Senior Manager QA

Initial Therapeutics, Inc.; West Greenwich (RI); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player is seeking a Senior Manager of Quality Assurance to lead a dedicated team in ensuring quality oversight of commercial manufacturing. This pivotal role involves collaborating with various stakeholders, managing daily operations, and driving improvements within the quality management framework. With a focus on patient care and innovative solutions, you will play a crucial part in shaping the future of healthcare. Join a vibrant culture that values collaboration and professional growth, and make a significant impact on patients' lives while advancing your career in a supportive environment.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Discretionary annual bonus program

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Qualifications

• 12+ years in Quality, Manufacturing, or Process Development with leadership experience.
• Experience in managing multi-layered teams and regulatory inspections.

Responsibilities

• Lead PQA operations ensuring compliance and quality oversight.
• Collaborate with stakeholders to resolve issues and maintain inspection readiness.

Skills

Quality Management

Manufacturing Process Development

Leadership

Problem-solving

Communication Skills

Collaboration

Education

High school diploma / GED

Associate degree

Bachelor's degree

Master's degree

Doctorate degree

Tools

Quality Management Systems

Regulatory Inspection Processes

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. 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, 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.

Senior Manager QA

What you will do

In this vital role, you will lead a team of dedicated individuals responsible for the quality oversight of commercial manufacturing at Amgen Rhode Island. This role demands a proactive and autonomous leader with an overall understanding of quality, compliance, and operations.

The Sr. Manager of Plant Quality Assurance (PQA) plays a critical role supporting commercial production, volume-driven growth, and advancing strategic priorities in Amgen Rhode Island (ARI). The Plant Quality Assurance team provides 24-hour, 7-day a week coverage of the AR30 manufacturing operations. The team works on the floor and interacts broadly across the site, which provides visibility and opportunity to influence outside of your function.

Key responsibilities include:

• Provide oversight to PQA daily operations, ensuring the team is supporting deliverables and following guidelines for general policies.
• Represent Quality Assurance on incident triage teams by providing guidance and technical leadership for key decision-making.
• Partner with clients and stakeholders at various management levels across the organization to resolve issues, maintain compliance, and ensure inspection readiness.
• Collaborate with Quality peers to drive improvement and align at site and network level.
• Develop agile and resilient Quality professionals.
• Develop and monitor functional areas goals in alignment with site and network strategic priorities.

What we expect of you

The collaborative professional we seek is a leader with these qualifications:

Basic Qualifications:

• High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Associate degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Bachelor's degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Master's degree and 6 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Doctorate degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering 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 of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• Previous management experience with multi-layered teams.
• Demonstrated abilities in problem-solving.
• Excellent written and verbal communication skills.
• Strong collaboration and partnership skills at various levels of management.
• Understanding of quality management systems.
• Proven ability to negotiate cross-functionally and make informed risk-based decisions.
• Experience with regulatory inspections.

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, including remote and hybrid work arrangements, where possible.

Apply now

for a career that defies imagination

Join us.

careers.amgen.com

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.