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Director, GCP Strategy

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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.

The GCP Compliance Strategy Director is a key leadership position that is responsible for the team management and oversight of all GCP Compliance activities and the development, execution and management of the Good Clinical Practices (GCP) Compliance program at BioMarin. This role advises internal and external key stakeholders on the compliance impact of GCP matters and assesses compliance with international regulations/guidelines, corporate policies, and standard operating
procedures.

RESPONSIBILITIES

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 timelines.
  • 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.
GCP Strategy Oversight
  • Oversee management of the overall GCP strategy program including all processes and systems.
  • Continuously improve the GCP 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 GCP 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
  • Act as a subject matter expert by providing GCP compliance advice to the assigned clinical program(s), including training and updates for applicable regulations.
  • 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.
  • 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.
  • Assist with tracking GCP Compliance audit trends and group metrics.
  • Act as the GCP compliance lead on regulatory inspection readiness teams. Participate as a core member on the regulatory inspection team; provide leadership during regulatory inspections and oversee the development and tracking of regulatory commitment.
  • 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 GCP Strategy and GxP
  • Compliance business processes, procedures and best practices.
Audit preparation and conduct
  • Lead or support audit activities for investigator sites.
  • Assure the integrity and quality of clinical data by independently managing, leading, participating, and following-up on audits for assigned program(s), including routine and directed, internal and external, domestic and international GCP audits.
  • Prepare and lead, or oversee, audits across multiple internal sites and third parties both domestic and international.
Cross-functional engagement
  • 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 relevant forums and provide updates.
  • Provide input to the Audit team on risk-based audit planning/scheduling, and appropriateness of corrective actions for audits of internal and external 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.
SCOPE
The Director is a leadership role within GxP Strategy. As such, the role will have significant influence on functional area strategy and operations.  May have multiple levels of reports.

CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
  • Recognized as an innovative problem solver
  • Encourage and coach teams and functional areas to leverage data and think critically and thoroughly about solutions and their implications
  • Proactively focuses on expanding network and work relationships outside department and company, building more influential, productive relationships
  • Understands the nature of the matrix organizational structure and demonstrates the can gain support from both the functional and cross-functional teams
  • Exhibits a focus on performance measurement to track progress toward objectives
  • Ensures that team roles and responsibilities are clearly defined, understood, and fulfilled
  • Works through situations involving ambiguity or setbacks by systematically evaluating options, gaining advice of colleagues (if needed), addressing competing priorities and rapidly establishing appropriate action plans with available resources.
  • Capable of crafting and effectively delivering key messaging around high visibility company-wide initiatives and issues.
  • Exceptional meeting facilitator, taking 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 GCP.
  • Accurately assesses key areas of risk in the GxP area and proactively develops appropriate actions to mitigate risk areas.
  • Leverages comprehensive knowledge of both audit conduct and regulation to respond to complex compliance-related queries.
  • Demonstrates solid understanding of cross-functional interdependencies across the drug development life cycle and potential conflicts.
  • Understands how studies support overall program objectives and strategy for therapeutic area and required filings.
  • Comprehensive understanding of the dependencies between risk management and strategic objectives.
  • Maintains broad industry knowledge around GCP, risk and inspection management.
  • Able to manage and resolve inspection management challenges or roadblocks throughout the inspection lifecycle.
EDUCATION
BA/BS degree (advanced degree preferred) with a focus on life sciences or a related scientific or technical discipline

EXPERIENCE
  • 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

MAY REQUIRE UP TO 25% TRAVEL


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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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