Associate Director, Pharmacovigilance Quality & Compliance; PVQA

Position: Associate Director, Pharmacovigilance Quality & Compliance (PVQA)
The Company:

It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at Pharma Essentia USA. Join us, and let’s transform lives, together.

Pharma Essentia USA Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking.

Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchangeand are expanding our global presence with operations in the U.S., Japan, and China, along with a world‑class biologics production facility in Taichung.

Position Overview:

The Pharmacovigilance (PV) Quality and Compliance Associate Director will be responsible for ensuring Pharmacovigilance activities adhere to global regulatory standards and quality expectations across all safety activities. This role oversees the development and maintenance of the PV Quality Management System (QMS), manages audits and inspections, and drives continuous process improvement to enhance compliance and efficiency. Acting as a key liaison between internal teams and external vendors, the PV Quality and Compliance Associate Director provides expert guidance on SOPs, CAPAs, and inspection readiness, while monitoring risks and quality metrics with our CRO’s and within pharmacovigilance for Pharma Essentia.

The ideal candidate brings deep knowledge of global PV regulations, strong leadership, and the ability to foster collaboration across functions to uphold the highest standards of patient safety and regulatory compliance.

Key Responsibilities:

• Pharmacovigilance Quality Oversight & Compliance:
- Lead the development and maintenance of the PV Quality Management System (QMS).
- Ensure compliance with global regulatory requirements (FDA, EMA, MHRA) and ICH-GCP/ICH-E2E guidelines.
- Oversee PV audits, inspections, and readiness activities with PV vendors.
- Collaborate with CRO vendor, QA, Regulatory, and Clinical teams to implement corrective and preventive actions (CAPAs).

• Process & SOP Management:
- Develop, review, and approve Standard Operating Procedures (SOPs) and work instructions for PV activities.
- Build/maintain an inspection readiness program to detect potential gaps and monitor CPA Effectiveness.
- Ensure process standardization across global PV operations.
- Drive continuous improvement initiatives to enhance efficiency and compliance with vendors and internally.
- Ensure high quality ICSR on time management
- Track and interpret changes in regulations within Pharmacovigilance landscape
- Works with responsible person/team to author a required regulatory response.

• Risk Management & Oversight:
- Monitor key quality and compliance metrics, identify risks, and recommend mitigation strategies.
- Conduct internal and external vendor quality reviews and gap assessments r/t safety.
- Support global safety reporting quality oversight.

• Leadership &

Collaboration:

- Provide guidance and training to PV staff on quality standards and compliance expectations.
- Serve as a subject matter expert for inspections, regulatory audits, and PV compliance matters.
- Cross functional collaboration with Call center, supply chain, Manufacturing (QA) and US QA teams to oversee any quality issues that may arise that involve PSRM
- Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-quality safety processes.

Required Education/

Experience and Skills:

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

• Minimum 8–10 years of experience in pharmacovigilance, with at least 3–5 years in PV quality and compliance.

• Strong knowledge of global PV…