• Job Description

  Req#: 503753

  Position Summary	The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignment with customer & regulatory requirements and company objectives. The role requires a blend of technical expertise, analytical thinking, and leadership skills to address challenges, optimize processes, foster a culture of continuous improvement across the organization and enhance client relationships.
  Duties and Responsibilities	Ensure compliance with cGMP, FDA, and other applicable regulatory requirements for sterile drug manufacturing. Lead the team in quality oversight of manufacturing processes, ensuring adherence to SOPs and quality standards. Drive initiatives to strengthen aseptic technique, contamination control strategies, and data integrity practices. Support the development and maintenance of a robust risk management program, ensuring all critical issues are addressed with sustainable solutions. Serve as the quality operations representative during internal and external meetings with clients and other entities. Respond to client inquiries, quality concerns, and requests in a timely and professional manner. Oversee the resolution of client-related deviations, investigations, and CAPAs, ensuring timely closure. Provide root cause analysis and implement preventive measures for recurring client concerns. Lead cross-functional teams to ensure effective resolution of quality issues impacting clients. Facilitate effective communication between clients and internal stakeholders to ensure alignment on quality objectives. Travel as needed Other duties as assigned
  Regulatory Responsibilities	Keep abreast of changes to qua l ity regulations and guidelines, advise the management team of any bus i ness i mplications of these changes Maintain a deta il ed and comprehensive understanding of FDA, EU and other regulatory agency requ i rements Conduct all work i n compliance with FDA, 21 CFR 820, 21 CFR 210 and 211 and other regulatory agency requirements
  Supervisory Responsibilities	Lead and direct work and provide feedback to a team of QA Specialists Lead, manage and ensure proper training to any relevant change management programs throughout the company
  Experience	Eight to ten (8-10) years of progressively responsible related quality assurance experience
  Education	Bachelor's Degree
  Knowledge, Skills & Abilities	Subject matter expertise in FDA, EU, and other regulatory agency requirements Comprehensive knowledge of QA concepts and principles Knowledge of cGMP principles Knowledge of RCA tools Ability to work as part of a team Management skills Ability to manage multiple client relationships and priorities effectively Good oral and written communication Problem/situation analysis Ability to build collaborative relationships Uses good judgement Perform complex work instructions and problem solving following established processes Experience with Microsoft Office and general computer proficiency Quality mindset and a willingness to develop yourself and others
  Physical Requirements	Ability to remain stationary for long periods of time Ability to move between locations May occasionally lift up to 10 lbs.

• About the company

  Industry leading sterile manufacturing CMO. Providing sterile fills for vials, cartridge, syringes, and lyophilized product, entirely within isolators.

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