VP, CDMO Network Development

See Yourself at Telix

The Vice President, Network Development is responsible for leading the national strategy and execution of contract development and manufacturing (CDMO) activities. This role drives the development of internal drug manufacturing capabilities, including process optimization, formulation development, technology transfer, and ensuring compliance with national regulatory standards (including 21 CFR 212 & 211). The VP oversees manufacturing operations, quality management, and client engagement across domestic sites, ensuring alignment with corporate objectives and operational efficiency. This role also partners with the isotope strategy team thereby delivering cyclotron strategy, installation, and isotope production within the network, delivering new capabilities to support business growth.

Key Accountabilities:

• Process Development: Provide strategic oversight for the design, development, and optimization of manufacturing processes for drug substances and products, ensuring alignment with long-term business objectives and regulatory compliance.
• Formulation Development: Set the strategic direction for the development of pharmaceutical formulations, ensuring efficacy, safety, and stability while driving innovation to enhance product performance and market competitiveness.
• Scale-Up and Technology Transfer: Oversee and approve the national strategy for scaling processes from clinical to commercial production, ensuring seamless technology transfer across internal and external manufacturing sites while maintaining compliance with regulatory standards.
• Analytical Testing and Quality Control: Establish and govern the framework for analytical testing and quality control across the national network, ensuring product quality, consistency, and adherence to current Good Manufacturing Practices (cGMP).
• Cost Management: Direct national budget planning and resource allocation for CDMO activities, optimizing cost efficiency while delivering high-quality outcomes and supporting long-term financial sustainability.
• Client Engagement: Establish and nurture strategic partnerships with key national and global clients, aligning their needs with organizational capabilities. Shape long-term collaborative frameworks to drive innovation, expand market opportunities, and strengthen the company’s leadership in drug development and manufacturing.
• Project Management: Provide executive oversight for high-impact, cross-functional projects across the national network. Ensure projects align with corporate strategy, are delivered on time and within budget, and drive transformational change in manufacturing and client service capabilities.
• Communication: Set the standard for clear, consistent, and transparent communication with executive stakeholders, clients, and internal teams. Ensure alignment on strategic priorities, project milestones, and emerging opportunities while fostering a collaborative culture across the organization.
• Regulatory Strategy & Compliance: Establish and oversee the national regulatory strategy to ensure full compliance with 21 CFR 212, 21 CFR 211, and other applicable regulations. Anticipate regulatory changes, influence industry standards, and shape internal policies to maintain a proactive and compliant drug development and manufacturing environment.
• Executive Oversight of Documentation: Ensure the development and maintenance of comprehensive, audit-ready documentation for all regulatory submissions and inspections. Drive the standardization and governance of documentation practices across the national network to support regulatory approvals and business continuity.
• National GMP Compliance Leadership: Establish and govern the national strategy for Good Manufacturing Practice (GMP) compliance across all manufacturing sites. Ensure alignment with global regulatory standards, including 21 CFR 211 and 21 CFR 212, while proactively shaping internal policies to meet evolving regulatory expectations. Drive a culture of operational excellence and continuous improvement to maintain the highest standards of product quality and patient safety.
• Quality Assurance Governance: Oversee the design, implementation, and continuous enhancement of robust quality assurance systems across the national network. Set strategic quality objectives, ensure effective risk management practices, and provide executive-level oversight to guarantee compliance with regulatory frameworks. Engage with senior regulatory bodies and internal stakeholders to ensure quality systems meet both current and future business needs

Education and Experience:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, or Chemical Engineering or related field required; advanced degree (Masters, PhD, PharmD) preferred
• 15+ years of experience in pharmaceutical manufacturing and quality
• Demonstrated ability to develop and execute large-scale GMP compliance and quality assurance strategies, including designing and governing systems aligned with 21 CFR 211 and 21 CFR 212
• Proven track record of direct interaction with regulatory agencies (e.g., FDA, EMA) and leading successful outcomes for inspections, audits, and regulatory submissions
• Experience managing large budgets, optimizing resource allocation, and leading cross-functional teams to drive operational efficiency while maintaining compliance
• Ability to lead transformational change initiatives in quality systems and GMP compliance, including implementing innovative technologies and best practices to ensure continuous improvement
• Exceptional skills in communicating complex quality and regulatory strategies to C-suite executives, regulatory bodies, and other senior stakeholders

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills