Quality Manager

Job Description

This position requires strong leadership skills to motivate and guide production teams. Chemistry techniques and strategic thinking are essential to enhance production processes, reduce costs, and meet quality standards. The Quality Manager is a key figure in maintaining pharmaceutical manufacturing operations at the highest standards of quality and efficiency.

Responsibilities

• Manage production schedules according to staffing guidelines and ensure production goals are met.
• Monitor and track production metrics including Variance, Yields, Days Lost, and Product/Labor ratio.
• Review and modify controlled documents including SOPs, variances, batch production, control records, OOT/OOS, QC alerts and notices, corrective action requests, and investigative reports as needed.
• Ensure batch documentation is accurate and completed in a timely manner.
• Ensure personnel perform competently and in compliance with company policies, SOPs, and cGMPs.
• Ensure adherence to safety protocols.
• Conduct performance evaluations and disciplinary actions as needed.
• Maintain positive employee relationships across all business units.
• Participate in internal and external audits by government agencies, customers, and internal Quality Assurance personnel.
• Work with internal and external entities to complete repairs and improvements on plant facilities, systems, machines, and equipment.
• Coordinate with outside contractors and follow up on contracts as needed.
• May be required to carry an electronic device for 24-hour call in.

Essential Skills

• Proficiency in efficient manufacturing techniques, process improvement, and production scheduling.
• Strong skills in material and supply chain management.
• Problem-solving skills and an analytical thought process.
• Business writing skills including the ability to write investigative reports and summaries.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and government regulations.
• Attention to detail and ability to coordinate various activities simultaneously.
• Ability to manage multiple priorities and work with minimal supervision.
• Ability to communicate courteously and professionally with co-workers, management team members, and other individuals.

Additional Skills & Qualifications

• 5+ years of work experience in the Science/Pharma/Manufacturing/QA field.
• At least 3-5 years of management experience.
• Proven experience in quality assurance, quality control, and quality management.

Work Environment

The role operates in a dynamic pharmaceutical manufacturing environment that requires adherence to safety protocols and standards. The position may require carrying an electronic device for 24-hour call in. The work involves collaboration with internal and external entities, including contractors, to ensure efficient operations and facility improvements.