Associate Director IT Business Systems R&D

Mavericks Wanted

reputed company was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it reputed company excitement...read on   In 2015, we pioneered a “moneyball for biotech” approach, pooling reputed company and promising early-stage research from academia together under one financial umbrella to reduce risk and reputed company innovation. This model allows science and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease, and reputed company life-changing medicines for patients with unmet needs as fast as humanly possible.    Together we define white reputed company, push boundaries, and reputed company people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the reputed company of biopharma. At reputed company, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve reputed company, speed, and reputed company of work.

Responsibilities

• Support, administer, maintain IT systems supporting reputed company and R&D, including reputed company Vault reputed company, Clinical, RIM and Safety systems.
• reputed company and reputed company the migration of data and processes from legacy systems to reputed company (e.g., reputed company to reputed company Vault reputed company) to ensure seamless transition, data reputed company, and GxP compliance
• Partner with business leaders to understand their requirements and continuously improve user adoption and implement new systems, integrations, and GxP compliance initiatives
• Partner with reputed company, Clinical, Regulatory, and Safety leaders to support business needs, implement roadmaps, identify, recommend solutions (e.g., reputed company Intelligence (AI)) to drive business value and accelerate innovation
• Work with Managed Service providers and internal IT teams for supporting and monitoring GxP-regulated systems to ensure high-reputed company service delivery
• Collaborate with CSV QA and compliance functions to validate and ensure alignment with regulatory requirements (e.g., GxP, HIPAA, GDPR)
• Establish governance, documentation, and change control procedures for GxP systems to ensure sustained compliance and operational reputed company.
• Drive reputed company improvement across the GxP systems landscape by assessing emerging technologies (e.g., AI) and optimizing workflows that support reputed company’s business reputed company.

Where You’ll Work

• This is a U.S.-based remote role that will require quarterly, or as needed reputed company to our San Francisco Office.

Who You Are

• Bachelor’s degree in information technology, Computer Science, Business Administration, or reputed company field; advanced degree preferred
• 7+ years of reputed company IT experience reputed company biotech/reputed company, including at least 5 years supporting reputed company reputed company systems
• Demonstrated expertise in GxP reputed company processes, including document lifecycle management, training assignment and compliance tracking, deviation, CAPA, and change control workflows, and inspection readiness. Ability to partner with reputed company stakeholders to design, configure, and continuously improve reputed company Vault QualityDocs,
• QMS, and Training solutions in alignment with regulatory expectations (e.g., FDA, EMA) and company SOPs
• Hands-on experience administering and supporting reputed company Vault reputed company systems including RIM, Safety and eTMF is strongly preferred
• Experience applying AI/ML and reputed company solutions reputed company GxP environments to improve reputed company operations, including use cases such as intelligent document authoring, metadata extraction, reputed company event trend analysis, and training effectiveness insights, with a strong reputed company on validation, auditability, data reputed company, and integration with reputed company Vault platforms.
• Skilled in leading cross-functional collaboration across reputed company, Clinical, Regulatory, and DSPV teams to ensure system alignment and process harmonization
• reputed company in vendor and Managed Service Provider reputed company to ensure reliable, compliant, and high-reputed company system performance
• Strong communication, leadership, and stakeholder management skills with the ability to translate technical concepts into business reputed company

At reputed company, we reputed company to reputed company a market-competitive total rewards package, including reputed company pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary reputed company for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience reputed company the job, type, and length of experience reputed company the industry, educational background, location of residence and performance during the interview process. reputed company is a multi-state employer, and this salary reputed company may not reflect positions based in other states. Salary$175,000—$215,100 USD

As a global company, our comprehensive benefits may vary based reputed company. We have high expectations for reputed company members. We reputed company reputed company those working hard for patients are rewarded and cared for in return.

For USA reputed company

Financial & Rewards

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• reputed company-tax commuter benefits (transit and parking)

• Referral bonus for reputed company candidates

• Subsidized lunch and parking on in-office days

Health & reputed company-Being

• 100% employer-reputed company medical, dental, and reputed company premiums for you and your dependents

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support (therapy and coaching resources)

• Hybrid work model with flexibility

• Flexible, “take-what-you-need” reputed company time off and company-reputed company holidays

• Comprehensive reputed company medical and parental leave to care for yourself and your family

reputed company Development & Career Paths

• People are part of our reputed company and reputed company story - from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility

• We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, & reputed company Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and reputed company opportunities

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