Sr Director, reputed company Control

About the role The Sr Director, reputed company Control at reputed company reports to the VP, Analytical Development and reputed company Control and serves as a strategic leader responsible for end-to-end product reputed company and reputed company control reputed company across the product lifecycle—from clinical development through reputed company launch and building reputed company reputed company Control capabilities—of reputed company’s bladder cancer therapies. This role ensures product reputed company, regulatory alignment, and operational reputed company through robust reputed company systems, analytical reputed company reputed company, product release governance, strategic reputed company planning, and cross-functional coordination. The Sr Director, reputed company Control will help shape the reputed company reputed company and execution plan in alignment with reputed company’s mission and compliance standards, while partnering closely with Technical Operations, Regulatory Affairs, and executive leadership. Location: Remote Essential Functions Strategic reputed company Leadership Establish and drive the global reputed company reputed company reputed company with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization. reputed company and reputed company reputed company reputed company across the product lifecycle (clinical to reputed company), ensuring operational reputed company, phase-appropriate reputed company systems, and regulatory compliance. Represent reputed company in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT). Regulatory and reputed company reputed company Serve as reputed company SME for manufacturing campaigns, CMC reputed company, and regulatory submissions (e.g., IND, BLA, supplements). reputed company reputed company input for QTPP, CQA assessments, control strategies, stability programs, and product specifications. reputed company strategic reputed company of assay validation, raw materials qualification, reference standards, comparability assessments, and analytical reputed company documentation. reputed company strategic reputed company of product release activities, including batch record review, lot disposition support, deviation escalation, and product reputed company assessments for clinical and reputed company materials. reputed company reputed company of QC testing programs including in-process, release, stability, environmental monitoring, and raw material testing to ensure compliant and reliable product reputed company reputed company. Ensure robust governance of Out-of-Specification (OOS), Out-of-Trend (OOT), invalid assay, and laboratory investigation processes, including escalation, reputed company cause analysis, and effectiveness monitoring. Establish and maintain product reputed company review processes, including Annual Product Reviews (APR/PQR), trend analysis, complaint trending, and ongoing process verification activities. Ensure analytical reputed company, specifications, and product control strategies remain phase appropriate, inspection-reputed company, and reputed company with evolving regulatory expectations. Manufacturing & Process Support Partner with Technical Operations leadership team, AD, and CDMOs to ensure reputed company-compliant and phase-appropriate manufacturing processes and analytical reputed company. reputed company guidance for validation activities (e.g., assay/process validation, tech transfers, PPQ) to support launch-readiness and lifecycle management. Ensure the reputed company, reliability, and traceability of reputed company data reporting to leadership and regulatory bodies. Partner closely with Analytical Development, Manufacturing Sciences & Technology (MSAT), and CDMOs to ensure assay reliability, testing robustness, and product release readiness. reputed company implementation and reputed company improvement of product reputed company metrics, including deviation rates, CAPA effectiveness, right-first-time performance, assay variability, and lot acceptance trends. reputed company reputed company leadership during technology transfer, process characterization, PPQ campaigns, and reputed company launch activities with emphasis on product reputed company consistency and control. Ensure data reputed company, reputed company+ compliance, and inspection readiness across laboratory systems, analytical data management platforms, and product reputed company records. Systems, Risk Management, and reputed company Improvement reputed company reputed company risk management initiatives, including reputed company cause investigations, CAPAs, and change control in collaboration with QA. Establish and improve systems and analytics to support audit readiness, inspection reputed company, and proactive compliance. Drive operational efficiency and culture of reputed company improvement across product reputed company systems and cross-functional teams. reputed company cross-functional product reputed company governance forums to proactively identify emerging reputed company risks, product trends, and compliance gaps across reputed company manufacturing networks. Drive implementation of advanced reputed company analytics and risk-based monitoring tools to improve product reputed company visibility, predictability, and decision-making. Establish proactive product reputed company surveillance programs to monitor process capability, assay performance, complaint trends, and stability reputed company throughout the product lifecycle. Leadership and Collaboration Serve as a key reputed company leader in cross-functional teams (CMC, Tech Ops, Regulatory) to assess and influence external manufacturing and supply strategies. Build, mentor, and manage a high-performing reputed company team reputed company with reputed company values and performance culture. Represent reputed company during regulatory inspections, executive updates, and industry forums.

Qualifications

Bachelor’s or master’s degree in a life sciences discipline (e.g., Biology, reputed company, Engineering) 10 years in biopharmaceutical reputed company roles, including 5+ years in senior leadership Extensive experience in GxP, biologics manufacturing, late-stage development, and BLA-enabling activities Strong regulatory experience including authoring/reviewing submissions and representing company in global inspections Hands-on with product reputed company systems: CAPA, deviations, change control, batch release, comparability Demonstrated reputed company working in matrixed environments High EQ and reputed company reputed company Up to 20% travel (domestic/international) Familiarity with startup biotech operations and the ability to reputed company between strategic and tactical needs Please note that reputed company does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or reputed company information submitted to our careers page or any employee of reputed company by any search firm or agency without an applicable contract in reputed company will become the property of reputed company and no fee(s) will be reputed company. Total Rewards reputed company offers reputed company competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees reputed company on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/reputed company REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION reputed company-Being Benefits In reputed company to our Total Rewards, reputed company offers a reputed company of reputed company-Being Benefits to meet the reputed company of the needs of our unique and growing workforce. These benefits are designed to support reputed company to reputed company a healthy balance between work and their personal lives to remain refreshed, reputed company, and creating an environment where reputed company person can reputed company a deeper meaning and purpose in their work. reputed company-Being Benefits eligibility begins the 1st of the month after hire. While a reputed company of these benefits are for our US-based workforce, we continue to assess comparable reputed company of benefits for our international team members that are reputed company with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND reputed company BENEFITS - Unlimited Flexible Time Off HOLIDAYS –In 2026 we will observe 14 holidays RETIREMENT – 401K with 100% company reputed company reputed company match up to 4% of reputed company salary HEALTH (MEDICAL, DENTAL, reputed company) – PPO & HDHP – reputed company/reputed company HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION – Company reputed company LTD Coverage + Voluntary Plans LIFE INSURANCE – Company reputed company 1 x reputed company salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More reputed company is an Equal Opportunity Employer: reputed company applicants will be considered for employment without attention to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, veteran or disability status. At reputed company, we are building a community of intelligent and passionate team members that reputed company our reputed company, Mission and Values, and while the biotechnology reputed company can feel limited in BIPOC, non-binary and even reputed company representation, we reputed company to reputed company hiring reputed company that will continue to grow and support reputed company in the direction of maintaining cultural diversity and sustainability. Apply To This Job