Manager PQA (Night Shift 12 hour) (6pm-6am)

Amgen•New Albany, OH

1d•$118,235 - $159,965

About The Position

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. 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. Manager PQA What you will do Let’s do this. Let’s change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function—it’s a mindset. We’re seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety. This is more than a role, it’s an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide. Lead Quality. Inspire Excellence. Impact Patients. As a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems. Key responsibilities include: Lead, coach, and develop Quality staff across assigned areas and shifts Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards Review, approve, and oversee key quality systems including: Deviations CAPAs Change Controls Validation documentation Procedures and batch records Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes Ensure production records and test results are accurate, complete, and inspection-ready Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders Assess and manage quality risks, escalating critical issues to senior leadership as needed Represent QA during internal and external audits and regulatory inspections Support audit readiness and participate in inspection management activities Ensure document control excellence, including ownership and timely periodic review of controlled documents Foster a culture of quality, accountability, and compliance across all teams

Requirements

Doctorate degree
Master's degree and 3 years of quality experience
Bachelor's degree and 5 years of quality experience
Associate's degree and 10 years quality experience
High school diploma / GED and 12 years of quality experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

Bachelor's degree in Life Sciences, Engineering, or a related field (advanced degree a plus)
3+ years of experience in Quality Assurance within a GMP-regulated environment (biotech/pharma preferred)
Prior leadership or people management experience strongly preferred
Deep knowledge of cGMP, GDP, and regulatory expectations
Proven experience with quality systems (deviations, CAPA, change control, validation)
Strong ability to lead in a shift-based operation, with flexibility for evenings, nights, weekends, or holidays
Excellent communication, decision-making, and problem-solving skills
A proactive, collaborative leader who can influence and inspire across functions

Responsibilities

Lead, coach, and develop Quality staff across assigned areas and shifts
Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
Review, approve, and oversee key quality systems including: Deviations, CAPAs, Change Controls, Validation documentation, Procedures and batch records
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Ensure production records and test results are accurate, complete, and inspection-ready
Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
Assess and manage quality risks, escalating critical issues to senior leadership as needed
Represent QA during internal and external audits and regulatory inspections
Support audit readiness and participate in inspection management activities
Ensure document control excellence, including ownership and timely periodic review of controlled documents
Foster a culture of quality, accountability, and compliance across all teams