Associate Director, GCP Compliance

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.

Summary BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare diseases. To support this important mission, we are looking for an individual with experience working in GCP Compliance within R&D Compliance. This important role will join the BioMarin Global Quality organization.  This role advises internal and external key stakeholders on Good Clinical Practices (GCP) matters and assesses compliance with international regulations/guidelines, corporate policies, and standard operating procedures. This individual is a key point of contact supporting regulatory inspections for assigned products 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, and strategic thinking are important skills the candidate would possess.  Prior experience as an auditor or desire to develop into a GCP auditor would be an additional area of expertise desired.   All employees are required to follow defined processes and policies and behave in a professional manner with integrity. Responsibilities This Associate Director Level role will be a core team member of GCP Compliance and responsible for the following:
Primary Responsibilities    Act as a subject matter expert by providing GCP compliance advice to the assigned clinical program(s), including training and updates for applicable regulations
    Influence decision makers and utilize sound problem-solving skills to recommend options for implementation of compliant and effective solutions
    Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to BioMarin policies and practices to maintain proactive compliance
    Provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans
    Support audit program management in defining audit scope, conducting audits, generating audit reports, assisting auditees with development of CAPA Plans, evaluating post audit finding responses and reviewing evidence to ensure on-time closure of audit records in the eQMS
    Act as a GCP compliance core team member on regulatory inspection team(s) and participate in the development and review/approval of GCP regulatory commitments following inspection
    Participate in due diligence activities and process improvement initiatives, as requested
    Provide quality reviews of protocols, amendments, and other study-specific documents as requested for consistency and acceptable standards and practices to ensure compliance with internal standards, regulations, and ICH GCP guidelines EducationBachelor’s Degree within a life science focus areaExperience/Abilities    Working knowledge of FDA Regulations, EMA and application of Good Clinical Practices (GCP), and/or ICH, and relevant guidelines
    10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance or extensive clinical operations experience associated with monitoring of clinical sites and managing clinical studies
    Ideal candidate will have exposure to working in any phase of pharmaceutical drug development or post-marketing surveillance of medicines
    Strong verbal, written and oral communication skills.  Able to present to Senior Management
    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 Work Environment/Physical DemandsMay travel up to 20% of the time.
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 o