Talent.com
Associate Director, Global Product Quality - GMP Processes
Associate Director, Global Product Quality - GMP ProcessesOtsuka Pharmaceutical • Princeton, New Jersey, US
[error_messages.no_longer_accepting]
Associate Director, Global Product Quality - GMP Processes

Associate Director, Global Product Quality - GMP Processes

Otsuka Pharmaceutical • Princeton, New Jersey, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Summary

The Associate Director, Global Product Quality – GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization. This role defines, maintains continuously improves critical quality system elements including Product Quality Complaints (PQC), Corrective and Preventive Actions (CAPA), Deviations, and Change Control , ensuring compliance with global regulatory requirements and internal standards. The successful candidate will lead cross-functional initiatives to enhance quality performance, reduce risk, and foster a culture of continuous improvement.

Key Responsibilities

  • Process Ownership & Governance :

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Lead the global strategy and governance for Product Quality Complaints, CAPA, Deviations, and Change Control processes. Develop and implement global standards, procedures, and best practices to ensure consistency and compliance across all global affiliates. Partner with regional and site quality leaders to drive process improvements, enhance efficiency, and ensure alignment with corporate quality objectives

  • Cross-functional Leadership :

    • Collaborate with Regulatory Affairs, Technical Operations, Manufacturing, and Supply Chain to ensure alignment and integration of quality into product lifecycle activities.

  • Quality Strategy Development :

    • Lead or support global projects related to digital transformation, system upgrades, and process optimization.

  • Inspection Readiness & Compliance :

    • Support regulatory inspections and internal audits, ensuring readiness and robust documentation of quality system performance.

  • Metrics and Reporting :

    • Monitor and report on key performance indicators (KPIs) to senior leadership, identifying opportunities for improvement and risk mitigation.

  • Training & Change Management :

    • Provide leadership, coaching, and subject matter expertise to global teams on GMP compliance and quality system execution.

    Qualifications

    Required

  • Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (Master’s or PhD preferred).
  • 8+ years of experience in pharmaceutical quality, regulatory affairs, or technical operations.
  • Proven expertise in managing and optimizing PQC, CAPA, deviation, and change control systems.
  • Experience leading cross-functional teams and global projects.
  • Skills & Competencies :
  • Strong knowledge of GMP, ICH guidelines, and global regulatory requirements.
  • Strong analytical skills with experience in quality metrics, risk management, and root cause analysis.
  • Excellent project management, communication, and stakeholder engagement skills.
  • Strategic thinker with a continuous improvement mindset.
  • Proficiency in quality systems and digital tools (e.g., TrackWise, Veeva).

    • Preferred Experience :

  • Certification in Lean, Six Sigma, or Quality Auditing. xklufbp
  • Experience in global matrix organizations and cross-cultural collaboration.
  • Knowledge of digital transformation in quality processes
    • [job_alerts.create_a_job]

    Director Global Quality • Princeton, New Jersey, US

    [internal_linking.related_jobs]
    Associate Consultant - R&D Advisory - US

    Associate Consultant - R&D Advisory - US

    Syneos Health / inVentiv Health Commercial LLC • Bridgewater, NJ, United States
    [job_card.full_time]
    You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and come out on top. In this role, you'll join the R&D Advisory Group wi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Cath Lab Tech in Browns Mills, New Jersey - $3,511 / week

    Cath Lab Tech in Browns Mills, New Jersey - $3,511 / week

    VETTED • Browns Mills, NJ, United States
    [job_card.full_time]
    Vetted is seeking a Cath Lab Tech for a travel job in Browns Mills, New Jersey.The job was posted about 1 month ago.The assignment starts on ASAP and is 13 weeks long with 8 hour shifts 5 days a we...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Campaign Operations

    Associate Director, Campaign Operations

    Dow Jones & Company • Princeton, New Jersey, USA
    [job_card.full_time]
    The Associate Director position is responsible for executing comprehensive campaign strategies for Dow Jones.You will lead a team in designing and implementing effective website and ecommerce progr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Control Associate

    Quality Control Associate

    Careers at RK Pharma Inc. • Hightstown, NJ, US
    [job_card.full_time]
    RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking an Quality Control Associate to work with our growing Quality Control Team as we scale towards commerci...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Launch Project Management

    Associate Director, Launch Project Management

    Sandoz • Princeton, New Jersey, USA
    [job_card.full_time]
    The Associate Director Launch Project Management leads and executes launch activities to bring Generics and Biosimilars products to market on time with defined launch quantities and a coordinated c...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Clinical Quality Associate

    Clinical Quality Associate

    GForce Life Sciences • Princeton, NJ, US
    [job_card.temporary]
    Hybrid in Princeton, NJ - onsite on Wednesday.Shadow and support quality oversight activities for 10+ ongoing clinical studies (from planning to reporting stages), ensuring best practices are ident...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director / Director of Drug Safety

    Associate Director / Director of Drug Safety

    Systimmune • Princeton, NJ, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its establi...[show_more]
    [last_updated.last_updated_30]
    Clinical Supplies Associate

    Clinical Supplies Associate

    Joulé • Basking Ridge, NJ, US
    [job_card.temporary]
    Title : Clinical Supplies Associate Location : Basking Ridge, NJ (Hybrid; onsite 2 days per week) Type : 12 Month Contract Schedule : M-F Day Pay : $30-34 / hour Responsibilities : Monitor and assess tempe...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Lead Associate, Quality Audits

    Lead Associate, Quality Audits

    Dr Reddy's Laboratories Limited • Princeton, NJ, US
    [job_card.permanent]
    Reddy's "Good Health Can't Wait".Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering i...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Remote Product Tester – $45 / hr + Free Products – Start Now!

    Remote Product Tester – $45 / hr + Free Products – Start Now!

    OCPA • Westampton, New Jersey, us
    [filters.remote]
    [job_card.part_time] +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, Product Management

    Associate Director, Product Management

    Generate Biomedicines • Somerville, New Jersey, USA
    [job_card.full_time]
    Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning biological engineering and medicine pioneering Generative Biology to create breakthrou...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    ??????? -??-??????

    ??????? -??-??????

    Hengrui Pharma • Princeton, NJ, US
    [job_card.full_time]
    GLP(???????)??????????????????,????????????????.DoE(????)?????,?????????????(JMP / Minitab?)?.Responsible for upstream / downstream biopharmaceutical process development and optimization (including but...[show_more]
    [last_updated.last_updated_30] • [promoted]
    GMP Quality Associate Director

    GMP Quality Associate Director

    VirtualVocations • Hamilton, New Jersey, United States
    [job_card.full_time]
    A company is looking for an Associate Director, Global Product Quality - GMP Processes.Key Responsibilities Lead global strategy and governance for Product Quality Complaints, CAPA, Deviations, a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Vice President of Technology Services

    Associate Vice President of Technology Services

    InsideHigherEd • Branchburg, New Jersey, United States
    [job_card.full_time]
    About Raritan Valley Community College : .New Jersey, Raritan Valley Community College has been serving as an academic and cultural center for Somerset and Hunterdon County residents for over 50 year...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Omnichannel Strategy & Execution

    Director, Omnichannel Strategy & Execution

    Keenova • Bridgewater, NJ, US
    [job_card.full_time]
    The Director, Omnichannel Marketing, leads the design and execution of integrated HCP and patient engagement strategies across all channels. This role shapes the overall omnichannel vision — driving...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Product Quality - GMP Processes

    Associate Director, Global Product Quality - GMP Processes

    Otsuka Pharmaceutical • Princeton, New Jersey, United States
    [job_card.full_time]
    The Associate Director, Global Product Quality – GMP Process is responsible for enabling the optimization and harmonization of key GMP quality practices across the global organization.This role def...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, Global Regulatory Affairs Diagnostics

    Associate Director, Global Regulatory Affairs Diagnostics

    J&J Family of Companies • Raritan, NJ, US
    [job_card.full_time]
    Job Title : Associate Director, Global Regulatory Affairs Diagnostics.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where c...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Cath Lab Tech - $3,265 to $3,458 per week in Browns Mills, NJ

    Travel Cath Lab Tech - $3,265 to $3,458 per week in Browns Mills, NJ

    AlliedTravelCareers • Browns Mills, NJ, US
    [job_card.full_time] +1
    AlliedTravelCareers is working with Aya Healthcare to find a qualified Cath Lab Tech in Browns Mills, New Jersey, 08015!. Aya Healthcare has an immediate opening for the following position : .Cath Lab...[show_more]
    [last_updated.last_updated_30] • [promoted]