Job Details
Senior Director, Quality- GMP & GCP
Location: Charlottesville, VA or San Francisco Bay Area
Rivus Pharmaceuticals is searching for a Senior Director, Quality to set and lead a scalable quality strategy to advance a new class of investigational medicines called controlled metabolic accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. This role will report to the COO. The individual is accountable for the quality of global GXP activities performed by and/or managed by Rivus R&D, CMC and eventually commercial products. Establish a scalable, risk-based model for quality, ensuring compliance with applicable regulatory requirements, guidelines, and laws. Provide strategic and tactical leadership and oversight of the Quality function. Manage the Quality activities internally and external vendors providing services to the company to ensure compliance with the full development lifecycle (early phase development products through commercial production).
Responsibilities
In conjunction with Rivus Management and GXP internal Quality functional areas, provide a demonstrable commitment to quality and compliance through the establishment and application of a phase appropriate Pharmaceutical Quality System.
Working with CMC stakeholders and external providers of GMP goods and services (CDMOs), provide independent tactical quality expertise for external manufacturing and distribution programs and oversee the GMP activities supporting material receipt, drug substance, intermediate, and bulk drug product manufacture, packaging and labeling, and batch review and disposition at Rivus CDMOs.
Develops and implements systems and provides for the tactical expertise necessary to ensure the compliance of GXP analytical activities supporting product and bioanalytical testing, material use, starting material, drug substance, intermediate, and bulk drug product manufacture, drug substance and drug product stability monitoring, and disposition.
Working with Rivus s Clinical Development, Operations, Medical Affairs, Pharmacovigilance, and other relevant stakeholders, develops and implements systems and provides for the tactical expertise necessary to ensure compliance of GCP activities including protection of the rights and safety of clinical trial participants and the reliability and integrity of clinical trial data.
Develops and implements systems and provides for the tactical expertise necessary to ensure the compliance and integrity of nonclinical laboratory studies intended to support research and marketing permits for regulated products, including all GLP regulated studies.
Develop and maintain Quality metrics ensuring their regular reporting and escalation of issues to management team. Lead any product recalls from the clinic or market.
Hire and provide oversight of Quality personnel with expertise in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP).
Develop and lead appropriate GXP training to promote a culture of quality across all GXP functions and personnel to enable a constant state of inspection readiness.
Ensure the maintenance and continual improvement of the Rivus Supplier Management program.
Qualifications:
BS 15+ years, MS 13+ years. PhD 10+ years of professional experience leading Quality functions, with in GXPs environment.
Experience designing, building, and developing a fit-for-purpose Quality function
Effective leadership skills to supervise, mentor, develop and manage Quality personnel
Broad regulatory knowledge of global drug development and commercial quality and compliance disciplines
Prior experience preparing an organization for health authority inspections
21 CFR 210/211, 2001/83/EC, USP, EP, ICH Guidelines, and knowledge of international GCP drug development regulations, including USA (FDA), EU (EMA, MHRA) and ICH Guidelines.
Excellent written and verbal communication skills to establish cross-functional relationships with internal and external stakeholders
Must have integrity and credibility as a respected leader to inspire Rivus personnel to achieve high levels of quality and compliance
Interested candidates may forward a CV and Cover letter to ...@rivuspharma.com
About Rivus Pharmaceuticals
Rivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving
cardiometabolic health by advancing a new class of medicines called controlled metabolic accelerators (CMAs). Rivus lead CMA is the investigational small molecule HU6 in development to treat obesity and associated metabolic diseases, including heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction-associated steatotic liver disease (MASLD) / metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes. For more information, please visit www.rivuspharma.com.