Global Training Compliance- Corporate Quality
About The Position
About This Role: As the Global Training Compliance - Corporate Quality, you will be at the forefront of ensuring the quality and compliance oversight and execution of our global GxP Training process as member of the Corporate Quality team. This pivotal role involves acting as Quality Unit for the Global GxP Training process and the Business System Owner for the Veeva Vault Training system, ensuring its alignment with both regulatory standards and organizational objectives. You will spearhead the design, implementation, and ongoing improvement of this system, collaborating with cross-functional teams to maintain high compliance standards. By monitoring metrics and KPIs, and escalating issues to senior leadership, when necessary, you ensure that our training process is not only efficient but also enhances our global operations. Your insights will be invaluable during audits and inspections, as you represent the process to regulatory bodies. Embedded within a global framework, your role is crucial for harmonizing training compliance across our sites and functions, enhancing our operational integrity and excellence. This is a hybrid role to be based at our offices in Research Triangle, Park, NC.
Requirements
- Minimum 7 years of experience in a similar role within the pharmaceutical or biotechnology industries.
- Diploma, Bachelor’s, or Master’s degree in a scientific field.
- Profound knowledge of cGMP requirements and IT quality systems.
- Previous experience in Training and/or Learning Development.
- Strong project management skills, preferably with lean six sigma certification.
- Expertise in Veeva Vault Training or similar IT systems.
Nice To Haves
- Experience in global project management.
- Ability to lead and influence cross-functional teams.
- Excellent understanding of systems implications for compliant training process.
Responsibilities
- Provide quality and compliance oversight to the global GxP Training process
- Lead the maintenance of the Veeva Vault Training system across all Biogen sites.
- Act as a liaison between global functions, providing leadership and guidance on day-to-day process issues.
- Facilitate regulatory updates assessments and track action plans
- Develop and roll out annual GxP refresher training for PO&T functions.
- Ensure system design reflects customer needs for global alignment.
- Define and prioritize improvement projects for the GxP Training system.
- Document business requirements and collaborate with IT for system enhancements.
- Approve system access requests and ensure compliance with training standards.
- Establish global metrics for process performance and report to senior leadership.
- Manage deviations, CAPAs, and change controls related to training process.
- Conduct risk assessments and manage quality risks in the global register.
- Present Training process during inspections and audits and implement corrective actions as needed.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
