Job Title: Quality Control Manager, Critical Reagents

Job Description

Summary of the Position:

The QC Manager, Critical Reagents is responsible for managing the reference standards and critical reagents in compliance with internal SOPs and ICH guidelines. The Manager, Critical Reagents must demonstrate strong leadership, as well as statistical and technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance, and scientific excellence.

This position will report into the Associate Director, Analytical Services and be a part of the Quality Control Extended Leadership team.

Responsibilities include but are not limited to:

• Manage and oversee the Critical Reagents and Reference Standards function

• Manage and oversee operational oversight for critical reagent management across the organization working closely with manufacturing network of internal and external testing sites and manufacturing partners (CMOs/CTLs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial

• Manage and lead the development of robust systems for the selection, qualification, monitoring, tracking, and storage of critical reagents to ensure delivery of quality products to our patients worldwide

• Manage and lead building, developing, and coaching a team that can deliver continued supply of critical reagents and reference standards to both internal and external testing locations such as CMOs and OTLs

• Manage and oversee development and establish new strategic capabilities for our global inventory management systems

• Primary point of contact and owner for management of a robust system for the monitoring, tracking, and storage of critical reagents to ensure quality and commercial supply availability.

• Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices

• Oversee and support preparation of regulatory submissions, oversight during inspections and audits, and respond to questions from regulatory bodies within in the scope of critical materials and reference standards

• Collaborate with cross-functional teams to develop risk assessments and mitigation strategies for critical reagents

• Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials

Hard Skills

• Quality Control

• Critical Reagent

• Analytical Methods

• Method Validation

Soft Skills

• Leadership

• Initiative

• Commitment to Quality

• Compliance

• Scientific Excellence

Job Type

This is a permanent position.

Work Site

This is a fully on-site position in Germantown, Maryland.

Work Environment

Lab, and office

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.