Stability QC Leader: Drive Compliance & Quality Impact

Regulatory Jobs; Vega Baja (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Viatris Pharmaceuticals LLC is seeking a Manager/Team Lead for Quality Control Stability to oversee the stability analytical laboratory, ensuring cGMP and GLP compliance. The role involves directing QC staff, implementing quality systems, and supporting regulatory inspections to maintain product quality and regulatory readiness.

The candidate will review procedures, manage data integrity, and collaborate with development teams to ensure accurate stability assessments of APIs and finished

Qualifications

• Bachelor’s degree in science with concentration in Chemistry is required.
• Minimum 10 years in pharmaceutical laboratory experience; 5+ years in a supervisory role.
• Experience in analytical testing QC laboratory and regulatory compliance.
• Knowledge of cGMP, FDA, DEA, EMA, OSHA, and related regulations.
• Strong leadership and ability to guide TLs/Supervisors and staff.

Responsibilities

• Develops and maintains a stability QC organization.
• Ensures SOPs and procedures align with regulations and company policies.
• Reviews/approves specifications for finished materials, raw materials, and packaging.
• Supports regulatory inspections and quality management system improvements.
• Provides guidance during investigations of questionable results or out-of-spec outcomes.
• Ensures data integrity and proper documentation within the QC Stability Laboratory.
• Collaborates with development teams on stability testing and regulatory requirements.

Skills

Quality Control Leadership

Regulatory compliance

cGMP knowledge

Analytical testing

Supervisory experience

Education

Bachelor’s degree in science - Chemistry

Master’s degree desirable

Tools

Analytical equipment knowledge

Job description

Viatris Pharmaceuticals LLC is seeking a Manager/Team Lead for Quality Control Stability to oversee the stability analytical laboratory, ensuring cGMP and GLP compliance. The role involves directing QC staff, implementing quality systems, and supporting regulatory inspections to maintain product quality and regulatory readiness.

The candidate will review procedures, manage data integrity, and collaborate with development teams to ensure accurate stability assessments of APIs and finished