Jobs
>
Los Angeles

    Head, Quality - Los Angeles, United States - Rivus Pharmaceuticals

    Rivus Pharmaceuticals
    Rivus Pharmaceuticals Los Angeles, United States

    2 weeks ago

    Default job background
    Description
    Head, Quality
    • GCP/GMP/GLP
    • Small MoleculesLocation: Charlottesville, VA or Bay Area, CARivus 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 Rivuss 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 complianceInterested candidates may forward a CV and Cover letter to .comAbout Rivus PharmaceuticalsRivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improvingcardiometabolic 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
  • Cascade Enterprises

    Head of Quality

    3 days ago

    Cascade Enterprises Huntington Park, CA, United States Freelance

    **Overview**: · Perrigo Company is committed to improving lives by providing high-quality, affordable self-care products that consumers trust. Join our team in Huntington Park, CA and help us achieve our mission. · We are currently seeking a Head of Quality (m/w/d) for our Herren ...

  • i-Pharm Consulting

    Head of Quality

    2 weeks ago

    i-Pharm Consulting Los Angeles, United States

    Head of Quality - Biologics - Cell & Gene · Head of Quality required to work for a niche Cell & Gene Therapy Biotech. Their focus has been on using a CRISPR discovery platform to decipher the genome to identify gene targets. Due to the success of their business, they're now grow ...

  • Fraser Dove International

    Head of Quality

    3 weeks ago

    Fraser Dove International Los Angeles, United States

    Fraser Dove International is partnering exclusively with a global Contract Development & Manufacturing Organization (CDMO). Operating in the US, they are committed to enabling flexibility and capabilities that cannot be found anywhere else. · Our client is seeking a team leader ...

  • i-Pharm Consulting

    Head of Quality

    2 weeks ago

    i-Pharm Consulting Los Angeles, United States

    Head of Quality - Biologics - Cell & GeneHead of Quality required to work for a niche Cell & Gene Therapy Biotech. Their focus has been on using a CRISPR discovery platform to decipher the genome to identify gene targets. Due to the success of their business, they're now growing ...

  • Rivus Pharmaceuticals

    Head, Quality

    2 weeks ago

    Rivus Pharmaceuticals Los Angeles, United States

    Head, Quality- GCP/GMP/GLP - Small Molecules · Location: Charlottesville, VA or Bay Area, CA · 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 meta ...

  • Kerry Search Partners

    Head of Quality Assurance

    3 weeks ago

    Kerry Search Partners Los Angeles, United States

    Global Life-Sciences Company ($50bn)High-performing & fastest-growing business unitForefront of technologyStrategic roleAre you a seasoned quality leader with a passion for driving strategic initiatives and delivering impactful results? Look no further We invite you to be part of ...

  • PACE

    Mental Health Consultant

    3 weeks ago

    PACE Los Angeles, United States

    **Mental Health Consultant Services** · **PACE Mission** · PACE is a community development organization that creates economic solutions to meet the challenges of empowerment, education, housing, environment, and business development in the Pacific Asian and other diverse communit ...

  • 8one8 Brewing

    Head Brewer Opportunity at

    3 weeks ago

    8one8 Brewing Los Angeles, United States

    We're thrilled to announce an exciting opportunity at 8one8 Brewing for a dynamic individual who embodies the spirit of craft brewing. We're on the lookout for a Head Brewer who not only possesses extensive experience in the art and science of brewing but also shares our commitme ...

  • TEACH-LA

    Placement Coordinator

    2 weeks ago

    TEACH-LA Los Angeles, United States

    : · The Placement Coordinator will be responsible for coordinating and overseeing the placement of Early Childhood Substitute Teachers in various early educational programs or settings, such as preschools, daycares, or Early Head Start and Head Start programs. The duties will inc ...

  • Kaiser

    Staff RN

    2 weeks ago

    Kaiser Los Angeles, United States Part time

    · $5,000 sign-on bonus for eligible external hires · Job Summary: · As the leader of the health care team, provides professional nursing care, utilizing the nursing process in accordance with established standards of care, policies, and procedures. Demonstrates performance consi ...

  • Orangetheory Fitness -- West Coast Fitness

    Regional Fitness Manager

    3 weeks ago

    Orangetheory Fitness -- West Coast Fitness Los Angeles, United States

    **Job Title**:Regional Fitness Manager (RFM) · **Direct Supervisor**:Director of Fitness · **Status**:Salaried exempt · **Location**:Greater Los Angeles Area · **COMPANY DESCRIPTION** · **_West Coast Fitness_** · West Coast Fitness is a leading franchisee of Orangetheory Fitness ...

  • Volunteers of America Los Angeles

    Data Entry Clerk Ii South La

    1 week ago

    Volunteers of America Los Angeles Los Angeles, United States

    **_VOALA_** · **_Helping Our Most Vulnerable Change Their Life Stories_** · **PAY RATE**: $ $20.57 PER HOUR · **Head Start** · Through our Head Start and Early Head Start programs, we work with children (infant - 5 years old) and their families to provide the skills, confidence a ...

  • SILVERBACK COFFEE OF RWANDA

    Assistant Baker

    3 weeks ago

    SILVERBACK COFFEE OF RWANDA Los Angeles, United States

    **Responsibilities**: · *Help our head baker Set up workstations *Prepare & bake to business standards *Anticipate needs of available baking items and act accordingly - Inventory *Follow and maintain health and safety guidelines *Stock products using FIFO methods · **Qualificatio ...

  • PACE

    Parent Educator

    2 weeks ago

    PACE Los Angeles, United States

    Position Compensation: $$24.3910/hr plus excellent benefits. · Pace offers a **Total Rewards Package** to its employees: · - 401k · - Vacation · - Sick pay · - 14 Paid Holidays · - Pet Insurance · - FSA - Flexible Spending Accounts and Dependent Care · - Employee Assistance Progr ...

  • NIA

    Creative Director

    1 week ago

    NIA Los Angeles, United States

    **About Us**: · Los Angeles based brand NIA embodies the essence of fearless femininity. Our brand is dedicated to crafting bold, fashion-forward pieces that empower women to express themselves unapologetically through their style choices. NIA delivers luxury-inspired designs wit ...

  • Jack in the Box, an independently owned and operated franchise

    Team Member

    2 weeks ago

    Jack in the Box, an independently owned and operated franchise Los Angeles, United States

    "Be confident. Climb high. Maybe you'll be a big head like me." -JACK · Responsible for delivering an exceptional guest experience by consistently providing excellent service, great tasting/quality food, and a clean restaurant environment for all guests by performing one or more ...

  • Abundant Blessings

    Data Support

    1 week ago

    Abundant Blessings Los Angeles, United States

    **Data Support / Quality Assurance Specialist - Homeless Services** · **ABUNDANT BLESSINGS** · **________________________________** · **Title: Data Support / Quality Assurance Specialist - Homeless Services** · **FLSA: Non-Exempt, Full-time** · **Supervisor: Operations Manager** ...

  • Creative Artists Agency (CAA)

    Human Resources

    1 week ago

    Creative Artists Agency (CAA) Los Angeles, United States

    Who We Are · Creative Artists Agency (CAA) is the leading entertainment and sports agency, with global expertise in filmed and live entertainment, digital media, publishing, sponsorship sales and endorsements, media finance, consumer investing, fashion, trademark licensing, and p ...

  • Kaiser

    Staff RN

    1 week ago

    Kaiser Los Angeles, United States Full time

    · $10,000 sign-on bonus for eligible external hires · Job Summary: · As the leader of the health care team, provides professional nursing care, utilizing the nursing process in accordance with established standards of care, policies, and procedures. Demonstrates performance cons ...

  • La Canada Unified School District

    Head Varsity Baseball Coach

    2 weeks ago

    La Canada Unified School District Los Angeles, United States

    Job Summary: · **Qualifications**: · 1. : Two years or more of successful experience coaching high school baseball and/or collegiate, professional or elite travel/club baseball. · 2. : Current first aid and CPR certifications. · **Salary**: The stipend for head coach is $3,871.96 ...