Manager / Sr. Manager, GxP Compliance Strategy, Business Operations
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 and identifying and mitigating risk through the Audit subfunction.
Within GxP Compliance, Business Operations is responsible for leading the growth of the continuous improvement culture. This includes creating, monitoring, managing, and maintaining meaningful organization operational metrics; evaluating data to make recommendations for future learning, process improvements, and training initiatives; and enhancing the education of BioMarin staff through training programs both within and outside of the Learning Management System. This subfunction is also responsible for development of a centralized compliance training program which will facilitate cross-training, standardizing ComplianceWire curricula, and managing and monitoring program participation. Additionally, creation of monthly summary executive reports, enabling identification and driving of action plans to improve departmental key process indicator performance.
As a Business Operations member, the Manager/Sr. Manager is responsible for the following:
Operational performance measurement and improvement
- Improves capabilities of the GxP Compliance organization by managing the overall long- and short-range planning objectives and operational key results.
- Identifies, prepares, and facilitates events and workshops to drive the identification and execution of process improvement initiatives.
- Establishes efficient processes and systems to track and report status of initiatives including resources, projects, savings, etc.
- Manages project prioritization and selection to maximize business and financial impact. Leads the planning and execution of high-impact improvement projects and strategies initiatives.
- Creates and maintains operational and financial metrics dashboards and reports that accurately measure GxP Compliance performance. Evaluate data to make recommendations for future learning, process improvements, and training initiatives.
- Establishes communication channels for sharing continuous improvement initiatives that may also impact customers, such as WWRD and TOPS.
- Measure and improve customer satisfaction levels.
- Leverage business process automation and use of artificial intelligence for process improvement.
- Manage departmental reporting and executive forums. Monitor and report on GxP Compliance progress, to ensure objectives and key results are accomplished efficiently and within established timeframes.
- Is aware and participates in forums managing system changes affecting the organization.
- Host process improvement workshops.
- Organize quarterly on-site and remote team meetings in support of the flexible work model.
- Keep abreast of emerging regulation in the GxP Compliance area and new learning methods.
GxP Compliance training curricula development and management
- Prioritize key short- and long-range learning goals and objectives in alignment with company strategic goals and direction
- Design, develop, and/or identify appropriate course curricula or programs where gaps exist.
- Manage GxP Compliance training (business process and LMS oversight) to ensure that the system is effective and efficient, implementing appropriate procedures and policies
- Ensure staff are assigned appropriate internal/external training and have a combination of training, education and experience to execute assigned responsibilities
- Support the onboarding process (including external consultants) by providing and maintaining onboarding materials and working with new hires to ensure training needs are met.
- Support the creation of and maintain roles and responsibilities documentation for Compliance Training in collaboration with other training groups.
- Collaborate with internal disciplines in creating meaningful individual development plans (IDPs). Monitor and drive their execution to support cross-training in other areas developing a flexible work force.
- Support training programs/modules for inspection readiness.
- Promote a culture of growth, continuous improvement, and learning through the creation of incentive programs and staff communications.
- Assists in developing strategy and works closely with other business operations leaders to ensure support and alignment with global processes.
- Partner with internal and external departments’ training representatives to create and execute Lunch & Learn education series, managing formal requirements, content, and schedule for the program. Ensure documentation of course content and attendance.
- Serve as the back-up GxP Compliance representative in any corporate training program forums, including participating on the Training Core Curricula Committee or engaging in any LMS system changes.
- Support and serve as a consultant to all levels of management and teams to ensure success in training and education.
Organizational development and standards
- Support the revisions to GxP Compliance Standard Operating Procedures (SOPs) and creation of applicable training requirements.
- Manage GxP Compliance intranet webpage content and presence.
The Manager/Sr. Manager 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 does not have any people management responsibilities.
CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
- Proactively seeks different ideas and perspectives from global team members, external stakeholders, vendors, and other functions as appropriate
- Creates a safe, respectful environment for sharing diverse, contrasting, multi-cultural views among team members and key stakeholders
- Provides context and articulates key messages effectively and with appropriate level of detail
- Consistently reinforces the link between individual, team and functional activities and company strategy achievement
- Demonstrates knowledge of Good Practices (GxP) guidelines and their impact on each stage of the trial (start-up through close-out)
- Skilled at developing interpersonal and interactive learning components for engaging courses based on instructional design principles
- Effectively communicates with key stakeholders the value of training initiatives and influences further investments as appropriate
- Able to direct multiple complex projects, such as the development of training programs, Lunch and Learn, and team initiatives
- BA/BS degree with a focus on life sciences or a related scientific or technical discipline; advanced degree preferred
- 6 - 8+ years experience in operations, project management, implementation and change management, executive communications, training program leadership, training design and learning management systems (LMS) 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 and staff in Regulatory, Clinical Operations, Medical Affairs, Quality, and others.
< 10% travel may be required
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.