Director of Quality Assurance - GMP Manufacturing (Synthetic APIs) at Cambrex in Waltham, Massachusetts

Job Description:

Cambrex


Director of Quality Assurance - GMP Manufacturing (Synthetic APIs)

US-MA-Waltham

Job ID: 2025-4052
Type: Regular Full-Time
# of Openings: 1
Category: Quality Assurance
Cambrex - Waltham

Overview

About the Company

Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where synthetic chemistry underpins product development.

We rely on our most valuable resource – our people – to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in flow chemistry and product development while also cultivating and furthering your career. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture.

Job Description

Snapdragon Chemistry is currently seeking exceptional candidates for its Director of Quality Assurance - GMP Manufacturing (Synthetic APIs) position. A successful candidate will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing.

We are seeking a highly experienced and motivated individual to join our Contract Development and Manufacturing Organization (CDMO) as the Director of Quality Assurance (QA). This leadership role is responsible for overseeing all aspects of Quality Assurance in a GMP manufacturing environment for synthetic Active Pharmaceutical Ingredients (APIs), ensuring compliance with regulatory requirements and industry standards. The ideal candidate will have over 10 years of relevant experience in clinical and commercial settings, with a strong preference for those with a technical background in manufacturing or Quality Control (QC).

This role offers a unique opportunity to lead the Quality Assurance function at a dynamic and growing CDMO, contributing to the production of high-quality APIs for clinical and commercial use. The successful candidate will play a critical role in ensuring the organization's compliance, operational excellence, and customer satisfaction.

Responsibilities

• Lead and manage the Quality Assurance team, ensuring adherence to GMP regulations and internal quality policies.
• Oversee QA activities related to both clinical and commercial manufacturing of synthetic APIs, including batch review, testing, disposition OOS and deviation management.
• Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH) for API manufacturing and quality systems.
• Develop, implement, and maintain Quality Management Systems (QMS) to support clinical and commercial manufacturing.
• Provide strategic guidance and leadership during regulatory inspections, client audits, and internal quality reviews.
• Responsible for both internal audit program and external vendor qualification.
• Responsible for site Master Control function and training.
• Collaborate with cross-functional teams, including Facilities, Manufacturing, QC, and R&D, to ensure seamless integration of quality practices.
• Investigate and resolve quality issues, including deviations, non-conformances, and customer complaints.
• Monitor quality metrics and implement continuous improvement initiatives to enhance compliance and efficiency.
• Ensure proper training and development of QA staff to maintain a high-performing team.
• Serve as a primary quality contact for clients, ensuring alignment on quality standards and expectations.
• Participate in cross site Quality function team meetings to ensure QA alignment across Cambrex locations.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 10+ years of experience in Quality Assurance within a GMP manufacturing environment for synthetic APIs.

PI259234129

Salary:

$150,000.00

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