Sr Specialist QA - Compliance

Key Responsibilities Coordinate all site logistics for regulatory inspections, corporate audits, internal audits, and customer audits across both manufacturing facilities. Serve as the primary site coordinator for inspection readiness activities, including planning rooms, schedules, escorts, subject‑matter expert support, document retrieval processes, communications, and daily inspection management. Partner across functions to maintain a continuous inspection‑ready state for a multi‑product GMP manufacturing operation. Develop, maintain, and continuously improve site inspection readiness programs, tools, trackers, playbooks, and governance processes. Coordinate cross‑functional readiness plans for upcoming Health Authority inspections and major audits, including mock inspections, war‑room preparation, document review, and interview readiness. Support inspection and audit strategy for new product introductions to ensure new processes, facilities, systems, documents, and personnel are inspection ready prior to implementation and filing‑related activities. Ensure inspection‑related commitments, actions, and deliverables are clearly assigned, tracked to completion, and escalated as needed. Facilitate cross‑functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination. Support preparation and maintenance of core inspection readiness content, including site overviews, facility maps, product flow summaries, SME rosters, document inventories, and inspection support tools. Coordinate document management and retrieval processes to support efficient and controlled responses during inspections and audits. Monitor readiness of quality systems and operational processes that are commonly scrutinized during inspections, including deviations, CAPAs, change control, complaints, training, validations, document management, and data integrity controls. Identify gaps, risks, or weak points that may affect inspection outcomes and work with functional owners to drive timely remediation. Support site self‑assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends. Develop and sustain close working relationships with internal stakeholders and external business partners, to ensure aligned and effective audit and inspection support. Ensure lessons learned from prior inspections, audits, commitments, and industry enforcement actions are incorporated into site readiness activities. Track regulatory commitments and support timely follow‑up to ensure inspection observations, actions, and commitments are completed and sustainable. Provide compliance support during inspections, including schedule management, room coordination, request tracking, communication support, and facilitation of cross‑functional issue resolution. Support drafting, coordination, and review of inspection responses and related action plans, as applicable. Escalate significant quality, compliance, supply, and inspection readiness risks to site quality and senior leadership. Support continual improvement initiatives that strengthen site quality culture, inspection readiness capability, and execution discipline. Basic Qualifications High school diploma / GED and 12 years of regulatory compliance experience OR Associate’s degree and 10 years of regulatory compliance experience OR Bachelor’s degree and 6 years of regulatory compliance experience OR Master’s degree and 4 years of regulatory compliance experience OR Doctorate degree and 2 years of regulatory compliance experience. Preferred Qualifications Bachelor’s Degree in Life Sciences or Engineering. Experience with leading and/or participating in key roles to prepare for, execute and/or respond to outcomes from Health Authority inspections. Experience in auditing and/or defending processes, procedures and decisions during Health Authority inspections. 7+ years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems. Experience managing staff and/or leading cross‑functional teams, projects and/or programs. Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs). Thorough understanding of quality management systems and quality control processes related to bulk drug substance for commercial operations. Previous exposure to bulk drug substance manufacturing and quality assurance processes. Demonstrated ability to work autonomously, present data in an organized and logical manner and an ability to communicate effectively. Demonstrated ability to navigate through ambiguity and provide a structured problem‑solving approach. Track record of building or participating as a member of successful teams. Demonstrated ability to coordinate and lead cross‑functional project teams to deliver to expectations and on schedule. Benefits The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include a comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts, a discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible. Equal Employment Opportunity Statement Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr Amgen