Manager Quality Validations Job Details | Nestle Operational Services Worldwide SA

Nestle International - Savannah, GA

Full-time

Savannah, GA

Merchant Wholesalers, Nondurable Goods

About the position

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. 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 Nestlé 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.

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.
• 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.

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.

Nice-to-haves

• 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.
• SAP Knowledge desirable.

Benefits

• Dynamic career paths.
• Robust development opportunities.
• Benefits that support physical, financial, and emotional wellbeing.