- Establish strategic roadmap for quality oversight of innovative therapeutic programs internationally
- Manage performance reviews and identify areas for improvement
- Provide guidance as a trusted advisor to business stakeholders
- Maintain expertise in compliance requirements
- Support risk management activities
- Lead quality projects and operational excellence initiatives
- Master's degree or equivalent
- Minimum 10 years of experience with at least 5 years in a leadership role in a pharmaceutical setting
- Expertise in EU health regulatory agencies and GXP life cycle
- Technical knowledge in Tissue regulations
- Familiarity with industry trends in Cell/Gene therapies
- Experience with gene- and cell therapy products
- Strong strategic planning and execution skills
- Excellent communication and influencing skills
- Ability to apply risk management principles effectively
- Critical thinking and problem-solving abilities
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Director, Apheresis Quality Operations - Boston, United States - Vertex Pharmaceuticals
Description
Director, Apheresis Quality Operations (Hybrid)
Location: Boston, MA
Employment Type: Full-time
Job Description: The Director, Cell & Gene Quality, International will play a key role in defining the strategy for the global expansion of Cell & Genetic programs. Responsibilities include setting up quality risk management plans, collaborating with various departments to ensure QA oversight is maintained, and leading the establishment of operational quality capabilities for Cell procurement and Infusion activities.
Required Qualifications:
Preferred Qualifications: Master's Degree in pharmaceutical or health sciences
Required Knowledge/Skills:
Other Requirements: Up to 15% travel may be required for this role.
Hybrid Eligibility: This role allows you to work remotely for up to two days per week or work on-site five days a week with some flexibility.
About the Company: Vertex is a leading biotechnology company dedicated to scientific innovation, focusing on developing transformative medicines for individuals with severe diseases. With a global presence, Vertex is committed to creating a diverse and inclusive work environment where employees can contribute their unique talents to drive innovation and change lives.
Company Vision: To be an inclusive and diverse organization that attracts top talent, fosters innovation, and positively impacts people's lives.