Regulatory Compliance & Quality Assurance Lead

Mentor Technical Group; San Juan (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Mentor Technical Group seeks a qualified regulatory affairs professional to lead QA activities, audits, and CAPA development. You will ensure adherence to FDA CFRs, DEA, and pharmacopeia standards across projects and coordinate cross‑department efforts to sustain regulatory compliance.

The role emphasizes audit management, process improvements, and training to keep teams aligned with evolving regulations and client requirements.

Qualifikationen

• Bachelor’s degree in chemistry, microbiology, engineering or related STEM field.
• 3–5 years in QA or regulatory affairs within a regulated industry.
• Knowledge of FDA CFRs, DEA, and Pharmacopeia standards.
• Experience with LIMS and QMS systems (TrackWise, TruVault).
• Audits and responses to audit findings experience.
• Strong regulatory knowledge and analytical/problem-solving skills.
• Excellent communication and leadership for client meetings and cross-department collaboration.
• Experience with validation protocols is a plus.

Aufgaben

• Lead audits and manage CAPAs to address root causes.
• Develop, implement and maintain compliance programs and SOPs.
• Conduct regular audits, inspections and risk assessments.
• Guide cross‑functional teams on compliance issues and corrective actions.
• Stay updated on regulations and drive continuous quality improvements.
• Lead staff training on regulatory changes and QA best practices.
• Maintain system for tracking overall compliance with client requirements.
• Evaluate deviations and determine regulatory impact with reports.
• Oversee regulatory aspects including audits, investigations, and CAPAs.
• Support RCA, HPA and process mapping meetings to resolve major deviations.
• Assist in creation, review and training for Validation Qualifications and Protocols.
• Ensure compliance with international, federal and local regulations and client requirements.

Kenntnisse

Quality assurance

Regulatory affairs

Audits

Root cause analysis

CAPA

Cross-functional leadership

Training

Ausbildung

Bachelor’s degree in chemistry, microbiology, engineering or related STEM

Tools

LIMS

TrackWise

TruVault

Jobbeschreibung

Mentor Technical Group seeks a qualified regulatory affairs professional to lead QA activities, audits, and CAPA development. You will ensure adherence to FDA CFRs, DEA, and pharmacopeia standards across projects and coordinate cross‑department efforts to sustain regulatory compliance.

The role emphasizes audit management, process improvements, and training to keep teams aligned with evolving regulations and client requirements.