Sr. Manager, Global Training

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

Senior Manager, Global Training (Quality Assurance)

General Position Summary/Purpose:

Responsible for the management of the Pharmacyclics electronic learning management system and for the deployment of training accessibility across all global sites. Responsible for monitoring the effectiveness of the learning management system and maintaining compliance with policies, procedures, and applicable GXP regulations .

Key Accountabilities/Core Job Responsibilities:

• Manage the training department staff or individual growth, and effective performance.
• Interact with department/site management and training coordinators to ensure training curricula are specific to department/site needs and ensure that department/site staffs are effectively trained on corporate policies, department processes, GXP procedures, and regulatory training requirements.

• Ensure all employees have a training plan that covers their basic corporate training and on the job training according to their career path.

• Develop processes and tools to confirm the effectiveness of the learning management system as well as training metrics to ensure an optimized training system.
• Maintain close working relationship with various department training coordinators and subject-matter experts to enhance the access/delivery of training content and identify opportunities for training system improvement.
• Work with all levels of management to determine core functional competencies required for each position in the organization.
• Manage and maintain the ongoing GXP refresher training program. Ensure that GXP employees are provided with current GXP training content on a scheduled basis, schedule GXP training on a defined yearly schedule, and track GXP refresher training completion.
• Acquire and maintain in depth knowledge of GXP compliance trends in order to develop strategies for the delivery of high quality training courses that are relevant to the needs of the PCYC organization.
• Work closely with the Training department members to establish and manage the department budget within 5%.
• Lead the development of LMS and serve as the system subject-matter expert to support and engage training partners. Lead the description of the training system and associated metrics during regulatory agency inspections.

Qualifications/ Experience:

• 8 + years experience leading training initiatives and programs for an organization. Previous training experience in the biotech or pharmaceutical industry is highly preferred.
• Experience with providing general supervision to staff members and managing performance.
• Experience managing and implementing learning management systems.
• Experience developing and implementing course curriculums, assessments, testing and other processes to ensure the effectiveness of the learning and development activities.

Education Requirements (degree, certifications, etc.): Include must have and preferred

• BS/BA degree or equivalent, advanced degree desirable

Specific Skills/Abilities:

• Must have a firm understanding and application of domestic and international regulatory requirements in the development, clinical, and commercial areas of pharmaceutical products.
• Demonstrate a strong customer orientation working in a site capacity
• General knowledge and understanding of adult learning concepts.

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