Associate 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 Lead, the Senior Manager is responsible for developing, executing, and managing the Good Pharmacovigilance Practices (GVP) Compliance program at BioMarin. This role advises internal and external key stakeholders on 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.
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 Senior Manager will be a subject matter expert and may lead or manage a team. This position will contribute to and make an impact on the department and the cross-functional process.
This position does not manage direct reports.
CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
This position requires the skills and capabilities listed below, which are based on a comprehensive competency framework outlined in the GxP Compliance career paths and competency model. Further information can be found in the GxP Compliance Career Development Handbook. Please refer to that handbook for the complete set of competency expectations and descriptions if you want to modify the below competencies for a specific job posting.
- Creates a team/working environment that encourages open dialogue and questioning of status quo, assumptions and the exploration of innovative and novel solutions
- Obtains appropriate key stakeholder and/or decision maker buy-in to any recommended solution even in contentious scenarios
- Demonstrates an understanding of organizational structure, key decision-making processes and governance and communication channels
- Demonstrates the ability to garner support from peers and positively influence outcomes, decisions, or group direction
- Inspires, motivates and empowers employees by expecting high standards of performance while giving latitude, offering encouragement, and expressing confidence
- Demonstrates an ability and eagerness to actively contribute to team efforts in a positive and constructive manner, including by taking on a leadership role within own area of work when needed
- Adapts communication style, message and delivery method and medium to audience; knows when to ask for guidance on complex or difficult messages
- Able to facilitate small and large meetings efficiently and effectively across functions, promoting collaboration, meeting stakeholder needs, and accomplishing meeting objectives
- Develops and communicates short- and long-term priorities through an assessment of future trends and current strategy
- Acts as subject matter expert in both the understanding and interpretation of global regulations and guidance
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline
- 8+ years drug safety, clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS
- One year of people management experience preferred
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.
WORK ENVIRONMENT/PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
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.