products and/or services delivered by this job?

Key relationships (External)
  • What individuals/groups does the incumbent need to work with, communicate with and influence to ensure delivery of products and/or services delivered by this job?

Experience and Education Requirements
  • Bachelor's degree or Equiv Experience in lieu of degree
  • Experience in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field
  • 5+ years experience in the food, dietary supplement, medical device or pharmaceutical industry
  • Experience leading teams
  • Knowledge of FDA regulations for the cGMP of Dietary Supplements and Foods
  • Experience with Food Safety plans/HACCP, GFSI

Preferred Skills
  • Excellent communication and interpersonal skills, being very detailed oriented
  • Ability to lead, train, motivate, and work within a team
  • Good planning and organizational skills
  • Proven ability to manage of Quality Systems.
  • Knowledge of regulatory and GMP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
  • Knowledge of Quality Management Systems e.g. CAPA, Product defense, Pest Control.
  • Knowledge of auditing techniques and quality toolkit - problem solving, basic statistics, investigations, corrective/ preventive actions
  • SQF practitioner / FSSC/ BRC/ ISO experience preferred
  • Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
  • SAP Knowledge desirable
  • Must exhibit exemplary behaviors in line with NHSc's principles and values

Expected high performance behaviors:
  • Exhibit positive attitude regarding work and responsibilities
  • Ability to work collaboratively within teams
  • Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
  • Continuously look for ways to do things faster and better, while maintaining high quality standards

Additional Notes

Physical Demands:
  • Work environment may be exposed to powders, chemicals and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish)

Travel:

Approximately 10% travel may be required

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The approximate pay range for this position is $100,000.00 to $110,000.00. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location.

Nestl offers performance-based incentives and acompetitive total rewards package, which includes a401k with company match, healthcare coverage and a broad range ofother benefits. Incentives and/or benefit packages may varydepending on the position. Learn more at

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestl. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestl seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestl home.

The Nestl Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at or please dial 711 and provide this number to the operator: 1-.

This position is not eligible for Visa Sponsorship.

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