PV Quality & Compliance Leader (Operational Excellence)

Viridian Therapeutics, Inc.; Waltham (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, vision insurance

Disability coverage (short/long-term)

401(k) Company Match

Employee Stock Purchase plan

Generous vacation and holidays

Job summary

Viridian Therapeutics, Inc. is seeking a Director of PV Operational Excellence to provide quality oversight across the pharmacovigilance lifecycle at its Waltham, MA headquarters.

This leader will partner with senior PV and QA teams to ensure regulatory compliance, CAPA management, and inspection readiness. The role requires 12+ years in PV, a relevant advanced degree, and proven experience with safety databases and regulatory guidelines.

Qualifications

• 12+ years pharmacovigilance experience.
• Advanced degree preferred (PharmD/MD/PhD).
• Experience with regulatory guidelines FDA/EMA/ICH.
• Vendor management oversight responsibilities.
• Development and review of SOPs and Work Instructions.

Responsibilities

• Define and implement PV quality programs for global compliance.
• Lead PV quality issues and CAPAs processes.
• Support late case investigations process.
• Develop and communicate PV quality indicators.
• Ensure cross-functional PV system compliance.
• Lead inspection readiness activities.
• Oversee PV regulatory intelligence activities with QA.
• Collaborate with QA on training for Pharmacovigilance.
• Provide strategic direction and global oversight of PV quality initiatives.
• Oversee outsourced hosted safety databases with IT.

Skills

Leadership

Communication

Analytical thinking

Organizational skills

Travel readiness

Integrity

Ethical standards

Adaptability

Education

Advanced degree (PharmD/MD/PhD)

Tools

MedDRA

WHO Drug Dictionary

Argus

ArisG

Veeva Safety

Job description

Viridian Therapeutics, Inc. is seeking a Director of PV Operational Excellence to provide quality oversight across the pharmacovigilance lifecycle at its Waltham, MA headquarters.

This leader will partner with senior PV and QA teams to ensure regulatory compliance, CAPA management, and inspection readiness. The role requires 12+ years in PV, a relevant advanced degree, and proven experience with safety databases and regulatory guidelines.