BioMarin Pharmaceutical Inc.
Director, GVP Compliance
BioMarin Pharmaceutical Inc., San Rafael, California, United States, 94911
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.
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
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 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
EQUIPMENT 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.
The salary range for this position is: $176,000 to $242,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://careers.biomarin.com/benefits.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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.
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
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 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
EQUIPMENT 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.
The salary range for this position is: $176,000 to $242,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock‑based long‑term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company‑sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://careers.biomarin.com/benefits.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
#J-18808-Ljbffr