GCP Compliance Lead

Location:  remote, United States Category: Quality

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Description

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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 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.
 
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
 
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, 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
 
Desired Skills:
 
  • 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.
 
EDUCATION
 
Bachelor’s Degree within a life science focus area, master’s degree is a plus 
 
ONSITE, REMOTE, OR FLEXIBLE 
 
This role has the flexibility to be a remote position, covering 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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