Quality Manager

The Quality Manager supports the regulatory needs of the company as outlined in the QAMP, including overseeing the Quality Control functions.  

• →Oversee the team responsible for Quality activities and functions. 
• →Manage an effective team. 
• →Ensure the team receives appropriate training. 
• →Maintain Quality Control/Quality Assurance/Microbiological testing activity records. 
• →Facilitate meetings. 
• →Manage process improvement projects. 
• →Manage the functions and personnel of the QC/QA/Micro department including evaluating competencies and doing performance assessments. 
• →Manage the Vendor Review Program and the Quality Control Program. 
• →Approve specifications provided by R&D, or from Validation data, for new or revised products, components, and raw materials. 
• →Manage and mentor QC/QA/Micro staff in professional development and job functions. 
• →Oversee and perform GMP inspections.  Enforce GMPs daily. 
• →Manage QC/QA/Micro staffing resources to support production and to ensure minimal downtime to lines. 
• →Evaluate staff resource needs and prioritize as appropriate. 
• →Communicate information and projects up and down the chain of command. 
• →Interact with Manufacturing management as their point of contact and foster a professional relationship. 
• →Perform recruiting and training tasks for new personnel. 
• →Resolve quality problems as exposed by the GMP checks, testing, and audits. 
• →Participate in validation programs and procedures. 
• →Evaluate and approve new testing procedures as supplied by outside customers and R&D. 
• →Represent the Quality Group in management team meetings. 
• →Manage lab documentation and retain samples. 
• →Establish and maintain effective, professional relationships internally and externally. 
• →Make recommendations on employment decisions (e.g., hiring, disciplinary action, termination). 
• →Formulate, implement, interpret, and affect policies and operating practices. 
• →Communicate effectively with others. 
• →Maintain a good attendance record. 
• →Perform work onsite. 
• →Perform other duties as assigned. 

• →Bachelor’s degree in chemistry, Biochemistry, or related field.  
• →Minimum 8 years experience in a QA/QC Manufacturing environment with at least 3 of those  
• →years in a leadership role. 
• →Management experience overseeing a QA or QC function in manufacturing 
• →Experience with the design and execution of stability programs. 
• →Practical knowledge of experimental design (DOE) and data analysis. 
• →Exceptional organizational skills in handling multiple priorities and meeting required business objectives and milestones. 
• →Ability to read, write, and speak English competently. 
• →Comprehensive experience with analytical laboratory tools and software systems supportive of the needs of the function (preferred). 
• →Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) and regulatory compliance/documentation requirements (preferred). 
• →Proactive professional with well-developed analytical & problem-solving skills, oral/written communication skills, and project management skills (preferred).  

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