Quality Manager

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