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Associate Director, GxP Compliance

3 months ago

San Rafael, California, United States BioMarin Pharmaceutical Inc. Full time

Who We Are

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.

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 R&D Quality and Compliance, or PV/drug safety quality operations. This important role will join our Worldwide Research and Development (WWRD) Quality Compliance team within the BioMarin Quality organization.

This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) 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 PV 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.

This Associate Director Level role will be a core team member of GVP Compliance and responsible for the following:

Primary Responsibilities
 Work with stakeholders across the business to proactively identify, communicate/escalate, and mitigate material compliance risk
 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
 Participate in the development and/or enhancement of GVP Compliance business processes, procedures, and best practices
 Support audit program management in defining audit scope, conducting audits (when applicable), reviewing 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 GVP compliance core team member on regulatory inspection team(s) and participate in the development and review/approval of GVP regulatory commitments following inspection
 Participate in due diligence activities and process improvement initiatives, as requested
 Participate in regular Pharmacovigilance System Master File (PSMF) updates to support audit and CAPA status reportingEducationBachelor's Degree within a life science focus area Experience/Abilities Working knowledge of FDA Regulations, EMA and application of Good Pharmacovigilance Practices (GVP), and/or ICH, or GCP regulations
 10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
 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. Role requires candidate to be onsite in San Rafael, CA for a minimum of 2 days per week.
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.