Quality Assurance Director

Career Opportunities with Rigel PharmaceuticalA great place to work.Join Our TeamShare with friends or Subscribe!Are you ready for new challenges and new opportunities?Current job opportunities are posted here as they become available.Subscribe to our RSS feeds to receive instant updates as new positions become available.This position reports to the Senior Director, Quality Assurance and will independently manage the Quality aspects of commercial and clinical drug manufacturing, validation, and operations at the contract manufacturers. This position is responsible for the management, operation, and upkeep of the Quality Assurance activities and support Inspection readiness activities for GxP (GMP, GLP, & GCP) programs. This position is also responsible for assistance in vendor oversight and day to-day QA operations and fosters a culture of continuous improvement in all aspects of GxP Quality, including the development and administration of policies and practices that address quality issues throughout the organization and enhancement of electronic systems and new technologies.Salary Range:National $185,000 - $215,000ESSENTIAL DUTIES AND RESPONSIBILITIES:Perform quality oversight of cGMP activities which include independently setting up and/or optimizing processes for, drug substance and drug product manufacturing, labeling, batch record review and lot dispositionProvide direction for complex deviations and other investigations and CAPAs in support of batch release, inspection readiness and regulatory findings including tracking closure of compliance issuesIndependently perform and/or manage batch release activities for commercial and clinical production including but not limited to review of batch records, analytical data, certificates of analysis, and other documents (e.g., method validation protocols/reports, product specifications, change controls, etc.) as needed for consistency with applicable regulations and for compliance with company's GMP Quality SystemProvide status reports, including relevant quality metrics and participate in the management review processIdentify and support continuous improvement projects in collaboration with CMC, QC and RA to achieve quality, reliability and efficiency improvement objectivesSupport or lead implementation and upgrades of digital tools and systems supporting QualityManage quality assurance team and consultants, as assignedEstablish collaborative relationships with internal and external stakeholders to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely mannerEstablish internal SOPs applicable to internal functions as well as outsourced functionsAssist in any Regulatory inspections’ readinessEstablish and ensure that policies at Rigel and CMOs adhere to cGMPs, and regulatory requirements of FDA, EMA and other regulatory agencies as requiredOversee QA Review of process validation protocols, validation data and validation reportsProvide quality assurance support in the technology transfer, scale-up, validation and manufacturing at CMO.Manage assigned QA operation tasks in accordance with Rigel’s SOPs (e.g., trending report, training program)Independently interact with other groups to proactively address compliance concerns and resolve problemsAble to participate in cross-functional compliance improvement projectsPerform internal and external audits· Able to work with electronic and paper-based systemsADDITIONAL RESPONSIBILITIES:Perform Annual Product ReviewsAbility to file Field Alert Reports (FAR)Develop Quality Management SystemsKNOWLEDGE AND SKILL REQUIREMENTS:Minimum BS/BA in Chemistry, Biology or other relevant discipline12+ years QA or equivalent experience in the Pharmaceuticals/ or Pharma and Device, and at least 4 years of leadership and management experiencePrior hands-on experience establishing and/or maintaining a document control system is required. Experience with implementing new technologies is preferred.Prior working experience maintaining training program activitiesStrong understanding of cGMPs (21 CFR 210, 211), ICH guidelines and ISO conceptsUnderstanding of basic scientific/technical conceptsGood analytical skillsClear, concise writing skills and good verbal presentation skills. Including but not limited to Word, Excel, MS Office and SharePointExcellent organizational skills and attention to detailAbility to interact constructively and efficiently with co-workersWorks on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factorsExercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.Demonstrates strong understanding of procedures and methods for review functionPAI readiness or BIMO readiness are preferredAbility to work under tight deadlinesMay participate on project teams and actively participate in cross-functional compliance improvement projectsWorks under only general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectivesHands-on experience and proficiency in writing Deviations, Change controls, CAPAs, Investigations, SOPs and other controlled documentsWORKING 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