Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx)
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx) based in the United States.
Join a global healthcare organization advancing precision medicine through innovative therapies designed to improve outcomes for patients with cancer and rare diseases. In this senior quality leadership role, you will help ensure commercial product excellence by strengthening quality systems, supporting product lifecycle transitions, and driving compliance across complex pharmaceutical operations. You will collaborate with manufacturing partners, regulatory teams, and cross-functional stakeholders to deliver safe, reliable, and compliant products. This position offers the opportunity to influence quality strategy, lead continuous improvement initiatives, and contribute to the successful commercialization of advanced therapies within a dynamic, science-driven environment.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Commercial Product Quality (TLX250-CDx and TLX101-CDx) based in the United States.
Join a global healthcare organization advancing precision medicine through innovative therapies designed to improve outcomes for patients with cancer and rare diseases. In this senior quality leadership role, you will help ensure commercial product excellence by strengthening quality systems, supporting product lifecycle transitions, and driving compliance across complex pharmaceutical operations. You will collaborate with manufacturing partners, regulatory teams, and cross-functional stakeholders to deliver safe, reliable, and compliant products. This position offers the opportunity to influence quality strategy, lead continuous improvement initiatives, and contribute to the successful commercialization of advanced therapies within a dynamic, science-driven environment.
Accountabilities
- Lead commercial product quality activities for key pipeline and commercial-stage products, ensuring compliance throughout product lifecycle transitions.
- Develop, maintain, and improve quality management systems supporting pharmaceutical manufacturing and commercialization activities.
- Ensure alignment with global Good Manufacturing Practices (GMP), ICH guidelines, and regulatory expectations for active pharmaceutical ingredients, drug products, radiopharmaceuticals, and medical devices.
- Partner with contract manufacturing organizations, testing providers, and supply chain stakeholders to ensure quality standards and operational requirements are consistently met.
- Collaborate with cross-functional teams to identify quality needs early in product development and commercialization processes.
- Monitor quality performance through data analysis, trending programs, statistical assessments, and establishment of acceptance criteria.
- Provide regulatory guidance, risk assessments, and recommendations when compliance requirements cannot be fully integrated.
- Maintain accurate documentation, records, and quality-related activities in collaboration with internal teams and external partners.
- Drive continuous improvement initiatives, including root cause analysis, corrective and preventive actions (CAPA), and risk mitigation strategies.
- Mentor quality professionals and promote a culture of collaboration, accountability, innovation, and operational excellence.
- Bachelor’s degree in a scientific, engineering, or related discipline required; advanced degree preferred.
- 8+ years of experience in quality assurance within the pharmaceutical, biotechnology, or regulated life sciences industry.
- Strong knowledge of GMP, ICH guidelines, and global regulatory requirements, including FDA and EMA expectations.
- Proven experience developing, managing, and improving quality management systems in a regulated environment.
- Experience supporting commercial product lifecycles, manufacturing operations, and external manufacturing partners.
- Strong understanding of quality analytics, statistical methodologies, risk management, root cause analysis, and CAPA processes.
- Demonstrated ability to influence cross-functional teams and collaborate effectively with internal and external stakeholders.
- Excellent leadership, communication, and decision-making skills with the ability to manage complex priorities.
- Results-oriented mindset with strong problem-solving abilities and commitment to continuous improvement.
- Adaptable and resilient professional who thrives in dynamic environments and embraces change.
- Commitment to ethical behavior, inclusivity, collaboration, and ongoing professional development.
- Competitive salary package with annual performance-based bonus opportunities.
- Equity-based incentive program.
- Hybrid and remote work flexibility.
- Generous paid vacation time and wellness days.
- Learning and professional development opportunities.
- Opportunity to contribute to innovative precision medicine solutions addressing significant healthcare needs.
- Collaborative international environment with multidisciplinary teams.
- Meaningful role supporting the development and delivery of therapies that improve patient lives.