Quality Assurance Senior Manager

Amgen SA; Puerto Rico; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Retirement and Savings Plan

Comprehensive benefits package

Job summary

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality oversight of primary component suppliers and collaborate with cross-functional teams across operations, process development, supply chain, and manufacturing. The role emphasizes regulatory compliance, audits, and risk management to ensure high-quality materials for patients.

You will lead supplier quality programs, prepare sites for regulatory inspections, and drive continuous improvement initiatives while partnering with

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate’s, or High School with extensive quality experience.
• 10+ years biotech/pharma experience preferred.
• Experience overseeing supplier quality and leading audits.
• Strong knowledge of GMP GDP ISO and regulatory expectations.

Responsibilities

• Quality lead for supplier relationships from onboarding to disengagement.
• Ensure compliance with GDP, GMP, ISO and Amgen standards.
• Negotiate and own quality agreements.
• Prepare sites for inspections and develop inspection playbooks.
• Represent Amgen at supplier inspections and audits.
• Review and approve supplier investigations and deviations.
• Drive supplier audit preparation and closure.

Skills

Quality management

Supplier relationships

Audit leadership

Regulatory knowledge

Risk assessment

Cross-functional leadership

Project management

Data analytics

Stakeholder influence

GMP GDP ISO knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Trackwise

Veeva

Job description

Join 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Quality Assurance Senior Manager

What you will do

Let’s do this. Let’s change the world. This QA Sr. Manager role will be responsible for the quality oversight of primary component suppliers. This person is an integral member of the Amgen cross-functional supplier team(s) that includes, but is not limited to, business operations, process development, supply chain and combination product quality.

Key Responsibilities:

• Act as the quality lead for supplier relationships, from onboarding through disengagement, ensuring performance through robust proactive monitoring, technical site visits, and continuous improvement.
• Perform proactive quality management of suppliers, ensuring compliance with global regulatory standards, including but not limited to GDP, GMP, ISO, etc and Amgen’s industry leading expectations.
• Negotiator and owner of quality agreements
• Prepare external sites for inspections including development of inspection playbooks.
• Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required
• Present on topics during inspections demonstrating appropriate behaviors and knowledge of the subject areas
• Review/Approve supplier investigations, events and change notifications
• Quality approver of deviations, change controls, CAPA, CAPA EVs
• Identify and mitigate risk at the supplier and/or elevate to management
• Perform Person in Plant activities, as deemed appropriate
• Drive audit commitments to completion
• Lead supplier audit preparation and identify areas of focus
• Continuously assess supplier status through periodic monitoring reporting
• Partner with Operations site lead on issues, improvements, site performance and overall relationship management
• Understand and implement GMP requirements internally and externally

The follow applies:

• Up to 20% of domestic and international travel required
• This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, Tampa, FL, or Puerto Rico.
• Open to remote associates in any US location

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 individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Quality experience OR
• Master’s degree and 4 years of Quality experience OR
• Bachelor’s degree and 6 years of Quality experience OR
• Associate’s degree and 10 years of Quality experience OR
• High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:

• 10+ years biotech or pharmaceutical industry experience
• 5+ years of experience overseeing quality of suppliers
• Experience with leading audits
• Technical knowledge related to primary components
• Experience with Quality Processes and systems such as Trackwise and Veeva
• Experience with quality oversight of primary components
• History of presenting during inspections and audits
• Able to facilitate and influence senior stakeholders and partners
• Able to successfully prioritize workload and meet timelines
• Ability to negotiate a strategic position after receiving feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Demonstrated ability to lead cross-functional teams, consistently deliver timely, and high-quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience with relationship management with external parties
• Savvy with data and Artificial Intelligence tools

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.

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.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.