Associate Director, Pharmacovigilance Quality & Compliance

Job not on LinkedIn

November 8

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $150k - $200k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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PharmaEssentia

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Biotechnology • Pharmaceuticals • Healthcare Insurance

PharmaEssentia is a biotechnology company focused on the development, manufacture, and commercialization of treatments for chronic conditions such as blood disorders and cancers. The company leverages its expertise in biotechnology to bring innovative therapies to patients worldwide, with a strong commitment to improving patient outcomes.

201 - 500 employees

Founded 2003

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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). • Develop, review, and approve Standard Operating Procedures (SOPs) and work instructions for PV activities. • Monitor key quality and compliance metrics, identify risks, and recommend mitigation strategies. • Provide guidance and training to PV staff on quality standards and compliance expectations. • Collaborate with cross-functional teams (Clinical, Regulatory, Medical Affairs, and Operations) to maintain high-quality safety processes.

🎯 Requirements

• 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 regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP). • Proven experience leading PV audits and inspections. • Demonstrated ability to develop and implement quality management systems and SOPs. • Excellent leadership, communication, and problem-solving skills. • Ability to influence cross-functional teams and drive compliance initiatives.

🏖️ Benefits

• Comprehensive medical coverage • Dental and vision coverage • Generous paid time-off • 401(k) retirement plan with competitive company match • Medical & Dependent Care Flexible Spending Account • Up to $150 monthly cell phone reimbursement • Employee Assistance Program • Free parking