Director of Quality

ESSENTIAL DUTIES AND RESPONSIBILITIES

Core duties and responsibilities include the following. Other duties may be assigned.

• LEAD QUALITY OPERATIONS
• Lead Quality operations to support overall company goals and strategic directives
• Develop and oversee the company’s Quality Management System that supports manufacturing and distribution activities.
• Ensure the existence of a comprehensive standard operating procedures (SOP) documentation system that follows FDA GMP regulations.
• Ensure the development, implementation and control of budgets, plans and performance standards.
• Monitor performance metrics to gauge progress towards business unit goals and objectives and take necessary corrective actions.
• Ensure that all quality system policies and procedures are followed and to make sure all products delivered to the customer meet identified requirements.
• Ensure that Continuous Operations Improvement (COI)/Lean concepts and techniques are utilized throughout the Quality operations.
• Develop ongoing strategies from reducing cost, and time, while maximizing quality.
• Acts as the “face of the company” with internal and external stakeholders, including regulatory agencies and board of directors.
• Confers with team about regulatory compliance for new products designed and manufactured products on market to rectify problems.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
• Prepares and participates in all regulatory audits; serving in a lead role for the organization.
• LEADERSHIP AND PROCESS IMPROVEMENT
• Create and/or foster a leadership environment that is conducive to teamwork and otherwise demonstrates genuine concern for the personal and professional development of all employees.
• Ensure the development and deployment of a safe and healthy work environment including proper training in safety practices.
• Oversees staffing, scheduling, and training for quality.
• Continuously recruits, develops, and coaches top talent to deliver outstanding performance.

Directly and indirectly supervises Quality & Regulatory team. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints.

• Analytical - Synthesizes complex or diverse information;
  Collects and researches data;
  Uses intuition and experience to complement data;
  Designs work flows and procedures.
• Problem Solving - Identifies and resolves problems in a timely manner;
  Gathers and analyzes information skillfully;
  Develops alternative solutions.
• Project Management - Develops and coordinates project plans;
  Communicates changes and progress;
  Completes projects on time and budget;
  Manages project team activities.
• Oral Communication - Speaks clearly and persuasively in positive or negative situations;
  Demonstrates presentation skills;
  Participates/Leads meetings.
• Written Communication - Writes clearly and informatively;
  Edits work for spelling and grammar;
  Presents numerical data effectively;
  Able to read and interpret written information.
• Managing People – Plans and facilitates process improvement;
  Takes responsibility for subordinates' activities;
  Makes self available to staff;
  Provides regular performance feedback;
  Develops subordinates' skills;
  Fosters quality focus in others;
  Improves processes, products and services;
  Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality;
  Demonstrates accuracy and thoroughness.
• Business Acumen - Understands business implications of decisions;
  Displays orientation to profitability;
  Demonstrates knowledge of market and competition;
  Aligns work with strategic goals.
• Ethics - Treats people with respect;
  Keeps commitments;
  Inspires the trust of others;
  Works with integrity and ethically;
  Upholds organizational values.
• Quality - Demonstrates accuracy and thoroughness;
  Looks for ways to improve and promote quality;
  Applies feedback to make improvements.
• Safety and Security - Follows & ensures staff are following safety and security procedures.

The requirements listed…