Quality Manager Unity Solutions - 4.0 Concord, NC Job Details Full-time $105,000 a year 12 hours ago Qualifications Vendor relationship building ISO standards Pharmaceutical regulatory compliance Pharmaceutical company experience Quality assurance experience within pharmaceutical industry Pharmaceutical manufacturing facility experience Full Job Description Responsibilities Manage, plan, organize, direct, and evaluate all activities and QA staff to ensure that Quality support is present on the production floor and assistant in resolving compliance concerns Comply with all company safety rules and workplace conduct requirements Inspect and test materials, equipment, processes and final products to verify compliance with quality standards Provide strong leadership, project and people management skills, and critical decision-making abilities Assure a safe and non-discriminatory working environment for employees Ensure compliance with manufacturing, specifications, and company policies. Ensure the departmental SOPs are current and staff are trained on relevant activities Manages the supplier quality program to ensure cGMP compliance over vendors that provide materials/services Ensure GMP compliance of quality systems/tools used at the site including a quality manual, policies, procedures, and work instruction documentation that make up the hierarchy of the Document Control system Maintains metrics program with measurables that achieve continuous improvements of processes and procedures Prepare the department for both internal and external authorities during audits ensuring facility is always audit ready Responsible for change control activities/documentation in QMS. Required to perform review of submission documents Ensure deviations and non-conformances are initiated, investigated, and closed Support approval of manufacturing documents (SOP's/WI, Forms) Manage relationship with Third Party Testing Labs, Equipment Vendors and Calibration Suppliers Demonstrate a deliberate focus on Safety, Quality, Continuous Improvement, and Customer Satisfaction Qualifications/Skills Required 5 + Years' experience in pharmaceutical, packaging, or similar regulated industry 2+ years direct/indirect supervisory experience and/or leading a team or process Working knowledge of GMPs, ISO standards and production processes Ability to work autonomously applying strong problem-solving skills Strong communication skills are needed to manage support personnel Ability to navigate through our ERP and QMS systems effectively Ability to work well with others and in a diverse workforce environment Must be eligible to work in the United States without restriction Physical Requirements Safely and effectively handle objects weighing between 15-20 pounds on a consistent basis, with the capability to lift up to 50 pounds when required Maintain good hand-eye coordination and manual dexterity Sustain physical endurance for a fast-paced work environment Operate and work near machinery safely