Senior Manager, Commercial Product Quality
New
Based in the United StatesFull-TimeManager
SalaryCompetitive salary package with annual performance-based bonus opportunities and equity-based incentive program.
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Job Details
- Experience
- 8+ years
- Required Skills
- Quality AssuranceRisk Management
Requirements
- 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.
Responsibilities
- 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.
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