Role Summary
The Senior Specialist will be responsible for the processing and maintenance of the Quality System records supporting GMP activities. These records include quality events, deviations, investigations, CAPA, change controls, and complaints for R&D and Late Phase/Commercial GMP activities. This role reports to the Senior Manager, Product Complaints & Quality Systems and supports Global Product Quality and cross-functional partners to assure robust QMS records and inspection readiness. This position will also receive, document, investigate, resolve and respond to product quality complaints and other post-market feedback.
Key Responsibilities
Maintain and review Quality Events, Deviations, Investigations, CAPAs, Change Control, and Product Quality Complaints for R&D and Late Phase/Commercial GMP activitiesReview investigations to assure they are robust, properly documented (including root cause analysis, product quality impact assessment, CAPA), and adhere to proceduresWrite internal/vendor Change Controls, Quality Events, Deviations, Investigations, CAPA, and Product Quality Complaints and ensure they are properly documented in Veeva and inspection readyMaintain product quality complaint handling (documentation, coordination, investigation, resolution, closeout) and investigation processes for R&D and commercial products in compliance with regulatory requirements (21 CFR 210, 211) and internal proceduresEscalate critical complaints, quality events, trends to senior management timely, per procedureParticipate in the qualification, onboarding, and product training of call center for handling of commercial product quality complaintsSupport Annual Product Reviews as they relate to Quality System records. Support any potential stock recovery/recall, and/or field alert/field correction activities, if neededWork with internal stakeholders to establish and maintain feedback systems and other post-market surveillance processesParticipate in internal audits and health authority inspections as required for the scope of work associated with this roleSupport GMP quality systems by driving regulatory compliance in accordance with applicable regulations and business objectivesAdditional Quality projects and responsibilities may be assigned based on the business needs of a growing organizationRequired Qualifications
At least 5 years of relevant Quality System experience in a pharmaceutical industry supporting clinical and/or commercial productsTechnical writing experience; writing investigations, performing root cause analysis, and identifying CAPAsExperience working in an electronic quality management system (Veeva or equivalent)Understanding of GMP requirements and the drug development processAbility to handle interactions and resolve issues with internal customers in a tactful, professional, and effective mannerStrong verbal and written communication skills to effectively communicate with cross functional business partnersHighly motivated, flexible, and able to respond quickly to shifting priorities. Able to meet deadlines, with excellent organizational skills and keen attention to detailsAbility to partner and build relationships with technical operation stakeholders and external vendors to enable high quality outcomesAbility to travel to Cerevel Headquarters in Cambridge, MA – may be up to 20%Desired Qualifications
ASQ certification, or equivalentSmall molecule experienceStrong team player with a solutions-oriented, customer-service, and continuous improvement mind-setEducation
Bachelor’s degree in life science or engineering field
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