GCP Compliance Lead

BioMarin Pharmaceutical Inc.

4d•Remote

About The Position

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 Clinical Development 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 is responsible for establishing, maintaining, and continuously improving the organization’s Good Clinical Practice (GCP) compliance framework to ensure subject safety, data integrity, and enforcing ethical principles across the clinical lifecycle. As an advisor, the GCP Compliance Lead supports the internal and external key stakeholders on Good Clinical Practices (GCP) matters and leads a team who collectively assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. The GCP Compliance Lead partners with our GVP 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 GCP 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 clinical trial subject safety and data integrity through a comprehensive strategy that integrates GCP regulatory compliance, risk-based oversight, issue management, and continuous improvement.

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, PMDA and global PV Regulations, and application of Good Clinical Practices (GCP), ICH and GCP regulations
Experience working in Clinical Development within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GCP Audit Program
Experience with identifying optimal strategy for executing a GCP 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

Nice To Haves

Experience with Business Development partnerships, mergers and/or acquisitions
Management and Oversight of Computer System Validation (CSV) / Data Integrity (CSDI) Audit
Exposure to working in any phase of pharmaceutical drug development
Awareness and understanding of core clinical responsibilities i.e., study start-up, protocol design, quality risk management, trial conduct, monitoring, data management, Trial Master File (eTMF), etc.

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 as a trusted advisor 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 GCP Compliance processes and best practices
Maintain BioMarin processes to ensure evaluation & escalation of serious non-compliance
Lead the execution of the GCP Compliance Global Audit Program
Act as a GCP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GCP Compliance Audit Program
Create a high-functioning team to ensure GCP 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