Director of Quality Operations

Job Description Position SummaryThe 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 ResponsibilitiesEnsure 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 neededOther duties as assignedRegulatory ResponsibilitiesKeep abreast of changes to quality regulations and guidelines, advise the management team of any business implications of these changesMaintain a detailed and comprehensive understanding of FDA, EU and other regulatory agency requirementsConduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211 and other regulatory agency requirementsSupervisory ResponsibilitiesLead and direct work and provide feedback to a team of QA SpecialistsLead, manage and ensure proper training to any relevant change management programs throughout the companyExperienceEight to ten (8-10) years of progressively responsible related quality assurance experienceEducationBachelor's DegreeKnowledge, Skills & AbilitiesSubject matter expertise in FDA, EU, and other regulatory agency requirementsComprehensive knowledge of QA concepts and principlesKnowledge of cGMP principlesKnowledge of RCA toolsAbility to work as part of a teamManagement skillsAbility to manage multiple client relationships and priorities effectivelyGood oral and written communicationProblem/situation analysisAbility to build collaborative relationshipsUses good judgementPerform complex work instructions and problem solving following established processesExperience with Microsoft Office and general computer proficiencyQuality mindset and a willingness to develop yourself and othersPhysical RequirementsAbility to remain stationary for long periods of timeAbility to move between locationsMay occasionally lift up to 10 lbs.