Quality Assurance, Pharmacovigilance (PV) Director

About SpringWorks Therapeutics: SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. Your Role: The primary responsibility for the role of Director of Quality Assurance, Pharmacovigilance (PV) is partnering with the Pharmacovigilance team to assure their strategy and execution ingrains quality and compliance across all aspects of product safety during clinical development and post-marketing surveillance. This role is instrumental in applying a risk-based approach to ensure that PV activities align with regulatory requirements and company standards. This position is responsible for identifying risks, resolving issues, and escalating them appropriately. This leader should demonstrate an elevated level of independent quality judgement and acumen. Location Classification - Hybrid: This role will be required to work onsite 2 days a week (Tuesday and Wednesday), or more depending on business needs. #LI-Hybrid OR Location Classification - Remote: Officially classified as working full-time from employee's home office within the United States or respected region, with the expectation to travel to SpringWorks Therapeutics offices or other locations on occasion as business needs. #LI-Remote Essential Duties and 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. Role Requirements: • Education: 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.