- Twist BioScience (South San Francisco, CA)
- …The Director will serve as the primary technical and strategic expert for all MES-related initiatives.Key ResponsibilitiesStrategic Leadership & Architecture: Define ... MES, ensuring scalability, maintainability, and alignment with biomanufacturing strategy, GxP regulations, industry best practices, and technological advancements in… more
- Novo Nordisk Inc. (Durham, NC)
- …make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. ... improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in line ... / metrics to proactively address operational risksServe as a regional Process expert regarding maintaining a compliant set of procedural documentsWork with RA and… more
- Experis (Cambridge, MA)
- …ensure a cross functional evaluation is completed and ensure alignment of GxP practices. Responsible for compliance with Controlled substance documentation and ... Description: The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation… more
- ProPharma Group (Western Springs, IL)
- …Requirements Minimum 10 years relevant experience in quality assurance and regulatory GxP compliance . Minimum 3 years managing a technology business or ... expertise in regulatory sciences, clinical research solutions, quality & compliance , pharmacovigilance, medical information, and R&D technology, ProPharma offers an… more
- Ascential Technologies (San Diego, CA)
- …SaaS System Management Serve as the primary system administrator and subject matter expert (SME) for the company's eQMS platform and potentially related SaaS systems ... and other relevant electronic record-keeping systems are implemented and maintained in compliance with FDA 21 CFR Part 11 requirements for electronic records and… more
- Bristol-Myers Squibb Company (Bothell, WA)
- …Aseptic Processing & Environmental Controls provides support to ensure the compliance of aseptic processes and environmental control systems. Senior Engineer - ... lifecycle information management system and Infinity Serve as a subject matter expert (SME) for aseptic and environmental control programs with strong technical… more
- Charles River (Cleveland, OH)
- …decisions within a single operational area Develop understanding of compliance expectations to respond to quality assurance audit observations in ... Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs,… more
- Bristol-Myers Squibb Company (Bothell, WA)
- …The Sr. Engineer I, Validation will play a critical role in ensuring compliance with all regulatory requirements and industry standards related to GMP asset ... plans to support GMP operations. Acts as a validation Subject Matter Expert (SME) providing support to multi-function teams, advises operations on validation… more
- Vera Therapeutics (Brisbane, CA)
- … GxP system. * Provide IT support for audits and inspections related to GxP systems, acting as the subject matter expert on technical architecture, validation ... Title: Job Title: Associate Director, GxP Systems Location: Brisbane, California About Us: Vera...role will play a pivotal part in supporting regulatory, compliance , and operational readiness for commercial launch. Working with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for planning SOPs, Work Instructions, business policies and procedures to ensure GxP compliance . Influence cross-functional SOP content and review/approve as ... drugs and other co-meds for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents… more
- Novo Nordisk (Clayton, NC)
- …areas (aseptic, inspection, assembly, packaging, utilities & laboratories) required + Expert in GxP documentation practices required + Proficient in ... help us make what matters. The Position The IT Compliance Engineer is responsible for ensuring that IT ...+ Excellent oral & written communication skills required + Expert in DI gap analysis and remediation required +… more
- Sanofi Group (Cambridge, MA)
- …+ Compliance of Computerized systems (REMS, GDPR, PHI, PII, GxP ) + Patient Service/Healthcare experience desired **TRANSVERSAL SKILLS & COMPETENCIES (SOFT ... cloud technologies, batch data processing, real-time API integration, and regulatory compliance for pharmaceutical or healthcare systems. The role ensures that our… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and oversight forums. + Business support: Drive process monitoring/adoption and GxP risk profiles through overseeing data collection, analysis, trending and ... with internal and external stakeholders to ensure alignment and compliance with QRM processes. + Provide direction and critical...the process design for managing major disruptions to the GxP business including how to respond in a Risk… more
- Cambrex High Point (High Point, NC)
- …You Matter by applying today! Job Overview The Senior Scientist, Regulatory Compliance will provide oversight of regulatory compliance activities to develop ... and implement regulatory strategies to ensure compliance with regulatory standards and client expectations with regulatory filings. Responsibilities + Provide… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated ... reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance , R&D quality and fit-for-purpose to both Gilead business needs and regulatory… more
- Kelly Services (Clayton, NC)
- …Quality systems + Documentation and data integrity + Laboratory operations + Regulatory compliance (GMP/ GxP ) + Budget planning and oversight + Employee relations ... + Provide expert guidance to manufacturing and regulatory departments on GxP -related matters. + Make informed, independent decisions within the defined scope of… more
- AbbVie (Worcester, MA)
- …Systems organization. This role is central to ensure that all data used in GxP systems are connected, accurate, secure and in full compliance with AbbVie's ... and analytics. This role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations, champion key site initiatives, and… more
- CBRE (Tempe, AZ)
- …contract terms. **ESSENTIAL DUTIES AND RESPONSIBILITIES** Oversees the day-to-day Quality and Compliance Team operations at one account sites (may also support CBRE ... client specific). Monitors operations at the site and determines compliance status with regards to local and global regulatory...for the site. Has the responsibility to ensure all GxP service providers are qualified per the CBRE regulated… more
- Capgemini (NY)
- …and design innovative, streamlined solutions. + Oversee system validation activities to ensure compliance with GxP , 21 CFR Part 11, and other regulatory ... standards. **Your Role** + Serve as the subject matter expert for Veeva Vault Quality, guiding system design and...knowledge of life sciences regulations and quality standards, including GxP and 21 CFR Part 11 compliance .… more
