Global Training Compliance- Corporate Quality
Biogen
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.
What You’ll Do:
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.
Who You Are:
You are a detail-oriented professional who thrives in a global setting, committed to maintaining high compliance standards. Your ability to lead complex projects and your expertise in training development make you a valuable asset to any team. You possess a deep understanding of business needs and excel in collaborating with cross-functional teams. Your proactive approach and strong communication skills allow you to navigate and influence various stakeholders effectively. You are driven by the desire to continuously improve processes, ensuring they are aligned with both regulatory requirements and business objectives.
Required Skills:
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.
Preferred Skills:
Experience in global project management.
Ability to lead and influence cross-functional teams.
Excellent understanding of systems implications for compliant training process.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.