RCI-PFE-5219 Senior Associate (Contractor Quality & Compliance)

Position Summary This role is for a Senior Associate (Contractor Quality & Compliance) supporting oversight of external Contract Manufacturing Organizations (CMOs).The individual will ensure product quality, regulatory compliance, and operational alignment between external partners and internal teams.The position should be based in the United States, ideally in the Eastern Time Zone, to enable better collaboration with global stakeholders.The primary CMO supported is located in Canada, with additional interaction across global teams.Day-to-Day ResponsibilitiesOversee quality and compliance activities for assigned CMOsReview and manage change controls (from CMO to company and vice versa)Handle and coordinate product complaints, including:Initiating and reviewing investigationsAssessing feedback and resolutionManage and review deviations reported by CMOsReview and approve:Annual Product Quality Reviews (APQR)Stability protocols, reports, and dataAct as a key liaison between Regulatory and CMOs, including:Supporting document requests (e.g., Certificates of Analysis, Certificates of Compliance)Coordinating with internal regulatory teams and country officesSupport regulatory submissions and variations in collaboration with internal stakeholdersProvide ongoing oversight of product quality performance and compliance adherence Must-Have Qualifications & SkillsExperience in GxP environment (GMP/GDP preferred)Strong background in:Quality assurance and complianceChange control managementDeviation and complaint handlingExperience working with CMOs or external manufacturing partnersKnowledge of:Product quality reviews (APQR/PQR)Stability data and protocolsFamiliarity with regulatory processes and documentationAbility to act as a cross-functional liaison (quality, regulatory, external partners)Strong communication and stakeholder management skillsAbility to work independently and in a global environmentComfortable working across multiple time zones. Career page link: https://talentarbor.com/job/details/138551/3/652/senior-associate--contractor-quality---compliance--new-york-ny-us