Senior Director, Quality Control at Quanterix in Billerica, MA

To continue our growth, we are seeking an experienced and accomplished Senior Director, Quality Control to join our growing organization. This position will be part of our Manufacturing Operations team and will implement, foster, and lead a culture of Total Quality Management within QC that supports current business priorities and enables the company's future growth. The position scope includes cost center management, QC asset management, and oversight of the QC Assay Transfer, Stability, Raw Materials and Assay Release teams. This position will be responsible for strategic oversight of the department within a highly cross-functional environment, in order to drive high quality product, high levels of customer service and compliance. The ideal candidate will be an innovative leader with experience in Lean principles in addition to a depth of experience in fast-paced Quality Control testing environments.

Key Responsibilities:

This role will be expected to:

• Recruitment, training, performance management, and professional development of Quality Control Testing personnel
• Provides strategic and operational management of a Quality Control department responsible for Assay Transfer, Stability, Raw Materials, and Assay Release
• Accountable for ensuring adherence to strict regulatory requirements to ensure product quality
• Works with the Assay Development, Supply Chain, Manufacturing, QA/Regulatory and more broadly across the Research Products, to ensure effective communication and resourcing across all groups
• Provides leadership for and ensures the effective transfer of NPIs to Quality Control in a phase-appropriate fashion, to support launch and commercialization activities.
• Ensures a science-driven, phase appropriate, and risk-based quality control strategies to support development projects and Menu expansion
• Contributes to authoring and/or reviewing QC reports, SOPs, SCPs, Protocols, comparability/bridging protocols and reports, justification of specifications, and relevant sections of regulatory filings
• Manages and mentors staff to build a highly functional QC team

Skill and Knowledge Requirements:

• Excellent organizational, record keeping and communication skill
• Demonstrated ability to work well within cross-functional teams as a team player
• Possess an ability to learn and master complicated concepts quickly and comfortably
• Ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude
• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports
• Team oriented and able to manage multiple projects across various development stages

Minimum Experience and Education:

• Bachelor’s Degree in a scientific discipline, Masters/PhD preferred
• 15+ years experience in medical device or life science industry
• 3+ years experience managing immunoassay Product Testing or Quality Control operations
• 5+ years of experience leading and managing high performance teams in a Quality Control setting
• Experience with GxP- and ISO-certified manufacturing and Quality Control operations preferred
• Experience with Risk Management and Validation required
• Experience with Lean Six Sigma Principals and Continuous Improvement a plus

Physical Demands:

• Some processes entail repetitive motion and extended periods of time in a standing position

Travel Requirements:

• <5%

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s digital health solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the continuum from health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognoses and enhanced treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation, and infectious disease.

Quanterix is committed to a diverse and inclusive workplace. Quanterix is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.