Sr Specialist Quality Compliance

Amgen • West Greenwich, RI

6d • $132,037 - $178,639

About The Position

The Sr Specialist QA - Compliance provides site-level leadership for inspection readiness across two manufacturing facilities. The role drives sustained readiness for regulatory inspections, corporate and internal audits, and customer audits by developing readiness strategies, establishing governance and accountability, identifying risks, and aligning cross-functional partners. As a primary site coordinator, the position manages inspection logistics, including schedules, rooms, escorts, subject matter expert support, document retrieval, communications, and daily inspection activities, adapting plans and resources as priorities evolve.

The position also supports inspection and audit readiness for new product introductions; monitors quality systems and operational processes commonly scrutinized during inspections; identifies gaps and drives remediation; and coordinates regulatory commitments, inspection responses, and action plans. It contributes to stronger site quality culture and continual improvement through assessments, lessons learned, and cross-functional coordination.

Requirements

• One of the following education and regulatory compliance experience combinations: high school diploma or GED and 12 years; associate’s degree and 10 years; bachelor’s degree and 6 years; master’s degree and 4 years; or doctorate degree and 2 years.
• Ability to work autonomously, present data in an organized and logical manner, and communicate effectively.
• Ability to identify compliance risks and readiness gaps, lead cross-functional remediation, and ensure actions are completed and sustained.
• Thorough working knowledge of EU and US Good Manufacturing Practices (cGMPs).
• Ability to navigate ambiguity and provide a structured problem-solving approach.

Nice To Haves

• Bachelor’s degree in Life Sciences or Engineering.
• 7 or more years of related work experience in pharmaceutical manufacturing, process development, or quality assurance, with progressively increasing responsibility and demonstrated experience in compliance, data analysis, project management, and quality systems.
• Experience leading or coordinating inspection and audit activities, including managing information requests, preparing subject matter experts, supporting interviews, and coordinating inspection responses.
• Experience leading or participating in key roles to prepare for, execute, and/or respond to Health Authority inspections.
• Experience auditing and/or defending processes, procedures, and decisions during Health Authority inspections.
• Strong working knowledge of cGMP requirements and quality systems commonly assessed during inspections, including deviations, CAPAs, change control, training, validation, document management, and data integrity.
• Experience managing staff and/or leading cross-functional teams, projects, or programs.
• Previous exposure to bulk drug substance manufacturing and quality assurance processes.

Responsibilities

• Partner across functions to maintain a continuous inspection-ready state for a multi-product GMP manufacturing operation.
• Develop, maintain, and improve site inspection readiness programs, tools, trackers, playbooks, and governance processes.
• Coordinate cross-functional readiness plans for 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, ensuring new processes, facilities, systems, documents, and personnel are inspection ready before implementation and filing-related activities.
• Assign, track, and escalate inspection-related commitments, actions, and deliverables.
• Facilitate cross-functional alignment on inspection narratives, site presentations, supporting data packages, and response coordination.
• Prepare and maintain 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 for controlled, efficient responses during inspections and audits.
• Monitor readiness of quality systems and operational processes commonly scrutinized during inspections, including deviations, CAPAs, change control, risk management, complaints, training, validations, document management, and data integrity controls.
• Identify gaps, risks, and weak points that may affect inspection outcomes and work with functional owners to drive timely remediation.
• Facilitate and manage monthly management review.
• Support site self-assessments and gap assessments against cGMP requirements, internal standards, and regulatory inspection trends.
• Build and sustain working relationships with internal stakeholders and external business partners to support aligned audit and inspection activities.
• Incorporate lessons learned from prior inspections, audits, commitments, and industry enforcement actions 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 cross-functional issue resolution.
• Support drafting, coordination, and review of inspection responses and related action plans.
• 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.

Benefits

• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED