Sr. Manager, GMP Quality

Advanced Clinical; Marlborough (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability Insurance

401k benefits

Job summary

Advanced Group is seeking an experienced Quality Assurance professional to support quality and compliance activities within a regulated manufacturing environment in Marlborough, MA. The 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.

The position involves participation in cross-functional projects, review of manufacturing and testing

Qualifications

• Experience in a regulated industry (manufacturing, life sciences, healthcare, biotech, pharmaceuticals, medical devices)
• Knowledge of quality systems and regulatory requirements
• 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

Responsibilities

• Participate in cross-functional teams to support quality initiatives and projects.
• Review manufacturing, testing, and quality documentation for compliance.
• Support product release activities and quality oversight across the lifecycle.
• Collaborate with internal and external stakeholders to support manufacturing operations and quality improvements.
• Review and support validation and qualification activities, as applicable.
• Assist with maintenance and continuous improvement of quality systems and documentation.
• Support investigations, CAPA, change management, and other quality processes.
• Analyze quality data and metrics to identify trends and opportunities for improvement.
• Contribute to periodic quality reviews and compliance assessments.

Skills

Quality systems

Compliance knowledge

Documentation review

Analytical skills

Communication skills

Independent worker

Education

Bachelor's degree in scientific/engineering/technical field

Job description

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.

Key Responsibilities

Overview

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.

• 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.

MSPTalent

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

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [e-mail].