Overview
Quality Assurance Program Manager Jobs in Saint Petersburg, FL at OneBlood
At Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Senior Director, R&D Quality the Director/Associate Director, R&D Quality PV will collaborate closely with cross-functional teams, including PV, Regulatory Affairs, Clinical, and Legal. The Quality Assurance AD/Director overseeing Pharmacovigilance (PV) and Safety, as well as clinical trial oversight is a critical leadership role responsible for ensuring operational quality and compliance with global regulatory requirements, industry standards, and company policies. This role involves designing, implementing, and managing quality systems and processes to support drug safety, pharmacovigilance and clinical trial oversight activities, ensuring subject safety, and maintaining the highest quality standards across the organization.
This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to):
Develops and executes a comprehensive and efficient Quality Assurance strategy for Pharmacovigilance and Safety activities, aligning with Viridian goals and regulatory requirements
Provides expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) global regulatory expectations (FDA, EMA, ICH), and industry best practices to ensure compliance and operational excellence
Represents the R&D QA function in leadership forums, audits, and regulatory inspections related to PV, Safety, and clinical trial activities
Together with Quality Systems, establishes and maintains a robust quality management system (QMS) for PV processes, including SOPs and training
Monitors deviation discovery and management, tracks CAPA implementation, and evaluates effectiveness
Oversees the development and maintenance of PV agreements and ensures compliance with partner/vendor contracts
Reviews processes for data integrity and quality during signal detection and risk management activities
Ensures validation and control of PV Database(s)
Ensures PV outputs are compliant including individual case safety reports (ICSR), development safety update report (DSUR), Risk Management Plan (RMP), etc.)
Identifies, tracks, trends, and communicates PV compliance activities to senior management
Plans, conducts, and oversees audits and inspections of R&D processes, systems, and vendors, including PV, to assess compliance and identify areas for improvement
Addresses audit and inspection findings by developing and implementing effective remediation plans
Establishes processes to identify, assess, and mitigate risks related to pharmacovigilance and drug safety activities
Drives continuous improvement initiatives to enhance the efficiency, effectiveness, and compliance of PV quality systems
Interacts with clinical vendors to ensure compliance with GCPs and relevant country regulations
Partners with PV, Safety, Regulatory, and Clinical teams to ensure alignment on quality standards and compliance requirements
Develops and delivers targeted training programs on GVP, regulatory expectations, and quality principles for Viridian teams
Qualifications:
7+ years of experience in Quality Assurance, Pharmacovigilance, or a related field within the pharmaceutical, biotechnology, or healthcare industries
Bachelor’s degree in Life Sciences of related discipline is required
Proven experience in leading GVP audits, regulatory inspections, and quality management systems
Deep understanding of GVP, ICH guidelines, FDA, EMA, MHRA, and other global regulatory requirements for pharmacovigilance
Familiarity with PV databases, signal detection processes, and safety risk management
Strong analytical, problem-solving, communication, and decision-making skills
Works effectively in a team environment
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
Fertility and mental health programs
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various mental, financial, and proactive physical health programs covered by Viridian
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
Title: Quality Assurance Program Manager
Company: OneBlood
Location: Saint Petersburg, FL
