Associate Director, GxP Compliance Strategy - Inspection ManagementLocation San Rafael, California Workstyle Open to Hybrid Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
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 Inspection Management and Emerging Regulation within GxPs Compliance Strategy team is responsible for providing a standardized approach to management of BioMarin’s global GxP inspections (including establishing policies, procedures, playbooks, best practices, and guidelines). The inspection management team collaborates with functional areas to ensure on-going inspection readiness, and provides global inspection support across GxPs (pre, during and post inspection activities). In addition, the emerging regulations space within Strategy is responsible for proactively identifying emerging regulations and assessing their impact on BioMarin, as well as partnering with subject matter experts to determine the required response, facilitating the resolution of identified gaps to ensure compliance, and monitoring the effectiveness of BioMarin response to new regulations.
Associate Director, Inspection Management high-level summary:
The Associate Director supports BioMarin’s efforts focused on the management of Health Authorities Regulatory Inspections. This role leads the readiness activities of the Inspection Management team, which includes participating in the on-going inspection readiness activities for phase III programs, supporting pre-inspection preparation, and participating in executing the inspection and post-inspection follow-up activities.
Proactively support the Emerging Regulation Program by identifying emerging regulations and assessing their impact on BioMarin. This includes sourcing emerging regulations from regulatory policy, regulatory intelligence, and regulatory authority communications, evaluating emerging regulations and their impact on BioMarin, partnering with subject matter experts to determine the required responses, facilitating the resolution of identified gaps to ensure compliance, and monitoring the effectiveness of BioMarin’s response to new regulations.
Inspection Management Readiness Program Oversight
- In collaboration with other members of the GxP Compliance Strategy Team, develop the inspection readiness program in the GxP space including Pre-Clinical, Clinical and Pharmacovigilance space.
- Develop metrics around inspection readiness
- Escalate and report inspection risk issues to leadership team
- Assist with documenting strategy on complex issues
- Maintain inspection risk matrix for the various programs
- Conduct and assist with Mock Inspection Interviews and coaching SMEs for HA interviews.
- Support inspection execution efforts, including:
- Lead and / or support the various BioMarin GxP inspections backroom teams and participation in the front room to ensure smooth execution of the inspection, including fulfillment of inspection requests in a timely manner and management of daily logistics
- Facilitate daily wrap-up meetings and send daily notification emails of inspection progress
The Associate Director will be a subject matter expert. This position will contribute to and make an impact on the department and the cross-functional process.
This position has no direct reports but may lead cross-functional inspection readiness teams.
Core Competencies required
- Breaks down complex and ambiguous problems into manageable components for investigation and applies logic to problem definition
- Demonstrates the ability to influence and communication with all levels of the organization to positively influence inspection outcomes.
- Demonstrate the ability to work under pressure for the duration of the inspection.
- Demonstrate flexibility to work odd hours to accommodate Health Authority schedules.
- Exhibits a focus on performance measurement to track progress toward objectives
- Develops and delivers well organized and effective presentations to any level of the organization
- Leads the development and implementation of strategic plans that link task to strategy achievement at a regional or single compound focus
- Comprehensive understanding of key roles, such as site inspection lead and inspection readiness lead, throughout all phases of the inspection management lifecycle
- Comprehensive knowledge of global regulations and guidance in one or more GxP areas of focus; outside of primary focus area, holds basic familiarity with global regulations in one or more additional GxP areas
- Leverages comprehensive knowledge to respond to complex inspection related queries
- Demonstrates solid understanding of cross-functional interdependencies across the drug development life cycle and potential conflicts
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline; advanced degree preferred
- 10+ years of experience with BA/BS in a biologic, gene therapy manufacturing, quality assurance, or validation environment; audit or inspection experience highly desirable; 8+ years with MA/MS
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 Regulatory, Clinical Operations, Medical Affairs, and Senior Leadership Team.
May travel up to 25% of the time.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.