QA Compliance Lead, Life Sciences

Inteldot; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Inteldot is seeking an Administrative Quality Assurance professional to support the site’s QA program in Puerto Rico. You will oversee quality systems, investigations, and regulatory readiness to ensure compliant manufacturing operations.

Responsibilities include leading cross-functional teams, reviewing validation activities, and guiding data-driven quality decisions. Strong documentation, project management, and knowledge of GMP are essential for success in this role.

Qualifications

• Proven QA and compliance experience in life sciences manufacturing.
• Experience with validation and regulatory documentation.
• Strong data analysis and decision-making skills.
• Experience leading investigations and cross-functional teams.
• Familiarity with regulatory inspections and audits.
• Excellent documentation practices and data integrity.

Responsibilities

• Own site-level quality activities, quality systems, and compliance assessments.
• Review and approve product MPs.
• Lead investigations, determine root causes, and ensure corrective actions.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory and Supply Chain.
• Manage project timelines, deliverables, and prioritized assignments.
• Prepare for regulatory interactions and inspections.
• Analyze data trends to support quality decisions.
• Maintain documentation and data integrity across processes.

Skills

Facilities and Utilities Commissioning

Qualification

Computer System Validation

Equipment validation

Risk Assessments

Management

Education

Doctorate + 2 years related experience

Tools

KNEAT

CDOCS

SCADA

TRACKWISE

MAXIMO

Job description

Inteldot is seeking an Administrative Quality Assurance professional to support the site’s QA program in Puerto Rico. You will oversee quality systems, investigations, and regulatory readiness to ensure compliant manufacturing operations.

Responsibilities include leading cross-functional teams, reviewing validation activities, and guiding data-driven quality decisions. Strong documentation, project management, and knowledge of GMP are essential for success in this role.