Services Careers - Manager, QA Supplier Quality

Position: INCOG BioPharma Services Careers - Manager, QA Supplier Quality
We invite you to join our growing team!

Are you a quality assurance leader with supplier management expertise looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?

We are looking for a Manager of Supplier Quality Assurance who will help with leading a world-class supplier quality program while driving operational excellence in our rapidly expanding aseptic filling operations. Do you naturally create new ways to deliver exceptional results? We want to meet you!

INCOG's Why:
Patient Impact

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, we are more than just a contract development and manufacturing organization. We are a company born out of a simple idea-that there has to be a better way. A better way to work with our customers. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are-a dedicated team that believes we can always be better.

Join us in building a new world-class CDMO for parenteral injectable drugs and shaping a new future for patients for yourself, our clients, and patients.

Working at INCOG

We VALUE excellence, innovation, accountability, partnership, transparency, and results. We strive to be different putting our team at the forefront of everything we do and every decision we make. At INCOG, we are actively creating a culture where our team members are encouraged to be innovative, service-oriented, and collaborative problem solvers who are dedicated to meeting the challenges of working at a high-growth company.

We are committed to empowering our employees to be their best and to making INCOG a rewarding and fun place to work.

We truly believe that every employee contributes to the success of the company, and you can be part of that team.

Our Values (ALP)

All IN

* Patient Impact

* Bring a positive attitude and best efforts, every day

* Company commits to your growth and success, professional and personal

LEAN FORWARD

* Have a bias for action

* Be service-centric and solution-oriented

* Welcome challenging projects and timelines

* Work to be flexible with well designed systems and protocols

PULL FOR THE TEAM

* Our customers' success comes first

* Treat others with respect; help rather than criticize

* Celebrate the wins!

Manager, Supplier Quality Assurance

- Job Summary

As Manager of Supplier Quality Assurance, you'll be at the forefront of expanding our supplier quality program and leading supplier quality management for all types of biologic drugs for our clients. This is a unique opportunity to shape quality systems, develop a high-performing team, and drive continuous improvement initiatives that directly impact patient safety and product quality. You'll work alongside passionate professionals in a collaborative environment where innovation meets rigorous GMP standards, and where your expertise will be valued and your career growth accelerated.

This role encompasses comprehensive responsibility for all aspects of supplier quality assurance, including vendor qualification and management, incoming material inspection programs, supplier auditing, and CAPA management. You'll lead the development and implementation of robust quality systems that ensure compliance with FDA, EMA, and other regulatory requirements while supporting our rapidly growing aseptic filling operations. The successful candidate will build and mentor a team of quality professionals, drive process improvements for enhanced efficiency, and establish strategic partnerships with key suppliers to ensure consistent delivery of high-quality materials and services.

Essential Job Functions:

* Team Leadership & Development:
Build, lead, and mentor a team of supplier quality professionals, establishing clear performance objectives, providing ongoing coaching, and fostering a culture of continuous improvement and regulatory compliance

* Supplier Qualification & Management:
Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services

* Quality Systems Ownership:
Maintain robust supplier quality management systems, including vendor approval processes, incoming inspection protocols, and supplier scorecards aligned with GMP requirements

* Regulatory Compliance:
Ensure all supplier quality activities comply with FDA and EMA regulations, ICH guidelines, and other applicable regulatory standards

* Supplier Auditing:
Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up

* Process Improvement:
Identify and implement process improvements to enhance efficiency, reduce cycle times, and…