Description

• Commercial QA Strategy: Define and execute a robust quality assurance strategy tailored for commercial operations, aligning with commercialization goals and global regulatory standards.
• Quality Systems Implementation and Optimization: Oversee the establishment, maintenance, and continuous improvement of commercial-stage quality systems. Drive continuous improvement initiatives and projects to improve processes and the QMS.
• Regulatory Compliance and Inspection Readiness: Serve as the quality lead in interactions with regulatory authority inspectorates (FDA, EMA, etc.) and other external auditors and ensure audit readiness to support both planned and unplanned inspections.
• Cross-Functional Collaboration: Work closely with Manufacturing, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, and other key teams to embed quality into each phase of the development and commercialization process, ensuring all processes support consistent quality and compliance standards.
• Product Quality Lifecycle Management: robust quality management systems to support the entire product lifecycle from pre-clinical to maturity.
• Supplier and Partner Quality Management: Develop and oversee supplier qualification and audit programs to ensure that all third-party manufacturers, packagers, and distributors consistently meet quality standards.
• Risk Management and Issue Resolution: Lead risk assessments, implement mitigation strategies, and manage quality-related issues in the commercial supply chain to minimize risk to patients and business operations.
• Team Development and Leadership: Mentor and lead a high-performing QA team to ensure a culture of quality across the organization. Provide guidance, training, and development to keep the team up to date with evolving quality and regulatory standards.
• Quality Metrics, Reporting, and Continuous Improvement: Develop and monitor key quality performance indicators (KPIs) specific to commercialization. Regularly report quality performance to leadership, ensuring ongoing assessment and refinement of quality systems and processes.

• Education: Bachelor’s degree in Life Sciences or a related field; advanced degree desirable but not required.
• Experience: Minimum of 12 years’ experience in the pharmaceutical or biotech industry in a quality or related role, with 5+ years in a commercial-stage role.
• Experience in oncology or other high-impact therapeutic areas.
• Demonstrated success managing quality and regulatory compliance in a global environment.
• Demonstrated strong GxP knowledge and understanding of relevant global regulatory requirements.
• Demonstrated expertise in developing and leading quality strategies and organization, particularly in the pharmaceutical/biotech commercialization phase.
• Operational Excellence: Experience with implementing and managing GxP quality systems, risk management, and continuous improvement practices in a commercial setting.
• Leadership Abilities: Proven ability to lead and inspire a QA team, fostering a strong quality culture throughout an organization. Ability to work cross-functionally to drive quality initiatives in a collaborative, commercial-focused environment.
• Demonstrated hands-on experience with implementing and managing Quality Systems and process infrastructure.
• Analytical and Problem-Solving Skills: Strong skills in risk assessment, root cause analysis, and problem-solving, with experience managing complex quality issues in a high-paced, regulated environment.
• Communication Skills: Excellent verbal and written communication skills, with a proven track record of engaging and influencing internal and external stakeholders, including regulatory agencies.