Sr. Manager, GMP Quality

About the role

Seeking an experienced Quality Assurance professional to support quality and compliance activities within a regulated manufacturing environment. This role partners with cross-functional teams and external service providers to ensure products are manufactured, tested, and released in compliance with applicable quality standards and regulatory requirements.

Responsibilities

• Participate in cross-functional teams to support quality-related initiatives and projects.
• Review manufacturing, testing, and quality documentation to ensure compliance with established requirements.
• Support product release activities and quality oversight throughout the product lifecycle.
• Collaborate with internal and external stakeholders to support manufacturing operations, process improvements, and quality initiatives.
• Review and support validation and qualification activities, as applicable.
• Assist with the maintenance and continuous improvement of quality systems, procedures, and documentation.
• Support investigations, corrective and preventive actions (CAPA), change management activities, and other quality processes.
• Analyze quality data and metrics to identify trends and opportunities for improvement.
• Contribute to periodic quality reviews and compliance assessments.
• Perform additional responsibilities as assigned.

Qualifications

• Experience working within a regulated industry, preferably in manufacturing, life sciences, healthcare, biotechnology, pharmaceuticals, medical devices, or a similar environment.
• Knowledge of quality systems, compliance requirements, and industry best practices.
• Experience reviewing technical documentation and participating in quality-related decision making.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Experience supporting process improvement initiatives is preferred.

Education & Experience

Bachelor's degree in a scientific, engineering, technical, or related discipline, or equivalent combination of education and experience. Several years of professional experience in quality assurance, quality control, compliance, manufacturing, operations, or a related field.

Benefits

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.