Nestle
Manager Quality Validations
Nestle, Savannah, Georgia, United States, 31441
At Nestlé 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 Nestlé 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 Operations Project Sunrise, the Manager Project 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.
Key Responsibilities:
• 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.
• Align with factory and project teams project design/planning including, but not limited to project charter, URS development, change management and project handoff to factory.
• Coordinate and align with factory quality team on project deliverables including but not limited to SOPs, QMS, HACCP and records development and modifications.
• Coordinate and manage coverage individually or with a small team of all required standard implementation of equipment and processes into the factory including, but not limited to install, commissioning, validation and system/documentation update activities.
• Facilitates and presents data and information pertaining to quality performance to upper management.
• Develops cross functional and multinational relationships to support interaction with various internal customers.
• 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.
• 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.
Experience and Education Requirements:
• Bachelor's degree or Equivalent Experience in lieu of degree
• Experience in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field
• 5+years of 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
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
Requisition ID: 325070
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 Nestlé. 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. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.
The Nestlé 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 accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy
At Nestlé 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 Operations Project Sunrise, the Manager Project 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.
Key Responsibilities:
• 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.
• Align with factory and project teams project design/planning including, but not limited to project charter, URS development, change management and project handoff to factory.
• Coordinate and align with factory quality team on project deliverables including but not limited to SOPs, QMS, HACCP and records development and modifications.
• Coordinate and manage coverage individually or with a small team of all required standard implementation of equipment and processes into the factory including, but not limited to install, commissioning, validation and system/documentation update activities.
• Facilitates and presents data and information pertaining to quality performance to upper management.
• Develops cross functional and multinational relationships to support interaction with various internal customers.
• 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.
• 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.
Experience and Education Requirements:
• Bachelor's degree or Equivalent Experience in lieu of degree
• Experience in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field
• 5+years of 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
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
Requisition ID: 325070
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 Nestlé. 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. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.
The Nestlé 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 accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.
This position is not eligible for Visa Sponsorship.
Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy