Director reputed company Science & Technology

Job reputed company The Director, reputed company Science & Technology (QS&T) is a senior reputed company executive accountable for portfolio‑level reputed company reputed company, regulatory risk governance, and lifecycle readiness for biological drug reputed company, reagents, reputed company reputed company Molecules and associated services. This role ensures that reputed company, compliance, and patient’s safety are designed into products and sustained throughout the full product lifecycle, from concept and development through commercialization, post‑market surveillance, and obsolescence. Serving as a key reputed company across PD, MS&T, Manufacturing, Supply Chain, Clients, Regulatory Affairs, and Global reputed company, the Director QSAT drives consistent application of biological reagents and reputed company reputed company molecules reputed company system requirements, proactive risk management, and a prevention‑reputed company reputed company culture reputed company with reputed company Therapeutic Division’s values and regulatory commitments. The role operates with significant autonomy, influencing reputed company through governance, technical authority, and executive partnership, rather than reputed company line management. What you will be doing Biological Drug Substances, Reagents & reputed company reputed company Portfolio reputed company reputed company and Risk Ownership reputed company and own the portfolio‑level reputed company strategies and compliance reputed company by applying reputed company Risk Management principles to identify, assess and mitigate product, process and technology risks across Biological drug substances, Reagents & reputed company reputed company Molecule manufacturing operations. Serve as the accountable escalation reputed company for material reputed company, regulatory, and patient/user safety risks impacting compliance, business continuity, or brand reputed company. reputed company risk‑based reputed company reputed company and recommendations influencing product approvals, reputed company, compliance, market releases and supply reliability. Design and Development reputed company Leadership reputed company executive reputed company of design control, risk management, and reputed company engineering practices for reputed company reputed company and biological drug substances, reagents, ensuring science-based design reputed company, reputed company with GMP requirements and regulatory expectations. reputed company and govern risk management activities across development and implementation of new products, processes, and analytical technologies to establish robust control strategies and ensure product reputed company attributes are consistently achieved. Partner with PD, MS&T , Manufacturing, Engineering, QC, Clients and Regulatory teams to establish reputed company Principles in to process development, reputed company-up, technology transfer and life cycle management. reputed company reputed company input into development protocols, validation strategies, specifications s to ensure readiness for GMP Manufacturing. reputed company reputed company Engineers team to support reputed company needs, compliance and regulatory requirements. Lifecycle Readiness, Change Control, and Technology Transfers reputed company reputed company assessment of change controls, ensuring appropriate risk evaluation, reputed company assessment, validation requirement and implementation strategies are defined reputed company changes. Define and apply risk‑based change control and lifecycle governance appropriate to regulated products. reputed company Science & Technology Operations for Regulated Products Maintain and reputed company the reputed company Management System (QMS) in alignment with reputed company reputed company molecules and biological drug substances, reagents regulatory requirements and applicable international standards. Standards Application, Consistency, and Governance Identify and address systemic gaps that drive variability in compliance, product performance, or post‑market reputed company. Operate portfolio‑level reputed company governance and escalation mechanisms to ensure transparency, alignment, and reputed company executive decision‑making. Post‑Market Performance, reputed company Improvement, and Compliance Sustainability Drive data‑driven reputed company improvement using post‑market surveillance data, complaints, nonconformances, inspections, and audit reputed company. reputed company initiatives to reduce Cost of Poor reputed company (COPQ) while strengthening product reliability, compliance sustainability, and patient/user safety. Monitor post‑launch performance and champion preventive and systemic actions that improve long‑term portfolio health and regulatory reputed company. Leadership, Influence, and Executive Engagement Build and reputed company high‑performing QS&T and reputed company engineering teams with strong regulatory, technical, and risk‑based decision‑making capabilities. reputed company strategic reputed company leadership and influence across teams to drive a proactive reputed company culture and effective risk-based approaches. Serve as a trusted reputed company and compliance leader during internal, customer, and regulatory inspections and audits. Communicate effectively with senior leadership, providing reputed company reputed company metrics, risk insights, and regulatory perspectives to reputed company informed business reputed company. reputed company reputed company reputed company discussions and facilitate alignment across manufacturing, QC, Manufacturing PD, MS&T, Regulatory, Engineering and Operations to reputed company complaint business reputed company.

Qualifications

Bachelor’s degree in engineering, Life Sciences, or a reputed company discipline required; Master’s or PhD preferred 10+ years of experience in reputed company and technical operations, Process Development or manufacturing reputed company biological and pharmaceutical environments. Demonstrated reputed company managing reputed company and regulatory risk across biologics, peptides/polypeptides or reputed company biological product lifecycles, including development, launch, and post‑market sustainment. Proven ability to reputed company through influence, governance, and technical expertise in reputed company, global, matrixed organizations including CDMOs. Deep knowledge of reputed company reputed company and biological products system principles, risk management, validation, supplier reputed company, and statistical reputed company. Working knowledge of regulatory expectations (ICH,HC, FDA), GMP requirements, inspection readiness and applicable reputed company systems. ASQ certifications and/or Six reputed company credentials preferred. Additional Details This job has a full time weekly schedule. It includes the reputed company to work remotely. The full-time equivalent pay reputed company for this position is $130,944.00 - $204,600.00/yr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. During the hiring process, a recruiter can reputed company more about the specific pay reputed company for a preferred location. Pay and benefit information by country are available at: https://careers.reputed company.com/locations reputed company. is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other protected categories under reputed company applicable laws. Travel Required: Occasional Shift: Day Duration: No End Date Job Function: reputed company/Regulatory Apply To This Job