External Supply RMD QRO Specialist

Initial Therapeutics, Inc.; Columbus (OH); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Stock-based incentives

Flexible work models

Job summary

Amgen External Supply is seeking a highly skilled QRO Specialist to support the manufacturing network. You will own and close quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) and drive timely investigations and root-cause analyses to implement robust corrective actions.

You will collaborate with External Supply Quality, ES SRE teams, Amgen sites, and suppliers, ensuring compliance with KPI metrics and effective communication to senior management.

Qualifications

• Doctorate or Masters or Bachelor degree in a relevant field and 2+ years Quality/Manufacturing in pharma/biotech/medical devices.
• Experience with quality records (EN/SICAR, CAPAs, Change Controls) and regulatory compliance.
• Proficient with SAP/S4HANA or TrackWise/Veeva.
• Strong cross-functional collaboration and project-management skills.

Responsibilities

• Own, manage, and close quality records (EN/SICAR, Change Controls, Deviations, CAPAs).
• Lead root-cause investigations and implement effective corrective actions.
• Collaborate with External Supply Quality, ES SRE, Amgen sites, and suppliers.
• Present quality record status updates to senior management.

Skills

Quality records

CAPA management

Root cause analysis

Cross-functional collaboration

SAP / ERP systems

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Tools

TrackWise

Veeva System

SAP / S4HANA

Microsoft Office

Job description

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. 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, 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.

External Supply RMD QRO Specialist

What you will do

Lets do this. Lets change the world. In this vital role you will play a vital role in supporting the Amgen manufacturing network. Our work includes managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, sites, and managing life-cycle changes to existing materials or suppliers. The External Supply QRO Specialist is expected to own and execute independently all the processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications. This Specialist Manufacturing will act as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner. The Specialist Manufacturing External Supply owns and manages quality records originating from manufacturing sites across the global Amgen network.

• Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
• Facilitation of cross-functional teams (internal and external to the site) with the goal of achieving robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
• Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
• Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions by effectively utilizing advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.).
• Manages closure of multiple quality records simultaneously and in a timely matter (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
• Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics.
• Build and present quality record summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management in multiple forums and keeping tracking tools updated.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree
• Masters degree and 2 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device industries experience
• Bachelors degree and 4 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device experience
• Associates degree and 8 years of Quality and/or Manufacturing in the pharmaceutical, biotech or medical device experience
• High school diploma / GED and 10 years Quality and/or Manufacturing in the pharmaceutical, biotech or medical device experience

Preferred Qualifications:

• 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Experience in devices and primary and secondary packaging materials
• Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System
• Demonstrated proficiency in managing change controls in alignment with quality system requirements, regulatory expectations, and business timelines
• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Experience presenting to and interacting with representatives of regulatory agencies.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Experience navigating and executing transactions in SAP (ERP) or S4HANA system.
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Demonstrated ability to deliver results through living the Amgen values.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues at other Amgen sites.

What you can expect from 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.

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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.