Senior Quality Assurance Lead - GMP Compliance & Audits

Artech Information System LLC; Canton (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A major IT staffing company is seeking a Quality Compliance Investigator to manage and lead investigations into GMP operations. The candidate will support internal and external audits, ensure compliance with CGMP standards, and track corrective actions effectively. With a strong focus on compliance and organization, the ideal applicant must possess exceptional analytical, communication, and interpersonal skills, along with a solid background in quality and biopharmaceutical experience. This role is crucial for maintaining stringent quality requirements in the fast-paced pharmaceutical environment.

Qualifications

• Master’s Degree in Engineering or Life Sciences with 5 years of relevant experience.
• Bachelor’s Degree in Engineering or Life Sciences with 7 years of relevant experience.
• 12+ years of relevant industry experience.
• Previous experience in biologics, biotechnology, pharmaceutical or biopharmaceutical sectors.

Responsibilities

• Investigate GMP operational non-conformances.
• Lead investigation teams and provide guidance on deviations.
• Make recommendations for process improvements.
• Ensure inspection readiness and compliance with CGMP.
• Conduct CGMP audits and address compliance deficiencies.

Skills

Investigative skills

Customer focus

CGMP compliance

Organizational skills

Analytical skills

Problem-solving skills

Decision-making skills

Communication skills

Interpersonal skills

Teamwork

Knowledge of CGMP regulations

Strategic working

Regulatory interaction experience

GMP background

Industrial manufacturing knowledge

Education

Master’s Degree in Science

Bachelor’s Degree in Science

Tools

MS Office Applications

Job description

A major IT staffing company is seeking a Quality Compliance Investigator to manage and lead investigations into GMP operations. The candidate will support internal and external audits, ensure compliance with CGMP standards, and track corrective actions effectively. With a strong focus on compliance and organization, the ideal applicant must possess exceptional analytical, communication, and interpersonal skills, along with a solid background in quality and biopharmaceutical experience. This role is crucial for maintaining stringent quality requirements in the fast-paced pharmaceutical environment.