Senior QA Compliance Manager

LocationBrookfield, Connecticut
LocationShelbyville, Kentucky
DepartmentQuality Assurance
Reports ToVice President of Quality
Position Overview

Senior Quality Assurance Compliance Manager is responsible for establishing and maintaining of the quality management system and business management system in compliance with ISO 9001, EXCiPACT and applicable GMP requirements.  Senior Quality Assurance Compliance Manager is responsible for providing leadership, demonstrating commitment to a successful quality and business management systems, and collaborating with other departments to ensure its implementation and maintenance throughout the organization.

Duties & Responsibilities
  • Maintain quality and business management system by engaging all business leaders to meet ISO, EXCiPACT, GMP, Organic, and other certifying body requirements while facilitating efficient business operations
  • Support the performance and adequacy of the quality program to remain in compliance with the requirements of all applicable governing agencies
  • Support the corporate culture.  Communicate and instil the corporate values to staff
  • Understand operational and manufacturing processes and corporate strategic objectives and ensure that they meet ISO, EXCiPACT and applicable GMP requirements and support quality and business management systems requirements
  • Maintain CAPA, Quality Risk Assessment, Deviations, Management of Change, Change Controls and Continuous Process Improvements
  • Oversee Root Cause Analysis investigations and results
  • Manage the approval and qualification process for new vendors and suppliers
  • Coordinate and direct Internal Audits and internal auditor program
  • Maintain activities associated with ISO certification, EXCiPACT (GMP) certification, Organic certification, and non-GMO verification.  Prepare for and host audits associated with these certifications
  • Facilitate Semi-Annual Top Management Meeting and maintain minutes of the meeting
  • Support Customer required Quality Agreements by reviewing and proposing applicable changes
  • Participate on the Product Selection Committee (PSC), New Product Introduction Committee (NPI), and New Products Project Status Meetings
  • Ensure Corporate Metrics are compiled accurately and distributed in a timely manner
  • Ensure quality-critical documents are maintained and reviewed in accordance with the internal policies and compliance with applicable requirements.  Ensure compliance with the Triennial Documentation Review process and Visual Aid Audits
  • Maintain Quality Assurance Compliance staff performance excellence by coaching, counselling and empowering employees
  • Continue development of the Quality Assurance Compliance department, including creating efficiencies, improving timelines and develop comprehensive training programs
  • Provide performance review and objective/goal generation to the Quality Assurance Compliance department staff
  • Support all business leaders and employees in maintaining compliance with quality compliance protocols and certifications
  • Provide guidance and direction to all operational departments to ensure compliance with good quality practices
  • Maintains professional and technical knowledge by attending educational workshops and webinars.
Skills & Qualifications
  • Bachelor’s degree and/or equivalent years of experience managing a quality system
  • Minimum five years of Quality experience, preferably chemical manufacturing
  • Must have strong communication and computer/systems skills
  • Experience working in a GMP and/or ISO facility preferred
  • TTB and/or other regulatory compliance experience preferred.
Qualities
  • Possesses Company values of honesty, integrity, respect, commitment and openness to change while modelling the Company Core Principles in all activities
  • Ability to foster collaborative, cross department relationships to meet common objectives.