Senior Manager, Quality Assurance, Quality Op

POSITION SUMMARY The Senior Manager Quality Assurance Quality Operations is responsible for executing day to day GMP Quality Assurance activities supporting commercial and clinical products manufactured and tested by Rigels global network of contract manufacturers and laboratories The role provides operational Quality oversight throughout the product lifecycle including manufacturing readiness manufacturing and testing support batch disposition change management and Quality oversight of Quality Control activities National 158000 to 190000 Premium Market SFBANYCBoston Area 175000 to 210000 ESSENTIAL DUTIES AND RESPONSIBILITIES Manufacturing Readiness Review and approve GMP manufacturing analytical validation and quality documentation supporting commercial and clinical manufacturing campaign readinessPartner with Technical Operations Supply Chain Regulatory Affairs and external manufacturers to support manufacturing readiness and uninterrupted product supplyReview and approve specifications analytical methods sampling plans protocols and other Quality Control documentation supporting commercial and clinical manufacturingManufacturing Testing & Quality Oversight Provide Quality oversight of manufacturing and testing activities performed by contract manufacturers and laboratoriesLead or support investigations of deviations and OOSOOT events ensuring timely completion robust impact and root cause analysis and appropriate CAPAsProvide Quality oversight of Quality Control activities including analytical investigations and laboratory documentation as applicableProvide Quality oversight of Rigels stability program in partnership with Quality Control supporting establishment justification and extension of product shelf lifeExercise strong Quality judgment to identify and escalation potentially critical quality risksCollaborate with internal stakeholders as well as Rigel vendors and commercial partners to ensure timely resolution of quality issuesChange Management Lead Quality review and approval of Rigel and vendor initiated Change ControlsAssess manufacturing analytical packaging labeling testing quality system and supply chain changes for GMP regulatory and commercial impactCoordinate cross functional and partner impact assessments for Change ControlsEnsure timely assessment and implementation of approved changes supporting uninterrupted product supplyVerify implementation of approved changes during batch dispositionBatch Disposition & Product Release Conduct comprehensive QA review of executed batch records Certificates of Analysis Certificates of Compliance batch genealogy and other release supporting documentationPerform Quality disposition of API drug substance drug product and finished goods in accordance with Rigel proceduresPartner with Supply Chain and Technical Operations to ensure timely product disposition and availabilityQuality Systems & Compliance Serve as a subject matter expert for Rigels Dot Compliance EDMSEQMSCreate route review approve and maintain controlled GMP documents in Dot EDMSSupport inspection readiness Health Authority inspections and partner auditsConduct QA review of regulatory submissions such as annual reports INDIMPD and amendments and other regulatory documentsSupport continuous improvement initiatives that strengthen operational Quality Systems KNOWLEDGE AND SKILL REQUIREMENTS Bachelors degree in a scientific technical or related disciplineMinimum eight years of progressive GMP Quality Assurance experience within the pharmaceutical biotechnology or life sciences industryDemonstrated experience supporting commercial manufacturing in an outsourced CDMO environmentHands on experience with batch disposition batch record review deviation investigations Change Controls and CAPA managementWorking knowledge of applicable cGMP regulations and FDA EMA and ICH requirementsExperience supporting Quality Assurance for Quality Control including analytical investigations specifications methods and laboratory documentationExperience with electronic Quality Management Systems eg Dot Compliance Veeva MasterControl or equivalentStrong investigation risk assessment decision making and problem solving skillsExcellent communication collaboration organizational and project management skills COMPENSATION AND BENEFITS The anticipated salary range for this position is National 158000 to 190000 and if applicable Premium Market SFBANYCBoston Area 175000 to 210000 The actual salary offered will depend on several factors including experience qualifications geographic location internal equity and business needs This position is eligible to participate in Rigels annual bonus program and is eligible for equity incentive awards subject to the terms of the applicable plans This position is not commission based Rigel offers eligible employees a comprehensive benefits package including medical dental and vision coverage; life and disability insurance; flexible spending accounts; a 401k plan; paid time off; paid company holidays; and other benefits WORKING CONDITIONS PHYSICAL DEMANDS While performing the duties of this job the employee is required to stand walk; sit; talk and hear Specific vision abilities required by this job include close vision distance vision peripheral vision depth perception and the ability to adjust focus WORK ENVIRONMENT The noise level in the work environment is usually moderate Some travel may be required Rigel Pharmaceuticals Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by the law #J-18808-Ljbffr Rigel Pharmaceutical, Inc.