Talent.com
Director – Quality GCP
Director ‚Äì Quality GCPScorpion Therapeutics • Boston, MA, United States
[error_messages.no_longer_accepting]
Director – Quality GCP

Director – Quality GCP

Scorpion Therapeutics • Boston, MA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too!Try it now — JobsAI.

Role Summary

Director Quality GCP responsible for strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs. Requires 75% on-site presence and collaboration with teams in Boston and Basel.

Responsibilities

  • Primary GCP Quality contact for identified vendors and investigator sites supporting clinical programs and other GCP quality events (e.g., potential serious breach assessments, CAPAs).
  • Author key GCP quality SOPs and serve as reviewer for other quality (GxP) procedures.
  • Develop a risk-based GCP compliance program.
  • Support initiation, review, and closure of quality events and associated CAPA, Change Action, and Effectiveness plans.
  • Develop and provide GCP and other GxP training as applicable.
  • Ensure appropriate qualification of vendors and compliant vendor management with regular assessments / audits; may conduct GCP audits (vendors and sites).
  • Ensure audit observations are communicated, tracked, and remediated.
  • Provide QA GCP review and feedback on regulatory submissions.
  • Lead and participate in inspection readiness activities for regulatory inspections internally and at clinical sites.
  • Interface with internal departments and external vendors on technical / quality subjects.

Qualifications

  • BS Degree in Chemistry, Pharmacy, Biology or a related life science, or combination of BS Degree with relevant Quality and Technical experience.
  • Minimum of 16 years of experience within the pharmaceutical or biopharmaceutical industry, with development experience and exposure to commercial operations.
  • Knowledge and experience of clinical and commercial systems supporting GCP compliance with US and global regulations (FDA, EMA, ICH, MHRA, etc.). GLP experience is a plus.
  • Able to provide a solution-minded approach and flexibility to emerging challenges.
  • Able to balance priorities and multi-task against competing demands.
  • Proven ability to work in a fast-paced, matrixed, start-up environment.
  • Hands-on leadership with a practical, solution-focused mindset.
  • Understanding of drug development and program management is preferred.

    • Skills

  • GCP and GxP quality management
  • Vendor qualification and audit management
  • Regulatory submissions support and inspection readiness
  • Risk-based compliance program development
  • Training program development and delivery
  • Cross-functional collaboration in a matrixed environment

    • Education

  • BS in Chemistry, Pharmacy, Biology or related life science (or equivalent combination with relevant quality experience)

    • #J-18808-Ljbffr

    [job_alerts.create_a_job]

    Director Quality • Boston, MA, United States

    [internal_linking.similar_jobs]
    Director, Quality Assurance

    Director, Quality Assurance

    IMMUNEERING CORPORATION • Cambridge, MA, US
    [job_card.full_time]
    Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease.Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in pat...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director, Clinical & Safety Quality Compliance

    Senior Director, Clinical & Safety Quality Compliance

    Takeda Pharmaceuticals • Boston, MA, United States
    [job_card.full_time]
    A leading pharmaceutical company in Boston is seeking an Associate Director for Clinical and Safety Quality Compliance.The role involves ensuring compliance with quality standards and regulations, ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director / Sr. Director, Quality Systems and GxP Compliance

    Director / Sr. Director, Quality Systems and GxP Compliance

    Scholar Rock • Cambridge, MA, US
    [job_card.full_time]
    Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biolo...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of Quality Control

    Director of Quality Control

    Vivid Resourcing • Cambridge, MA, US
    [job_card.full_time]
    Director, Quality Control (QC).An innovative biotechnology company developing next-generation biologics and engineered fusion protein therapeutics focused on immune and autoimmune-driven diseases i...[show_more]
    [last_updated.last_updated_1_hour] • [promoted] • [new]
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    Eisai • Andover, MA, United States
    [job_card.full_time]
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Clinical and Preclinical Quality Director

    Clinical and Preclinical Quality Director

    Artbio • Cambridge, Massachusetts, United States, 02138
    [job_card.full_time]
    Clinical and Preclinical Quality Director.The Clinical and Preclinical Quality Director (CQD) will lead the development, implementation, and communication of high-quality standards to ensure the de...[show_more]
    [last_updated.last_updated_variable_days]
    Director of Quality Assurance

    Director of Quality Assurance

    Childrens Services Of Roxbury • Roxbury, MA, US
    [job_card.full_time]
    The Quality Assurance Director leads quality assurance, compliance, and training oversight across the Behavioral Health Department. This leadership role ensures CSR’s behavioral health program...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Clinical and Preclinical Quality Director

    Clinical and Preclinical Quality Director

    ARTBIO • Cambridge, MA, US
    [job_card.full_time]
    The Clinical and Preclinical Quality Director (CQD) will lead the development, implementation, and communication of high-quality standards to ensure the delivery of global clinical studies.With a f...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Associate Director, GMP Operational Quality (Hybrid)

    Associate Director, GMP Operational Quality (Hybrid)

    Vertex • Boston, MA, US
    [job_card.full_time]
    The Associate Director is recognized as an expert in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring ali...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Quality & Equity MassHealth

    Director, Quality & Equity MassHealth

    InsideHigherEd • North Quincy, Massachusetts, United States
    [job_card.full_time] +1
    The Director of Quality and Equity for MassHealth supports the Office of Clinical Affairs and MassHealth teams in the development and implementation of quality and equity programs including a broad...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Quality Operations, Commercial Manufacturing – Cell & Gene Therapy

    Director, Quality Operations, Commercial Manufacturing – Cell & Gene Therapy

    Vertex Pharmaceuticals • Boston, MA, United States
    [job_card.full_time]
    Director, Quality Operations, Commercial Manufacturing – Cell & Gene Therapy.Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.The Director, GMP Operati...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Director

    Quality Director

    JLL • Boston, MA, US
    [job_card.full_time]
    JLL empowers you to shape a brighter way.Our people at JLL and JLL Technologies are shaping the future of real estate for a better world by combining world class services, advisory and technology f...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Quality and Regulatory Affairs Director (Cambridge)

    Quality and Regulatory Affairs Director (Cambridge)

    Aspire Life Sciences Search • Cambridge, MA, United States
    [job_card.full_time]
    Our client is a fast-growing MedTech start-up based in Boston, developing next-generation ophthalmology devices.With clinical milestones progressing, FDA interactions underway, and an ambitious com...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Manager / Associate Director, Quality Control (QC) / Analytical Development (AD)

    Senior Manager / Associate Director, Quality Control (QC) / Analytical Development (AD)

    Merida Biosciences • Cambridge, MA, US
    [job_card.full_time]
    Senior Manager / Associate Director, Quality Control (QC) / Analytical Development (AD).At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases.We specifically ta...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Audits, Inspections, & QMS

    Senior Director, Audits, Inspections, & QMS

    Alnylam Pharmaceuticals • Cambridge, MA, United States
    [job_card.full_time]
    Reporting to the SVP, Head of Quality Assurance & Quality Control, this is an enterprise leadership role and is responsible for providing strategic and operational leadership in the planning and ex...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of Safety and Quality

    Director of Safety and Quality

    Merlin Labs • Boston, MA, US
    [job_card.full_time]
    Merlin is a venture backed aerospace startup building a non-human pilot to enable both reduced crew and uncrewed flight.Backed by some of the world’s leading investors, Merlin is scaling alon...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Director, Quality & Equity MassHealth

    Director, Quality & Equity MassHealth

    UMass Med School • North Quincy, MA, United States
    [job_card.full_time] +1
    Director, Quality & Equity MassHealth.Non Union Position -W60- Non Unit Professional.The Director of Quality and Equity for MassHealth supports the Office of Clinical Affairs and MassHealth teams i...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Global Evidence & Outcomes

    Director, Global Evidence & Outcomes

    Takeda • Boston, MA, United States
    [job_card.full_time]
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]