Associate Director, Pharmacovigilance Quality & Compliance (PVQA)
Burlington, MA
Full Time
Medical
Experienced
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 PharmaEssentia USA. Join us, and let’s transform lives, together.
PharmaEssentia 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 Exchange (6446) and 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 PharmaEssentia. 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:
Qualifications:
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
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 PharmaEssentia USA. Join us, and let’s transform lives, together.
PharmaEssentia 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 Exchange (6446) and 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 PharmaEssentia. 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.
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 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.
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following 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
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.
PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
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