Quality Unit Manager

LocationBrookfield, Connecticut
Reports ToVP Quality and Regulatory
Position Overview

Site Quality Unit Manager is responsible for overall compliance of the site quality management system with the applicable GMP requirements. Site QU Manager has direct responsibility for performance and compliance of the site Quality Control, Quality Assurance and Document Control Departments.  Site QU Manager is responsible for providing leadership, demonstrating commitment to a successful quality system, and collaborating with other site departments as well as collaborating with QU Managers for other company sites to ensure its implementation and maintenance throughout the organization.

Duties & Responsibilities
  • Provide overall oversight of the site’s GMP compliance
  • Provide leadership and communication on all quality related matters with both internal and external groups and customers
  • Support company and department goals, projects, and performance
  • Ensure that company quality standards and applicable GMP requirements are being maintained and met
  • Ensure compliance with Good Documentation Practices and Data Integrity requirements throughout the organization
  • 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, and promote a professional working environment
  • Understand operational and manufacturing processes and corporate strategic objectives and ensure that they meet applicable GMP and ISO requirements and support quality and business management systems requirements
  • Ensure the entire site Quality Unit functions in accordance with applicable GMP
  • Ensure that Quality Control department is assessing the suitability of incoming raw materials, containers and closures, in-process materials, and the finished products; evaluating the performance of the manufacturing process to ensure adherence to proper specifications and limits; and is determining the acceptability of each batch for release
  • Ensure that Quality Assurance department reviews and approves all procedures related to quality, production, and maintenance, reviews all associated production and quality records, and releases final product for distribution
  • Ensure that Document Control department establishes proper levels of control over issuance and accountability of the batch production records and labels
  • Maintain a working knowledge of QC laboratory quality systems
  • Develop and implement comprehensive training programs for the quality control, quality assurance and document control departments. Ensure that training program includes evaluation of training needs, provision of training to satisfy these needs, evaluation of effectiveness of training, documentation of training and/or re-training.  Verify that skills gained from training are implemented in day-to-day performance
  • Provide technical and analytical support to other department for the new product introduction and ensure test method development and QC training for new product
  • Collaborate with other departments to ensure qualification, verification, validation, and stability activities are executed in accordance with established procedures
  • Ensure test methods are validated, and equipment is calibrated and well maintained. Make decisions on acceptability of test methods in use in the laboratory
  • Ensure that all quality documentation and SOPs are maintained, updated, reviewed, and approved to reflect current processes
  • Investigate and respond to all customer complaints related to the product quality
  • Develop and implement appropriate corrective and preventive actions to deliver continuous improvement
  • Ensure regular interaction with quality unit staff, peers, and management, as well as maintaining a cooperative and supportive relationship with the Plant General Manager
  • Continue development of the Quality Unit, including creating efficiencies and improving timelines
  • Provide input in performance review and objective/goal generation to QC supervisor, Quality Assurance and Document Control staff
  • Implement, maintain, and verify quality assurance functions associated with inbound and outbound product.
  • Ensure QA staff is properly trained to support Production on the Plant Floor
  • Provide guidance and direction to all operational departments to ensure good quality practices
  • Ensure validation and commissioning of all new equipment is properly executed and documented
  • Prepare for and host customer audits
  • Participate in site audits by ISO certifier, GMP certifier, organic certifier, Department of Consumer Protection, other local and federal agencies as it relates to the quality unit functions
  • Maintain professional and technical knowledge by attending educational workshops and webinars
  • Adheres to, and ensure staff adheres to all facility Environmental, Health, & Safety policies.
Skills & Qualifications
  • BS degree in Chemistry or related science
  • Minimum of 5 years in a Quality Assurance Management Role
  • Minimum of five years of ISO and GMP experience
  • Strong organizational and communication skills a must
  • Demonstrated ability to foster a team oriented working environment
  • Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
  • Ability to foster collaborative, cross department relationships to meet common objectives.