Sr. Manager, GxP Compliance - Regulatory Inspection ManagementLocation Cork, Ireland 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.
Senior Manger , GxP Compliance - Cork
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 GDPs 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.
The Inspection Management Senior Manager role supports the management of Health Authorities Regulatory Inspections by participating or leading the on-going inspection readiness activities, supporting pre-inspection preparation, execution, and post-inspection follow-up activities. Additional responsibilities include publishing Health Authorities response commitment status updates and supporting the inspection findings global assessment process. Understand and support emerging regulation function to ensure efficiency and lean operation.
Ongoing Inspection Readiness
Participate in ongoing inspection readiness efforts for global BioMarin operations, both commercial and clinical, including by:
- Participate or lead the on-going readiness team meetings
- Providing general and custom inspection awareness training
- Conducting or assisting with mock Inspection interviews and coaching SMEs for HA interview
- Tracking Post-inspection Commitments and providing inspection trends as requested.
- For third party GxP pre-approval inspections, support the sites in their preparation activities to ensure successful outcome.
- Assisting with and documenting strategy on complex issues
- Maintain inspection risk matrix for the various programs
Collaborate cross-functionally on pre-inspection readiness activities, including:
- Developing inspection notification communications
- Leading targeted country training
- Preparation of inspection requests, inspector’s intelligence, and trends
- Review of previous inspection commitments to ensure that inspection commitment intentions are met
- Management of inspection logistics
- Participation in mock inspections.
- Maintenance of the SME list
- Participate in inspection preparation activities for contract manufacturing and contract laboratory testing
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
- Ensure inspection commitments are communicated and escalated as required; track to completion and ensure that the intended CAPAs are effective and in compliance with internal policies as well as with all applicable regulatory requirements (Effectiveness Checks)
- Collect, manage, and prioritize inspection area of improvements (near misses)
Inspection Management and Emerging Regulation programs oversight
- Provide Inspection support to BioMarin regional offices
- Compile inspection program metrics as required and report out to the various committees
- Prepare and deliver regulatory inspection risk summaries to senior management
- Support third party inspection by acting as a liaison between CMO, CLOs and BioMarin SMEs
- Lead proactive compliance efforts to identify relevant, emerging regulations, research compliance intelligence and compliance metrics for various sites and functions
- Lead emerging regulations activities, performing impact analysis and evaluation of how BioMarin’s internal processes should be modified to cope with the changing regulatory landscape; follow up on action items, and assure the systems for effectiveness checks are established
- Report results and progress to senior leadership team
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 has no supervisor responsibility.
- 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
- Readily accepts and acts upon coaching from peers and managers
- Develops and delivers well organized and effective presentations to any level of the organization
- 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 regulations in one or more additional GxP areas
- Comprehensive understanding of the product commercialization process through to product launch
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline
- 8+ years of experience in a biologic, gene therapy manufacturing, quality assurance, or validation environment; audit or inspection experience highly desirable with BA/BS
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, commercial operations, 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.