OUR CULTURE: At Dohmen Life Science Services, an EVERSANA Company, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement. Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:
Caring: We are empathetic and respectful. We ask “How can I help you?” Committed: We are dedicated and persistent. We ask “How can I make it happen?” Creative: We are inventive and imaginative. We ask “How can I do it better?” Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?” Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”
The most important aspect of this position is to take responsibility to assure compliance to client and regulatory requirements, and provide tools to foster Performance & Quality Improvement (PQI) efforts, support and assist in the development and management of quality systems at DLSS – Emeryville in addition to conducting independent internal and external audits and to assess compliance with regulations, guidelines and operating procedures.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Continuously identify opportunities to improve operational processes, build in quality and assist in implementation across and within the DLSS – Emeryville location
Help to ensure that DLSS – Emeryville quality systems meet or exceed best practices and regulatory standards and participate in development strategies and plans to maintain and improve these systems
Live the DLSS corporate values of caring, creativity, commitment and collaborative behavior
Provide support and assist in the development and management of GxP (i.e., GVP, GCP, GDP, GAP) activities and quality systems at DLSS – Emeryville, including conducting independent internal and external audits to assess compliance with regulations, guidelines and operating procedures
Lead the implementation and support compliance documentation and controls within a standard quality management system across DLSS – Emeryville
Support activities to evaluate regulatory compliance
Provide support for Company regulatory GxP inspections, client qualification audits and routine/ad hoc audits; conduct external qualification and ongoing audits of vendors and client partners as needed
Provide client quality system and quality gap analysis consultation as requested
Partner with senior leadership to develop GxP audit strategy and implement inspection and audit readiness activities
Help prepare inspection and audit responses and ensure tracking of corrective actions to closure
Ensure that post inspection/audit commitments are tracked and completed on time
Assist in the implementation of corrective/preventive action plans and quality system improvements
Interact professionally with company management, internal departments, third parties and others relative to various quality initiatives
Recommend changes in standard procedures to reflect technological changes, regulatory trends and best practices
Provide support for collaborative efforts with Dohmen Corporate Quality leadership in overarching corporate quality initiatives
MINIMUM required qualifications:
MS, MPH, PhD or similar advanced professional Degree in healthcare or the life sciences preferred Minimum 7+ years in quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
Experience in pharmacovigilance and/or medical communications preferred.
Minimum 7+ years of experience in conducting audits.
Ability to communicate effectively at all levels of the organization and with key client and vendor stakeholders
Ability to align internal practices and partner across DLSS – Emeryville for high performance
Advanced professional Degree in healthcare or the life sciences preferred
Knowledge of quality assurance in GxP environment (i.e., GVP, GCP, GDP, GAP)
Experience in designing and implementing quality systems and procedures and audit conduct/readiness for the pharmaceutical and biotechnology industry or Quality Certifications
Knowledge of Microsoft Excel, Word, and PowerPoint, LMS, TrackWise
About Dohmen Life Science Services
Dohmen Life Science Services offers intelligent outsourcing for drug and device manufacturers to help you connect more closely with your customers, grow your business and realize your vision. As the industry shifts from volume to value, from siloed thinking to data-driven decisions, from transactions to a better patient experience, DLSS helps you create value for your customers and ultimately for your patients. And that’s just good business.
We offer the broadest set of outsourced services in the industry, all under one roof. Whether it’s navigating FDA requirements during development, commercializing products, managing daily operations or providing patient-centric care for the rare disease community, we can help you advance with speed, scale and certainty.