BeiGene is growing quickly, and we're searching for experienced professionals who are passionate about fighting cancer. We're looking for individuals who are highly motivated, enjoy working as part of a team, and have a strong scientific or business background.
About BeiGene BeiGene is a global pharmaceutical company committed to developing innovative cancer treatments.
The Role The Director, GCP Inspection Management will be responsible for overseeing activities related to inspection readiness, hosting, and coordinating GCP inspections conducted by various regulatory health authorities.
What You'll Do
- 🧑⚕️ Develop and Implement GCP Inspection Strategy: Create and execute a risk-based GCP inspection strategy.
- 🤝 Lead the Inspection Team: Manage a team of quality professionals and/or consultants to ensure inspection readiness, management, and hosting activities.
- 🤝 Collaborate Across Teams: Work with different teams (Clinical Operations, Pharmacovigilance, etc.) to make sure the inspection strategy is aligned and effective.
- ⏱️ Manage Inspection Commitments: Ensure timely communication with inspectorates and health authorities, including responding to findings and submitting inspection dossiers and pre-inspection requests.
- 📊 Track Inspection Outcomes: Keep an updated inspection forecast and track the results of each inspection.
- 🔄 Share Learning: Lead lessons learned sessions after inspections to identify trends and improve processes.
- 🗓️ Chair Meetings: Chair quarterly Cross-functional Inspection Oversight Committee (IOC) meetings.
- 📝 Manage Procedures: Guide and/or manage the creation and updates of relevant procedures.
- 📈 Report Trends: Monitor trends and report key investigation/deviation issues to management.
- 🧑🏫 Manage Training: Manage internal training programs and coordinate GxP training as needed.
- 💼 Represent R&D Quality: Participate in meetings and discussions on behalf of R&D Quality.
- 📊 Develop Metrics: Help create metrics to measure inspection data and drive continuous improvement.
- 💰 Manage Budget: Take part in budget forecasting, planning, and tracking to ensure activities stay within budget.
- 🧑🏫 Coach and Mentor: Provide coaching and mentoring to team members, including onboarding new quality staff.
- 🤝 Support Other Teams: Assist the GCP Inspection Management Team with other inspection types, such as GLP/GLP and PV inspections.
What We're Looking For
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Education: 10+ years of experience with a Bachelor's degree (Science preferred) or a Master's degree with 7+ years of experience.
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Experience:
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10+ years in the pharmaceutical/biotechnology industry.
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5+ years supporting GCPs and managing/hosting GCP Inspections.
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Skills:
- Ability to solve complex problems.
- Effective team management skills.
- Strong understanding of global regulations and cultural awareness.
- Ability to improve quality systems and department infrastructure.
- Excellent attention to detail and organizational skills.
- Demonstrated ability to set quality process improvement strategies.
- Leadership, strategic planning, analytical, and mentoring skills.
- Strong understanding of international regulations for clinical trials.
- Excellent project management and decision-making skills.
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Computer Skills: Proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
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Communication: Excellent verbal and written communication skills, ability to collaborate effectively.
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Travel: Up to 30% travel may be required.
BeiGene Global Competencies BeiGene's values – Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence – guide our 12 global competencies:
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Benefits
- 💰 Salary Range: $158,200 - $218,200 annually.
- 💰 Bonus Plan: Eligible for annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles).
- 💰 Equity: Opportunity to own shares of BeiGene Ltd. stock through discretionary equity awards and the Employee Stock Purchase Plan.
- 🏥 Comprehensive Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs.
Equal Opportunity Employer BeiGene is committed to fair and equitable employment practices. We don't discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected characteristic.
Job Category: Healthcare
Note: The salary range reflects the base salary only. The recruiter can provide more specific salary details during the hiring process.