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Associate Director, Training and Quality

BioMarin Pharmaceutical Inc.

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Location: San Rafael, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 13-0091 Required Education: High school or equivalent

Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 13-0091

The Associate Director Training and Quality will be the owner for Development Sciences Operations organization training program, and will lead the design, development and delivery of high quality and high impact learning in support of a culture of compliance. This role involves managing one or more direct reports as well as managing vendor partners to maximally deliver on the objectives for the training programs.

RESPONSIBILITIES:

Define Training Programs
• Lead the design, development and implementation of training activities related to new or revised Standard Operating Procedures (SOPs) and role based training for Development Sciences Operations and other relevant internal audiences.
• Partner with departments, subject matter experts and key stakeholders to identify training needs and improve functional area training solutions, focusing on performance-based activities and tools.
• Develop a deep understanding of common, core and critical cross-functional training needs
• Lead planning, implementation, and execution of training plans, including key message development for training, training program execution, training internal communications plan development and execution.
• Coordinate onboarding training for new-hires and ensures that training and development programs are implemented to support business needs.
• Participate in cross-company training teams and committees, as appropriate.

Implement Training Programs
• Design and deliver high quality training programs with significant complexity and impact on staff.
• Analyze, and evaluate training solutions, including interactive instructor-led courses, self-instruction, online learning, job aids, and other performance-based solutions.
• Work with key stakeholders and determine what they need to contribute for high quality delivery to occur.
• Partner with / manage resources including internal/external groups, colleges/universities and vendors to ensure delivery of high-quality training that helps advance the efficiency, productivity, and technical depth of personnel.
• Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with goals and the corporate training philosophy.

Facilitate Process Improvements
• Assist with process improvement projects and inspection readiness as needed.
• Create organizational development tools/programs that enhance effectiveness and efficiencies.

Review Quality and Compliance
• Establish training performance metrics and evaluation systems.
• Collaborate with GCP Compliance, Clinical Operations, and cross-functional team members to resolve audit findings, trend findings, assess associated risk, and propose solutions.
• Track compliance with training requirements, identifies knowledge gaps, and develops appropriate corrective and preventative action plans.

Supervise Direct Reports
• Drive the training strategy for rollout and lead the team to successfully deliver training programs.
• Develop and manage a strong training team (i.e. hires, trains, appraises, rewards, motivates, disciplines, etc.) ensuring that appropriate subject knowledge and skills are developed within each individual.
• Conducts performance reviews and regular 1:1 meetings.

To apply: Visit www.BMRN.com Job Code 13-0091

Requirements

EDUCATION:
• Doctorate degree OR
• Master’s degree & 5 years of directly related experience OR
• Bachelor’s degree & 7 years of directly related experience OR
• Associate’s degree & 12 years of directly related experience OR

EXPERIENCE/JOB REQUIRMENTS:

• Biotech/Pharma industry experience preferred in one of the following fields: Clinical Operations, Clinical Development, GCP Compliance, Pharmacovigilance, and /or Regulatory Affairs.
• Minimum 6 years training in Biotech/Pharma, with experience in development, implementation and delivery of clinical training.
• Solid understanding of ICH/GCP, CFR and the clinical development process.
• Self-starter and results oriented. Strong ability to establish direction, motivate and inspire team members. Able to work with staff across all levels of the organization.
• Proven project management and problem solving ability.
• Excellent computer skills required; including proficiency in computer applications such as Excel, Word and PowerPoint. Ideally have experience designing and development of eLearning, and use of tools such as Articulate, Captivate, Flash, and experience with graphic design tools (Photoshop, Illustrator).

To apply: Visit www.BMRN.com Job Code 13-0091
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