Quality Assurance, Pharmacovigilance (PV) Director

Summary

Join SpringWorks Therapeutics as the Director of Quality Assurance, Pharmacovigilance (PV), and partner with the Pharmacovigilance team to ensure quality and compliance in all aspects of product safety. This instrumental role uses a risk-based approach to align PV activities with regulations and company standards. Responsibilities include identifying and resolving risks, escalating issues appropriately, and demonstrating independent quality judgment. The position requires a relevant scientific degree and significant experience in QA oversight of PV activities. Expert knowledge of ICH and health authority requirements is essential, along with strong communication and leadership skills. The role offers a hybrid or remote work option and a competitive salary and benefits package.

Requirements

• Bachelor’s degree in a relevant scientific discipline in a related discipline and 9 years of related experience, or Master's degree in a related discipline and 7 years of related experience, or PhD in a related discipline and 4 years of related experience
• Demonstrated ability to provide QA oversight of PV activities and ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP)
• Possesses expert knowledge of current ICH and health authority requirements, expectations, and trends in patient safety and pharmacovigilance
• Excellent verbal, written, and presentation communication skills, ability to work with cross-functional teams and prioritize work, manage multiple projects while maintaining quality and advocating compliance
• Demonstrated knowledge and thorough understanding of GVP in accordance with US/MHRA/EU/ROW Health Authority regulations, and industry standards such as ICH for the pharmaceutical industry
• Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
• Ability to deal with ambiguity and provide creative and pragmatic solutions to issues and risks
• Strong understanding of clinical development, post-marketing safety, and regulatory submissions
• Experience interacting with global regulatory authorities and scientific advisory bodies
• Exceptional leadership, strategic thinking, and communication skills
• Solid computer/analytical skills
• Proficient in Microsoft Word, Excel, and PowerPoint
• Working knowledge of Veeva Vault platform, experience in CAPA and risk management software
• Excellent team player, strong collaborator and able to matrix-manage teams effectively
• Ability to coach and mentor staff
• Able to interact and liaise effectively with people at all levels of the organization and with external collaborators, vendors and health authority representatives
• Excellent written and verbal communication skills
• Thorough understanding of industry standards (e.g., regulatory, quality, technology)
• Deep understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), monitoring, vendor management/oversight, data management, statistical analysis, clinical study reports, and regulatory submissions
• Independently motivated, detail-oriented, with strong organizational skills
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams’ performance
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment
• Ability to travel occasionally including overnight stay driven by business need, may require up to 20% travel
• This position must be able to work East Coast hours

Responsibilities

• Establish and maintain a compliant QA oversight program for PV and ensure compliance with reporting standards and company policies
• Provide Quality Assurance leadership and Subject Matter Expertise (SME) for Good Pharmacovigilance Practices (GVP) to pharmacovigilance teams
• Provide QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment
• Drive a risk-based approach to creating and maintaining the PV audit program
• Oversee the QMS with appropriate metrics and trending
• Support inspection readiness activities including audits and inspections conducted by external sources as applicable
• Partner with the PV Operational team to problem solve and strategize
• Author and maintain QA PV Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Provide Quality oversight for PV related documents, including SOPs and WIs
• Provide Quality oversight for PV deviation and CAPA program
• Lead process improvement projects as needed
• Stay current with new and revised regulations and trends in industry standards
• Perform other duties and responsibilities as assigned

Benefits

• The expected salary range for this position is $170,000 – $220,000
• Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law
• A discretionary annual bonus may be available based on individual and Company performance
• We offer best-in-class benefits for our team of SpringWorkers who work with urgency on behalf of patients suffering from devastating diseases