Senior Manager Corporate Quality Compliance

BioSpace; Washington (District of Columbia); Vor Ort; USD 150.000 - 180.000; Vollzeit

Benefits dieser Stelle

Remote and hybrid work options

Competitive benefits package

Zusammenfassung

Amgen seeks a Senior Manager, Global Quality Compliance to drive audits, inspections readiness, and quality initiatives across the enterprise.

You will lead audits of Corporate QA, sites, contract facilities, and affiliates, coordinate action plans, and support regulatory authorities when needed. Collaborative cross-functional work and travel are essential to success.

Qualifikationen

• Doctorate or master’s or bachelor’s degree with auditor experience plus minimum 2 years of people leadership experience.
• Certified Quality Auditor (CQA) or equivalent credential is preferred for senior-level QA roles.
• Experience with aseptic processing, drug product/substance, and data integrity is required.

Aufgaben

• Execute Global Quality Compliance audits of corporate QA management systems, sites, contract facilities, affiliates, suppliers, and partners to assess regulatory compliance and risks.
• Lead or participate in audit planning, training, and action plan assessments to correct deficiencies.
• Provide support for regulatory inspections and serve as a senior QA representative on cross-functional teams.

Kenntnisse

Aseptic Processing

Drug Product

Drug Substance

Combination Products

Data Integrity

Ausbildung

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Certified Quality Auditor (CQA) or equivalent

Jobbeschreibung

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Quality Compliance, Senior Manager

What you will do

Lets do this. Lets change the world.

Responsibilities

Responsible for executing Global Quality Compliance assigned tasks and/or projects necessary to achieve corporate and departmental goals including the following activities:

• Coordinates and leads or participates in Global Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, Critical Service Providers, Suppliers, Partners, and Wholesalers to assess compliance with all applicable regulations and to identify top compliance risks.
• Ensure completion, maintenance, and sustainability of the assigned training per specific roles to support the audit process (e.g., read and understand how to apply regulatory requirements including changes to regulations, guidelines and standards, trends and expectations, as applicable).
• Supports preparation of the annual audit plans, as assigned
• Assesses state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.
• Provides technical and organizational leadership toward resolving site and multi-site compliance issues.
• Alertsexecutivemanagementofsignificantquality,andcompliancerisks.
• Serves as subject matter expert on global regulated requirements and inspectional commitments, as applicable
• Provides support for domestic and international Regulatory Authority Inspections whennecessary.
• Serves as senior Global Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF, and special task forces) and interacts with other departments in order to achieve goals.
• Interactswithotherfunctional area leadstoensurethatAmgenStandards, strategies,anddirectionare alignedwithexistingregulationsandregulatoryexpectations.
• Provides support for audit and inspection metrics, as necessary.
• SupportsContinualImprovementinitiatives,programs,andprojects.
• Owns or performs QA approval for DQMS Quality Event records (Quality Incident, Deviation, CAPA, Change Control, EV for GQC and Audits & Inspections network as required).

Additional Requirements

• Experience with Aseptic Processing, Drug Product, Drug Substance, Combination Products, Data Integrity
• Certified Quality Auditor (CQA) or equivalent
• Travel: Domestic and International Approximately 50%

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 an employee with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of auditor experience OR
• Masters degree and 6 years of auditor experience OR
• Bachelors degree and 8 years of auditor experience OR
• Associates degree and 10 years of auditor experience OR
• High school diploma / GED and 12 years of auditor experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Auditing experience in internal audit, affiliate, CMO, Contract laboratory, Transportation/Logistic/Distribution/ warehouse services,
• 50 % international travel requirement
• Knowledge of international regulations and standards
• Auditing certification preferred
• Detail oriented
• Organizational and multi task skills

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, well 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, including remote and hybrid work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

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Application deadline

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.

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.