Director, GVP Compliance

Location:  remote, United States Category: Quality

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Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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 and coordinating the worldwide movement of our drugs to patients.

TITLE
GVP Compliance Lead
 
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 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 
 
  • Championing the implementation of 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
  • Develop and enhance GVP Compliance processes and best practices
  • Lead the execution of the GVP Compliance Global 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
  • Core team member and key contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program
  • Create a high-functioning team to ensure GVP compliance and foster a culture of teamwork and mutual respect
  • Mentor and develop staff to achieve their full potential
  • Conduct management activities, including staffing, budget monitoring, and strategic planning
  • Manage recruiting, hiring, and evaluations with HR and Global Quality leadership
 
EXPERIENCE
 
Required Skills:
 
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
  • Strong computer skills including working within the MS Suite of tools, and interfacing with Quality Management Systems
 
Desired Skills:
 
  • 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
  • Compliance oversight of REMS Program(s)
 
EDUCATION
 
Bachelor’s Degree within a life science focus area, master’s degree is a plus 
 
 
Quality Management System (eQMS) 
 
CONTACTS 
 
Head of R&D Quality
GCP Compliance Lead
GLP Compliance Lead
Head of Global PV Operations
Regulatory Affairs
Commercial Operations
 
SUPERVISOR RESPONSIBILITY 
 
(3) direct reports:
  • Associate Director, GVP Compliance
  • Senior Manager, GVP Compliance
  • Manager, GxP Compliance
 
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 and Novato offices will be expected to be onsite following the hybrid role requirements.
 
TRAVEL REQUIRED 
 
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.



Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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