Sr Specialist QA - Compliance
Amgen
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Upgrade to Pro — $25/moJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr Specialist QA - Compliance
What you will do
Let’s do this. Let’s change the world. In this vital role you will coordinate all site logistics for regulatory inspections, corporate audits, internal audits, and customer audits across both manufacturing facilities. Also serve as a 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative leader with these qualifications.
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
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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.
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