Quality Affairs Senior Director - Sterile Injectables
American Regent, Inc.
American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management system for sterile injectable manufacturing. You will oversee laboratory operations, regulatory inspections, supplier quality, and external CMOs, ensuring cGMP compliance and robust continual improvement. You will drive KPI-based quality programs, manage deviation/ CAPA processes, and collaborate with Production, Regulatory Affairs, Engineering, R&D and QA #J-18808-Ljbffr American Regent, Inc.
- Nature and Scope Reporting to the Senior Director of Quality is a multi-disciplinary management role... ...production for the manufacture of sterile injectables. This position is responsible for... ...Partner with Production, Regulatory Affairs, Engineering, R&D and QA Compliance...QualitySeniorWeekend work
$275k - $285k
...pharmaceutical manufacturer in Shirley, NY. We are seeking a Sr. Director Quality Affairs to provide strategic leadership across site-wide... ...Master's degree in Life Sciences. Experience in sterile injectables manufacturing and packaging operations. skills: Good...QualitySeniorPermanent employmentTemporary workWork experience placement$77.2k
...direction, and oversight of initiatives in areas including, but not limited to digital technologies, operational efficiency, program quality, resource allocation, data analysis, coordinated dissemination, reporting, and process improvement. - Provide creative and...QualitySeniorFull timeWork at office- Ports North seeks an interim VP of Quality to provide senior leadership across sterile injectable pharmaceutical manufacturing during a transformation phase. The role entails stabilizing quality programs, advancing regulatory remediation, and guiding modernization of aseptic...QualityRemote jobInterim role
- Zebra Technologies seeks a Connected Frontline Senior Director of Technical Program Management to lead portfolio execution across hardware... ...excellence, and drives measurable value through speed to market, quality, and customer outcomes, while advancing AI-enabled delivery...QualitySenior
$108.96k - $163.44k
...Organizes and presents business, technical and program status to Senior Leadership using digital media, dashboards and JIRA project... ...Motivate a project team to ensure solutions are reliable and of quality, in a highly collaborative fashion Personally anticipates and...QualitySeniorWork experience placementSummer workWork at officeFlexible hours$156.96k - $235.44k
...cross-functional cloud platform. Join Zebra Technologies as the Senior Manager, Technical Program Management, and lead a... ...using Zebra’s Lifecycle Management process, and providing a high-quality customer-facing solution that drives value and upsells on the basis...QualitySeniorSummer workLocal areaRemote workFlexible hours3 days per week$202.56k - $303.84k
...day at Zebra. What We’re Looking For The Connected Frontline Senior Director of Technical Program Management is responsible for portfolio... ...initiatives deliver measurable value through improved speed to market, quality, operational efficiency, risk reduction, and customer...QualitySeniorContract workSummer workWork at officeLocal areaFlexible hours$105k - $115k
The Sr. Quality Management Systems Specialist provides coordination and reporting that includes... ...possible outstanding actions for both Sterile and Non-Sterile Quality Operations... ...matter expert for electronic QMS. Provides Senior Quality Management leadership with timely...QualitySeniorFlexible hours- ...compliance with procedures and regulations across the APA. The role includes direct management of Sterility Assurance and video monitoring staff with full signatory authority for quality matters. Responsibilities include oversight of media fills, environmental monitoring, risk...Quality
$156k - $185k
Nature and ScopeThe Senior Manager of manufacturing will be responsible for managing and... ...Compounding, Equipment/ Component Preparation, Sterile Filling, Inspection and Packaging.Ensure... ...continuous development of people & team, quality expectations, compliance, safety,...QualitySeniorFull timeTemporary workImmediate start- American Regent, Inc. is seeking a QA Senior Specialist - CAPA to ensure corrective and preventive actions and their effectiveness checks... ...and supports SNCR processes, regulatory audits, and Quality Council activities. The successful candidate will drive CAPA aging...QualitySenior
- ...Directorate Chief Operating Officer (DCOO) Reporting to the Associate Laboratory Director (ALD), the DCOO serves as the senior operational leader for the Directorate, providing strategic leadership... ..., Integrated Safety Management, Quality Assurance, and other...QualityFor contractors
$112.65k - $150k
The Radiological Control Division provides radiological expertise through field-deployed technical personnel. It maintains an accredited personnel monitoring service, an instrumentation and calibration facility, and expertise in radiological engineering and nuclear materials...SeniorFor contractorsWork experience placementWork at office$120k - $130k
...HR Director Status: Full-time | Exempt Reports To: VP of Operations Location: East Moriches, NY Salary Range: $120,000 - $130,000 Commensurate... ...to our work, coupled with our emphasis on exceptional quality and service has earned us the reputation as one of Long Island’...QualityFull timeContract workApprenticeshipWork at officeLocal area$80k - $95k
Nature and Scope The QA Senior Specialist - CAPA is responsible for ensuring that Corrective... ..., regulatory audit activities, and the Quality Council process. This is a cross-... ...manufacture of safe, pure, and effective sterile pharmaceuticals are investigated, written...QualitySenior- American Regent, Inc. is seeking a QC Chemist IV to perform analytical testing on raw materials, in-process, and finished products in our Quality Control Laboratories in Shirley, NY. You will operate instruments (HPLC, GC, AA, UV-VIS, ICP), maintain GMP documentation, and...QualitySenior
- ...properties in the New York area. The role requires hands-on maintenance expertise, team leadership, and a strong commitment to safety and quality service. You will supervise technicians, coordinate preventive maintenance, manage urgent repairs, and support the Maintenance...QualitySenior
- Operations in the Town of Brookhaven is seeking a Sr. Quality Management Systems Specialist who will coordinate and report on various Quality Management processes. The role involves data collection, analysis, and regulatory compliance, contributing to quality assurance...QualitySenior
$85k - $123k
...Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.Must understand and apply cGMP requirements applicable to quality control laboratory.Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument...QualitySeniorLocal areaFlexible hours$23.61 - $25 per hour
...This position is responsible for providing Quality oversight in manufacturing areas... ...manuals.* Ability to meet and maintain sterile gowning requirements.* Ability to work overtime... ...of branded and generic specialty injectables.American Regent, Inc., a Daiichi Sankyo...QualityHourly pay- Division Director - Technical Division The Electron‑Ion Collider (EIC) is one of the most exciting... ..., and project commitments. Compliance, Quality, & Safety Maintain a safe work... ...enterprise, including at least eight (8) years in senior or executive leadership roles....QualityFor contractors
- ...organization to grow your career Position Summary The Senior HVAC Technician is responsible for performing expert-level... ...technicians. The Senior Technician ensures all work meets safety, quality, and compliance standards while providing exceptional customer...QualitySeniorFull timeApprenticeshipLocal areaRelocation package
- **Job Opportunity: Director of Admissions** **Position Overview:** Seeking a dynamic and results-driven **Director of... ...patient-centered approach with a dedication to providing high-quality care. **Why Medford?** - Competitive salary and benefits package...QualityLocal area
- ...as free cafeteria service and an on-site gym/wellness center! DIRECTOR OF ADMISSIONS ACCESS SERVICES - Full Time. On Site in Calverton... ...for attainment of all performance measures including quality, service level, and customer satisfaction Leverage data and...QualityFull timeLocal area
- ...life cycle management of GxP Computerized systems through QMS policies, documentation and change control. Prepare KPIs in support of quality reporting to management. Assist in other QA tasks as assigned, including Veeva Vault workflows, reporting and configurations....QualitySeniorPermanent employmentContract workLocal area
$145k - $160k
...technical leadership and hands on support for sterile manufacturing operations, including Blow... ..., Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development/... ...environment. High attention to documentation quality, compliance, audit readiness, and patient...QualityLocal areaFlexible hours- ...and controls work, ensuring construction activities comply with engineering drawings, project specifications, applicable codes, and quality standards. The ideal candidate holds a Bachelor's degree in Electrical Engineering with at least 10 years of electrical field #J-1...QualitySenior
- Zebra Technologies in Holtsville, NY is seeking a Senior Director of Technical Program Management to drive the launch of scanning, printing, and supplies across business units. You will lead strategic program management and align with senior leadership to shape roadmaps...Senior
$117.9k - $137k
...direct managerial responsibility for the Sterility Assurance function and video monitoring... ...signatory authority and accountability for quality/compliance matters within the scope of... ...of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo...Quality
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Affairs Senior Director - Sterile Injectables. Be the first to apply!
- quality Shirley, NY
- quality manufacturing Shirley, NY
- quality inspection Shirley, NY
- quality equipment Shirley, NY
- senior manager diversity & inclusion Shirley, NY
- senior application security Shirley, NY
- director of quality improvement
- quality manager medical devices
- senior manager quality engineering
- director of clinical quality


