Senior GxP Training Manager - Corporate Compliance Policy, Training & Communications (Onsite Role)

SUMMARY / JOB PURPOSE :

The Senior GxP Training Manager for Corporate Compliance Policy, Training & Communications (PTC) is responsible for the support of GxP policies and training managed in support of enterprise-wide training activities.

This role will also support the maintenance of the GxP document management system. This position reports to the Associate Director, Corporate Compliance PTC.

This is an onsite role (5 days a week) based at our Alameda, CA location.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Assists with training activities that support our enterprise-wide training initiatives.
• Support GxP policy and training activities and manage electronic management tools (i.e., LMS, eQMS).
• Support eLMS duties.
• Supports functional management in creating, developing, and implementing GxP role-based curricula.
• Provides management, monitoring, support, and oversight of and reporting on training compliance.
• Identifies, assesses, and manages GxP risks / trends and recommends mitigation strategies to management.
• Leads pipeline of inventive, enduring, and innovative training experiences and approaches to skill development and knowledge acquisition.
• Establishes and maintains effective working relationships with key internal and external stakeholders.
• Develop, design, and create training in partnership with stakeholders

SUPERVISORY RESPONSIBILITIES :

No supervisory responsibilities

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

• Bachelor’s degree in life sciences or engineering and a minimum of nine (9) years of related experience; or,
• Master’s degree in life sciences or engineering and a minimum of seven (7) years of related experience; or,
• PhD in life sciences or engineering and a minimum of two (2) years of related experience, or;
• Equivalent combination of education and experience

Experience :

• Experience in the biotech or pharmaceutical industry is required.
• Experience with ComplianceWire and Veeva Vault or other eLMS / eQMS required.
• Previous training experience and knowledge of adult learning techniques required.

Knowledge / Skills :

• Excellent verbal, written, and presentation communication skills are required, including the ability to effectively communicate across the organization.
• Working knowledge of the laws and regulations for the pharmaceutical industry, including training requirements.
• Uses broad expertise and unique knowledge and skills to deliver on company core objectives and principles, and drive for results in creative and effective ways.
• Develops feasible and user-friendly technical solutions to complex problems.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Drives the successful completion of major programs, projects, and / or initiatives.
• Demonstrated proficiency in Word, Excel, PowerPoint and Visio or similar.
• Demonstrates excellent presentation and influencing skills, on all levels, gaining stakeholder buy-in, including executive leaders.
• Excellent organizational, decision-making, and time management skills to lead effectively in a fast-paced and innovative company.
• Effectively communicates, leads, and influences cross-functionally and with external partners and vendors.
• Ability to multi-task with multiple cross-functional projects.

WORKING CONDITIONS :

• Environment : primarily working indoors in an office environment
• No travel required

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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets.

The base pay range for this position is $140,000 - $199,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location.

The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.