Associate Director, GVP Compliance in London

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia, PKU, CLN2, and various forms of MPS offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing.

SUMMARY

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 GVP Compliance Lead. This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures.

RESPONSIBILITIES

• Advancing the execution of the Global Quality vision, policies, processes, and decisions
• Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
• Continually enhance partnerships with key stakeholders and leaders across the business
• Support and drive the implementation of quality and compliance projects and objectives
• Stay updated on regulations and recommend proactive compliance changes when necessary
• Execute against GVP Compliance processes and best practices
• Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program
• Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
• Provide insights to continually optimize the GVP Compliance Audit Program
• Contribute to Pharmacovigilance System Master File (PSMF) updates
• Contribute to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
• Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect
• Mentor and support the development of junior staff to achieve their full potential

EXPERIENCE

• 8+ years of experience working within a regulated healthcare industry including a role in the 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 competencies in strategic thinking, agility, prioritization, communication and decision making
• Strong verbal, written and oral communication skills. Able to present to Senior Leadership.
• Able to work independently and be flexible to rapidly changing priorities
• Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems

EDUCATION

• Bachelor’s Degree within a life science focus area, master’s degree is a plus

SHIFT DETAILS

Shift will be 8 hours per day. 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.

ONSITE, REMOTE, OR FLEXIBLE

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, Shanbally, Dublin, London and Novato offices will be expected to be onsite following the hybrid role requirements.

TRAVEL REQUIRED

May travel up to 25%+ of the time.