Quality Manager

POSITION OVERVIEW:

Under the direction of the Factory Manager and 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 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. Quality Manager is also responsible for managing direct reports within the Quality Assurance group.

• Develop 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.
• Leads, 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 testing, 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 the Material Review Board (MRB) for non-conforming materials, determination and documentation of dispositions of said material.
• Develop 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 around mock recall, retrieval, and recall.
• Supports the Facility Manager in daily activities and quality system.
• 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, Nestlé 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.
• Understand 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 Food Safety and HACCP Programs for the facility.
• Support goal setting, administer performance appraisals and conduct interviews for new candidates.
• Responsible for supporting HPS (High Performance Systems) principles and beliefs.
• Other duties may be assigned as required.

• 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’ experience in the food, dietary supplement, medical device or pharmaceutical industry is preferred.
• Experience leading teams.
• Technical experience with manufacturing processes associated with powders is a positive.
• Knowledge of FDA regulations for the cGMP of Dietary Supplements and Foods.
• Experience with Food Safety plans/HACCP, GFSI.

• Excellent communication and interpersonal skills, being…