Sr Manager, Manufacturing Quality & Compounding

Job Description

BASIC FUNCTION

• Provides leadership, oversight and management of Manufacturing Quality, Compounding personnel and activities within the Manufacturing plant
• Supports continuous improvement with emphasis on manufacturing quality systems and processes
• Ensures that manufacturing processes, facilities, and operations comply with FDA, cGMP, and internal quality standards and procedures
• In addition to working closely with Quality Assurance Team members, the Senior Manager works directly with and leads all personnel within company operations
• Is in charge of quality related investigations and commonly writes various quality investigation reports in which company operations are involved
• Works closely with Quality Assurance, Quality Control, Plant Scheduling and Maintenance/Engineering to maintain consistent product quality and compliance

SKILLS/KNOWLEDGE AND/OR ABILITIES

• Comprehensive understanding of cGMP regulations as applied to pharmaceutical manufacturing operations
• Responsible for overseeing the corporation's compounding operations with primary emphasis on manufacturing quality and effectively maximizing productivity from facilities, equipment, and human resources and complying with all relevant regulations
• Responsible for overseeing that Compounding personnel are properly trained and carefully execute manufacturing processes (SOP’s, Batch Records) GMPs, equipment, systems, and safety
• Responsible for making recommendations for new equipment and/or the modification of existing equipment and/or systems as is necessary or appropriate
• Responsible for cooperating with all Operations Management to assure that all resources and equipment in the Compounding area are properly maintained and repaired to assure validity, efficiency and safety of manufacturing processes
• Facilitate, promote, and direct timely changes in manufacturing as mandated by Management
• Knowledge of FDA, ICH, and USP regulatory requirements
• Strong investigation and report writing skills with ability to review and assess manufacturing deviations, change controls, and CAPA effectiveness
• Demonstrated ability to manage quality assurance compliance for manufacturing areas, including batch record review, line clearance, and in-process inspections
• Experience in supporting regulatory inspections and internal audits
• Proven skill in training and coaching quality assurance compliance and best cGMP practice with manufacturing personnel
• Excellent problem-solving and decision-making skills
• Ability to maintain cooperative and productive working relationships with cross-functional teams
• Demonstrated ability to manage multiple priorities and meet deadlines in a dynamic environment
• Strong written and verbal communication skills

GENERAL RESPONSIBILITIES

• Responsible for overseeing the corporation's compounding operations with primary emphasis on manufacturing quality and effectively maximize productivity from facilities, equipment, and human resources and to comply with all relevant regulations
• Responsible for overseeing that Compounding personnel are properly trained and carefully execute manufacturing processes (SOP’s, Batch Records) GMPs, equipment, systems, and safety
• Maintain current knowledge of applicable regulatory and quality requirements.
• Communicate effectively with management and peers regarding quality and compliance issues.
• Support the continuous improvement with emphasis on manufacturing quality systems and processes

SPECIFIC DUTIES AND TASKS

• Provide manufacturing quality and compounding operations oversight for all related manufacturing operations, ensuring adherence to cGMPs and internal procedures
• Review and approve manufacturing batch records, line clearance documentation, and associated procedures and forms
• Oversee and (commonly) author investigation of manufacturing deviations, non-conformances, and out-of-specification (OOS) results
• Lead or support root cause analyses and ensure timely and effective implementation of corrective and preventive actions (CAPAs)
• Collaborate with Manufacturing, Quality Control, and Engineering/Maintenance to resolve quality-related issues in production
• Participate in validation activities related to manufacturing processes, cleaning, and equipment
• Review and approve change controls impacting manufacturing processes, facilities, and equipment
• Ensure readiness for FDA and other regulatory inspections through routine audits, training, and documentation reviews
• Monitor quality metrics related to manufacturing performance and compliance trends.
• Support continuous improvement initiatives with emphasis on enhancing manufacturing quality, process capability, and GMP compliance
• Train and mentor QA personnel and manufacturing operators on quality-related topics
• Perform other duties as assigned to support the Quality Assurance and Manufacturing departments

SPECIAL SPECIFIC DUTIES

Review and approval for:

• Manufacturing batch production records
• In-process control documentation
• Manufacturing deviations and CAPA closures
• Change control records related to manufacturing

REQUIREMENTS

EDUCATION

Preferred: Baccalaureate Degree in Engineering, Business or Physical Sciences

LICENSING/REGISTRATION/CERTIFICATION

Preferred: Quality Assurance or Quality Management Certification (e.g. ASQ, CQA, CQE)

EXPERIENCE

• Required: 6–8 years of progressive experience in pharmaceutical compounding, manufacturing including Quality Assurance or Quality Systems experience
• Preferred: 3–5 years of leadership or supervisory experience in a GMP-regulated manufacturing quality environment. Solid-dose manufacturing and Quality Assurance experience preferred.