Director, GVP StrategyLocation Apply
Director, GVP Strategy
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care and providing personalized support and services globally.
The BioMarin GxP Compliance function is tasked with providing independent assurance services designed to enhance scientific innovation with effective risk management. The GxP Compliance team partners with the business to strengthen the commitment to compliance by advising cross-functional teams through the Strategy subfunction, identifying and mitigating risk through the Audit subfunction, and leading distribution and proactive compliance through the Operations subfunction.
Within GxP Compliance, the Strategy subfunction serves to provide advising on elements of GxP Compliance to cross-functional Product, Program, and/or Study Teams, monitoring and providing compliance expertise through the program lifecycle, and supporting regulatory submissions. The GxP Strategy subfunction also provides compliance guidance on GxP topics and provides insight to the audit team to inform audit approaches.
As the GVP Compliance Strategy Group Head, the Associate Director/Director is responsible for team management and oversight of all GVP Compliance activities and the development, execution, and management of the Good Pharmacovigilance Practices (GVP) Compliance program at BioMarin. This role advises internal and external key stakeholders on the compliance impact of pharmacovigilance (PV) 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.
Team leadership, management, and operations
- Collaborate with leaders of GxP Strategy, Audit, and Operations groups to set strategy and business objectives and contribute to vision, policies, processes, and strategic and operational decisions
- Lead or participate in Compliance operational and corporate projects
- Create a cohesive, balanced, and high-functioning team focused on driving continuous improvement
- Foster a culture of teamwork, collaboration, and respect, and promote professional growth
- Aid in developing staff to achieve their full potential and execute project deliverables against goals and timeline
- Conduct management activities, including staffing, budgeting, strategic planning, and communication
- Manage recruiting, hiring, and evaluations in collaboration with HR and GxP Strategy Functional Head for managed staff
- Mentor and guide managed staff on BioMarin career development
GVP Strategy Oversight
- Oversee management of the overall GVP strategy program, including all processes and systems
- Continuously improve the GVP Strategy sub-function at BioMarin
- Plan and coordinate regulatory inspection activities with GxP Strategy leadership team
- Collaborate on audit activities with GxP Audit leadership team
- Act as escalation point, supporting the team on the identification and resolution of issues, risk management, and inspection-related risks
- Report on overall status of GVP compliance and regulatory inspection-related activities to leadership team
- Contribute to the quarterly Board of Director Compliance updates; ensure report and presentation are to a high standard
- Stay abreast of new regulations and coach stakeholders and team members
Compliance strategy and execution
- Liaise with all program/product leads from GxP Strategy organizations to maintain a comprehensive view of the program’s compliance status
- Assure the integrity and quality of drug safety information by supporting and advising on domestic and international internal and external audits, including PV and REMS partners, vendors, affiliate offices, and internal departments/systems
- Collaborate with stakeholders on quality review of PV and REMS documents, including SOPs, Pharmacovigilance Site Master File (PSMF) audit content, and REMS material; for PSMF content, provide routine updates and ensure on-demand readiness and compliance with the legal requirements in the EU/EEA
- Define and track key process indicators (KPIs). Facilitate the Management Metrics Review (MMR) for GPV programs
- Work with internal and client group leaders 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
- Provide assistance or guidance to the responsible parties in developing and completing corrective and preventive action plans
- Assist with tracking GVP Compliance audit trends and group metrics
- Act as the GVP compliance lead on regulatory inspection readiness teams. Participate as a core member on the regulatory inspection team, provide leadership and manage GVP regulatory inspections globally, and oversee the development and tracking of GVP regulatory commitments
- Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to BioMarin policies and practices to maintain proactive compliance
- Maintain expert level knowledge of compliance requirements and industry trends, including relevant modalities such as gene therapy, small molecule applications, and enzyme replacement therapies (ERTs)
- Participate in the development and/or enhancement of GVP Strategy and corporate GVP/GxP Compliance business processes, procedures, and best practices
- Act as a subject matter expert by providing GxP Compliance advice and counsel to internal stakeholders, including training and updates for applicable regulations and guidelines
- Inform stakeholders regarding compliance trends and changes
- Participate in the development and/or enhancement of corporate GxP Compliance processes, procedures, and best practices
- Actively represent the Compliance organization in applicable forums and provide update
- Provide input to the Audit team on risk-based audit planning/scheduling and appropriateness of corrective actions for audits of internal and external PV entities
- Represent Compliance during issue management and escalation scenarios. Communicate critical information regarding significant quality or patient safety risk to senior/executive management and key stakeholders
The Associate Director/Director may lead or manage a function or department. This position will have an impact on functional area strategy and operations.
This role may manage multiple direct reports.
CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
- Recognized as an innovative problem solver
- Encourages and coaches teams and functional areas to leverage data and think critically and thoroughly about solutions and their implications
- Leverages nuanced understanding of the nature and implications of BioMarin matrix organizational structure to find information, including through creative and non-traditional avenues when necessary
- Identifies and leverages common goals and incentives to inspire teams/stakeholders to achieve optimal outcomes
- Inspires, motivates and empowers employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
- Creates an inclusive, collaborative environment for teams and meetings that promotes co-creation, open dialogue, and decision making, encouraging all team members to express ideas and concerns constructively
- Actively models and encourages open, honest, and clear communication across teams and functions; establishes a team/functional culture of delivering and receiving constructive feedback
- Exceptional meeting facilitator, takes initiative to promote effective decision making and mutual understanding among cross-functional and/or executive level participants
- Develops and communicates short- and long-term priorities through an assessment of future trends and current strategy
- Subject matter expert in both the understanding and interpretation of global regulations and guidance for GvP
- Accurately assesses key areas of risk in the GxP area and proactively develops appropriate actions to mitigate risk areas
- Comprehensive understanding of the dependencies between risk management and strategic objectives
- BA/BS degree (advanced degree preferred) with a focus on life sciences or a related scientific or technical discipline
- 12+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS; 10+ years with MA/MS
- 3 or more years of people management experience
Computer work utilizing common business software programs and hardware solutions.
This position will interact with a range of personnel across the organization, including but not limited to other Compliance personnel and staff in Pharmacovigilance, Regulatory, Clinical Operations, Medical Affairs, and others.
*May travel up to 25% 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.