Quality Control Manager

QC Manager

Greater Boston, MA

$120,000 - $150,000 | Full-time, Permanent

Are you passionate about quality and science? This opportunity could be your next big step to contribute to cutting-edge advancements. Join a pioneering team where your expertise in bioassays will make a meaningful impact on life-changing therapies.

About the Company

This biotech organization specializes in the development and production of therapeutic solutions. They offer a range of services, including process development and GMP manufacturing to support clinical research. Committed to innovation and quality, this company aims to meet the specific needs of clients in the biopharmaceutical sector. It fosters a collaborative culture, empowering employees to creatively address complex challenges. By prioritizing patient outcomes, the organization seeks to contribute significantly to the advancement of new treatments and therapies.

The Team

As QC Manager, you’ll lead a highly skilled Quality Control team specializing in Bioassay. Managing a team of four or more analysts, you’ll collaborate with cross-functional departments to ensure quality and efficiency in a fast-paced environment. Known for fostering a culture of teamwork and growth, this group is focused on excellence and continuous improvement.

What You’ll Do

In this role, you’ll oversee daily operations within the QC Testing group, supporting clinical and commercial products. Reporting to the Director of QC Operations, your core responsibilities include:

• Maintain a safe, efficient, and compliant cGMP laboratory, ensuring adherence to regulatory, corporate, and site guidelines.
• Manage day-to-day QC lab operations, overseeing routine and non-routine testing of in-process materials, drug substances, and final products.
• Lead and approve validation protocols for instruments and equipment, including routine preventative maintenance and annual operational qualifications.
• Ensure QC equipment remains validated and compliant, maintaining logbooks and managing any non-conformance events.
• Oversee inventory and management of critical reagents, controls, and lab supplies.
• Support method validation and analytical technology transfers, collaborating with QC Technical Services and QA teams.
• Initiate, review, and manage Quality Management Systems, including Change Controls, Deviations, Out of Specification events, and CAPA investigations.
• Author and review complex documentation, including SOPs, method protocols, reports, and regulatory submissions.
• Perform data trending, quality metrics (KPI) analysis, and risk assessments.
• Identify and implement process improvements to boost efficiency and compliance.
• Represent QC in cross-functional meetings, fostering collaboration and communication across departments.
• Train, coach, and develop QC staff to meet business needs and support their professional growth.

Skills You Will Need

• Extensive cGMP QC testing experience (10-15 years) in Bioanalytical/Bioassay, including at least 8 years of management experience
• Background in large molecules and human-derived cell culture
• Strong analytical and problem-solving skills, with a focus on compliance
• Excellent communication and organizational skills
• Proven ability to manage multiple tasks under challenging timelines and motivate team members

What’s on Offer?

• An opportunity to join a leader in the biotechnology field, making a direct impact on transformative therapies
• Competitive salary and an extensive benefits package, including a 401(k) match, health coverage, and share appreciation rights
• Paid time off, volunteer days, and wellness benefits to support work-life balance
• A values-driven, mission-focused culture that emphasizes innovation, integrity, and excellence

Call to Action

Take this opportunity to elevate your career in a rapidly growing industry. Apply today and become part of a team dedicated to advancing therapies that change lives. Interviews are ongoing, so don’t wait—send in your CV and take the next step in your career journey!