Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

PV QA Strategy Director - Global Quality & REMS Oversight

$184.24k - $276.36k

Initial Therapeutics, Inc.

Initial Therapeutics, Inc. is seeking a Director, PV QA DSI to lead the Quality Assurance strategy within Clinical Safety and Pharmacovigilance (CSPV). This role will oversee PV QA activities, ensuring compliance with regulatory requirements while leading a high-performing team. Candidates should have 10+ years of experience in PV QA and strong knowledge of international regulations, as well as the ability to foster a culture of excellence. The position offers competitive compensation, with a salary range of USD$184,240.00 - USD$276,360.00. The ideal candidate will have a proven record of leadership and innovative problem-solving skills. #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the PV QA Strategy Director - Global Quality & REMS Oversight in Basking Ridge, NJ vacancy
  • Daiichi Sankyo, Inc. in Basking Ridge, NJ seeks a Head of Quality Assurance to oversee the quality oversight of internal sites and CDMO. This role is responsible for managing QA functions, ensuring compliance with global standards, and driving continuous improvements. The... 
    Quality

    Merck & Co. Inc

    Basking Ridge, NJ
    2 days ago
  • $184.24k - $276.36k

    Job Title: Director, PV QA DSI Job Requisition ID: 1732...  ...to "be an innovative global healthcare company...  ...implementation of the Quality Assurance strategy within the Clinical...  ...in place for quality oversight of Daiichi Sankyo...  ...marketed products under REMS program in... 
    Quality
    Local area

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    2 days ago
  • Merck & Co. seeks a Quality Assurance professional to oversee contract manufacturing organizations...  ...and knowledge in drug manufacturing and QA compliance. This position is poised for...  ...a collaborative environment, supporting global operations with potential travel requirements... 
    Quality
    Contract work

    Merck & Co. Inc

    Basking Ridge, NJ
    2 days ago
  • Initial Therapeutics, Inc. is seeking a Head of Quality Assurance to oversee the quality processes at internal sites and Contract Development...  ..., extensive audit readiness, and expertise in managing global teams. The position also offers significant influence in promoting... 
    Quality
    Contract work

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    1 day ago
  • $226.28k - $377.13k

    Job Summary The Head of Quality Assurance, Drug Product...  ...for the quality oversight of internal sites and Contract...  ...Chain, Tech Unit and global Quality leaders to assure...  ...overseeing QA functions, including final...  ...implementing proactive mitigation strategies to ensure patient... 
    Quality
    Contract work

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    1 day ago
  • EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal... 
    Quality

    EmergencyMD

    Convent Station, NJ
    1 day ago
  • $83.71k - $109.87k

    Legend Biotech US, based in Raritan, NJ, is seeking a QA Lab Compliance Specialist III to provide oversight of Quality Control Laboratories. This role involves ensuring compliance with global standards and supporting regulatory inspections and audits. Candidates must hold... 
    Quality

    Legend Biotech US

    Raritan, NJ
    4 days ago
  • Initial Therapeutics, Inc. is hiring for a QA management role focusing on ensuring compliance within contract manufacturing operations. The role involves oversight of Quality Management Systems, partnering with quality leaders, and supporting validation efforts for drug... 
    Quality
    Contract work

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    2 days ago
  • $120k - $150k

    Shionogi Inc. (U.S.) in Florham Park, NJ, is seeking a QA Product Manager to ensure quality and compliance of sterile pharmaceutical products. The ideal candidate will have at least five years of pharmaceutical Quality Assurance experience, lead technology transfer projects... 
    Quality

    Shionogi Inc. (U.S.)

    Florham Park, NJ
    5 days ago
  • $61.45k - $80.66k

    Legend Biotech is a global biotechnology company dedicated to treating, and one day curing...  ...therapeutics for patients worldwide. QA Investigations Lead I Location: Raritan,...  ...Lead is responsible for providing quality oversight and guidance during the investigation of... 
    Quality
    Full time
    Temporary work
    Work experience placement
    Worldwide
    Flexible hours

    Legend Biotech

    Raritan, NJ
    4 days ago
  • Scorpion Therapeutics is seeking a Senior Director for Device Quality to provide strategic leadership for quality across medical...  ...systems. This role involves leading Device Quality strategy, ensuring compliance with global device regulations, and improving quality systems... 
    Quality

    Scorpion Therapeutics

    Madison, NJ
    5 days ago
  •  ...Job Title: QA Director Job ID: 2024-13197 Job Location: Omaha, NE, Berkeley Heights, NJ (100% Onsite – local only no relocation) Job Travel...  ...and coach 4 direct reports and 36 indirect reports. Drive Quality Practices and Standards across the Organization Champion the culture... 
    Quality
    Permanent employment
    Local area
    Relocation

    Highbrow

    Berkeley Heights, NJ
    3 days ago
  • $156k - $234k

     ...of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right...  ...develop and implement our global supply strategy, or work with our Procurement Centre of Excellence... 
    Quality
    Contract work
    Temporary work
    Local area
    Shift work

    Reckitt

    Parsippany, NJ
    4 days ago
  • $70k - $80k

    ## Quality Assurance Business Analyst Supervisor - Contact Center...  ....The role is responsible for oversight of QAA performance, quality scoring...  ...own the design of monitoring strategy, thresholds, or reporting...  ....IQVIA is a leading global provider of clinical research... 
    Quality
    Full time
    Part time
    Immediate start
    Worldwide

    IQVIA

    New Providence, NJ
    3 days ago
  • $255k - $425k

     ...Job Title: Executive Director, Head of Clinical Supply...  ...to "be an innovative global healthcare company contributing...  ...Business Unit (OBU), Quality & Safety Management,...  ..., governance and oversight of all clinical supply...  ...objectives. Leads the strategy for Global CSO, which... 
    Quality
    Temporary work

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    1 day ago
  • $201.84k - $302.76k

     ...provides strategic direction for and oversight of the Risk Based Quality Management (RBQM) principles that...  .... Responsibilities RBQM Vision and Strategy: Provides strategy and leads implementation...  ...impacted Daiichi Sankyo functions globally and with external parties as... 
    Quality

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    5 days ago
  • $45 - $59 per hour

     ...Job Title QA Product Manager (Sterile Products) Location Florham Park, New Jersey Type...  ...with contract manufacturers to resolve quality issues, monitor compliance, and ensure product...  ...in sterile drug product manufacturing/oversight. Strong background in batch record review... 
    Quality
    Hourly pay
    Ongoing contract
    Contract work
    For contractors
    Zero hours contract
    Local area
    Remote work

    System One

    Florham Park, NJ
    1 day ago
  •  ...The E2E QA Lead position seeks a highly motivated and experienced...  ...and implementing E2E QA strategies, driving automated test suite...  ...information, please review Insight Global's Workforce Privacy Policy:...  ...related field. - 7+ years in Quality Assurance. - 3+ years leading... 
    Quality

    Insight Global

    Parsippany, NJ
    5 days ago
  • $127.28k - $190.92k

     ...serves as a subject matter expert for the oversight, guidance, and design of study build...  ...and user acceptance testing, and managing quality deliverables in partnership with RAVE Administrator...  ..., management, and advancement of DS Global Library Standards. This position will... 
    Quality

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    2 days ago
  • $120k - $150k

     ...QA Product Manager The QA Product Manager is responsible for ensuring the quality and compliance of pharmaceutical products (active pharmaceutical...  ...teams (regional and global), including external...  ...effective contamination control strategies, and maintain adherence to... 
    Quality
    Full time
    Contract work
    For contractors
    Work at office
    Local area

    Shionogi Inc.

    Florham Park, NJ
    3 days ago
  • $120k - $150k

     ...Overview The QA Product Manager (Sterile Products) plays a critical role in ensuring the quality, safety, and regulatory compliance of sterile...  ...cross-functionally with global internal teams and external...  ...assurance and contamination control strategies, and uphold regulatory... 
    Quality
    Full time
    Work at office
    Local area

    Shionogi Inc.

    Florham Park, NJ
    1 day ago
  • $184.24k - $276.36k

    Job Summary The Director, Regulatory Affairs Advertising and Promotion...  ...for leading regulatory strategy and decision‑making for complex...  ...complex issues with limited oversight, escalating only the most significant...  ...to improve review quality, efficiency, transparency, and... 
    Quality
    Work at office

    Initial Therapeutics, Inc.

    Basking Ridge, NJ
    2 days ago
  •  ...Overview Customer Quality member responsible for supporting Post Market Regulatory Affairs...  ...Specialist is responsible for the oversight and direct support of technical evaluations...  ...Report Knowledge of and familiarity with global regulations for reporting Directly interface... 
    Quality
    Work experience placement

    LanceSoft

    Raritan, NJ
    1 day ago
  •  ...management planning and strategy, and execution of...  ...ensuring compliance with global regulatory requirements...  ...milestones with appropriate oversight. Author responses for...  ...contribute to specified PV sections of the...  ...to manage timelines and quality of work using organizational... 
    Quality
    Worldwide

    TechDigital Group

    Madison, NJ
    5 days ago
  • $158.14k - $194.47k

     ...Director, Quality Control As a privately-owned, biopharmaceutical...  ...leadership and oversight of the Quality Control...  ...Technical Operations, QA, and CMC Regulatory Affairs...  ...managing FDA and global regulatory inspections...  ...LIMS. Leadership & Strategy: Demonstrated ability... 
    Quality
    Full time
    Contract work
    Temporary work
    Local area
    Flexible hours

    Ferring International Center

    Parsippany, NJ
    3 days ago
  • Legend Biotech USA is seeking a QA Laboratory Compliance Specialist III based in Raritan, NJ. This role involves providing quality and compliance oversight for testing Advanced therapy products in collaboration with various Quality Control departments. The ideal candidate... 
    Quality

    Legend Biotech

    Raritan, NJ
    4 days ago
  • Legend Biotech, located in Raritan, NJ, is seeking a QA Laboratory Compliance Specialist III to oversee quality control laboratories and ensure all practices comply with global regulatory requirements. The ideal candidate will have at least 2 years of relevant experience... 
    Quality

    Merck & Co. Inc

    Raritan, NJ
    5 days ago
  • Merck & Co. is looking for a Senior Director, Clinical Safety Science, to shape and advance global safety strategy throughout the product lifecycle. This leadership role oversees a team of Safety Scientists, ensuring proactive safety surveillance and risk mitigation. The... 

    Merck & Co.

    Basking Ridge, NJ
    3 days ago
  • $242.7k - $404.5k

    Daiichi Sankyo US is looking for a Senior Director, Clinical Safety Science to lead global safety strategy across the product lifecycle. This key role oversees a team of Safety Scientists and collaborates with various stakeholders for proactive safety surveillance and... 

    Daiichi Sankyo US

    Basking Ridge, NJ
    2 days ago
  • Legend Biotech in Raritan, NJ is seeking a QA Investigations Lead I to provide quality oversight for personalized cell therapy production in a GMP environment. The ideal candidate will demonstrate excellence in quality, collaborate with various teams, and handle investigations... 
    Quality

    Dormont Manufacturing Company

    Raritan, NJ
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to PV QA Strategy Director - Global Quality & REMS Oversight. Be the first to apply!