Director, GVP Compliance
BioMarin Pharmaceutical, Washington, District of Columbia, United States
GVP Compliance Lead
BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance. This important role will be joining our Global Quality organization and reports into the Head of R&D Compliance. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GVP Compliance Lead partners with the GCP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program. This individual is also a key point of contact supporting the planning and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues. BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess. Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure patient safety in pharmaceutical practices through a comprehensive strategy that integrates regulatory compliance, risk management, pharmacovigilance, and continuous improvement. Responsibilities include championing the implementation of Global Quality vision, policies, processes, and decisions; collaborating with stakeholders to identify, communicate, and mitigate compliance risks; continually enhancing partnerships with key stakeholders and leaders across the business; supporting and driving the implementation of quality and compliance projects and objectives; staying updated on regulations and recommending proactive compliance changes when necessary; developing and enhancing GVP Compliance processes and best practices; leading the execution of the GVP Compliance Global Audit Program; acting as a GVP compliance core team member on regulatory inspection teams and supporting mock readiness activities; providing insights to continually optimize the GVP Compliance Audit Program; contributing to Pharmacovigilance System Master File (PSMF) updates; being a core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program; creating a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect; mentoring and developing staff to achieve their full potential; conducting management activities, including staffing, budget monitoring, and strategic planning; and managing recruiting, hiring, and evaluations with HR and Global Quality leadership. Required skills include 10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance; working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations; experience working in Pharmacovigilance (PV) within Quality and Compliance; experience executing or managing Health Authority Inspections; experience executing or managing R&D Audits and GVP Audit Program; experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants; experience navigating and understanding a quality management system; core leadership competencies in strategic thinking, agility, prioritization, communication and decision making; experience in managing staff and leading teams; strong verbal, written and oral communication skills. Able to present to Senior Leadership. Able to work independently and be flexible to rapidly changing priorities; and strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems. Desired skills include experience with Business Development partnerships, mergers and/or acquisitions; exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines; awareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing; and compliance oversight of REMS Program(s). Education: Bachelor's Degree within a life science focus area, master's degree is a plus. Supervisor responsibility includes (3) direct reports: Associate Director, GVP Compliance; Senior Manager, GVP Compliance; Manager, GxP Compliance. Shift details include an 8-hour per day shift. If EU employee identified, shifts include at least (2) days per week with required partial overlap with the US EST and PST hours of operation. This role has the flexibility to be a remote position, covering both EU and US time zones. There is no requirement to be strictly onsite, however, staff local to the SRC and Novato offices will be expected to be onsite following the hybrid role requirements. May travel up to 10-20% of the time. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance. This important role will be joining our Global Quality organization and reports into the Head of R&D Compliance. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GVP Compliance Lead partners with the GCP and GLP Compliance leads to ensure oversight and timely execution of the BioMarin R&D Audit Program. This individual is also a key point of contact supporting the planning and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues. BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess. Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure patient safety in pharmaceutical practices through a comprehensive strategy that integrates regulatory compliance, risk management, pharmacovigilance, and continuous improvement. Responsibilities include championing the implementation of Global Quality vision, policies, processes, and decisions; collaborating with stakeholders to identify, communicate, and mitigate compliance risks; continually enhancing partnerships with key stakeholders and leaders across the business; supporting and driving the implementation of quality and compliance projects and objectives; staying updated on regulations and recommending proactive compliance changes when necessary; developing and enhancing GVP Compliance processes and best practices; leading the execution of the GVP Compliance Global Audit Program; acting as a GVP compliance core team member on regulatory inspection teams and supporting mock readiness activities; providing insights to continually optimize the GVP Compliance Audit Program; contributing to Pharmacovigilance System Master File (PSMF) updates; being a core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program; creating a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect; mentoring and developing staff to achieve their full potential; conducting management activities, including staffing, budget monitoring, and strategic planning; and managing recruiting, hiring, and evaluations with HR and Global Quality leadership. Required skills include 10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance; working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations; experience working in Pharmacovigilance (PV) within Quality and Compliance; experience executing or managing Health Authority Inspections; experience executing or managing R&D Audits and GVP Audit Program; experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants; experience navigating and understanding a quality management system; core leadership competencies in strategic thinking, agility, prioritization, communication and decision making; experience in managing staff and leading teams; strong verbal, written and oral communication skills. Able to present to Senior Leadership. Able to work independently and be flexible to rapidly changing priorities; and strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems. Desired skills include experience with Business Development partnerships, mergers and/or acquisitions; exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines; awareness and understanding of core PV responsibilities i.e., risk management, risk minimization measures, signal management, and case processing; and compliance oversight of REMS Program(s). Education: Bachelor's Degree within a life science focus area, master's degree is a plus. Supervisor responsibility includes (3) direct reports: Associate Director, GVP Compliance; Senior Manager, GVP Compliance; Manager, GxP Compliance. Shift details include an 8-hour per day shift. If EU employee identified, shifts include at least (2) days per week with required partial overlap with the US EST and PST hours of operation. This role has the flexibility to be a remote position, covering both EU and US time zones. There is no requirement to be strictly onsite, however, staff local to the SRC and Novato offices will be expected to be onsite following the hybrid role requirements. May travel up to 10-20% of the time. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.