Quality Assurance Manager

Job Title: Quality Assurance Manager

Job Description

The Quality Assurance Manager will work closely with manufacturing to ensure product quality planning, design, and improvement, integrating quality into manufacturing processes. This role supports both internal audits and external vendor audits, leading these audits and providing necessary reports and documentation. Responsibilities also include performing change control assessments to Quality Systems, approving deviations and CAPAs, and acting as a Quality Subject Matter Expert in various meetings. The manager will also manage the QA review of Batch Records, oversee the SOP review processes, communicate regulatory changes effectively, and interact with Regulatory Affairs to ensure compliance with domestic and international standards.

Hard Skills

• Quality Systems assessments

• Audit leadership

• Regulatory submissions

• SOP review

• CAPA management

• Batch Record review

Soft Skills

• Effective communication

• Leadership

• Problem-solving

• Attention to detail

Work Site

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

Work Environment

The work environment includes lab settings with one direct report

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 for other accommodation options.