Current jobs related to Clinical Quality Director - Cambridge, Massachusetts - Alkeus Pharmaceuticals, Inc.

  • Clinical Trials Director

    3 weeks ago

    Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Director to lead the planning, implementation, and execution of global clinical trials. As a key member of our team, you will be responsible for managing clinical trials from start-up through close-out, ensuring that all components of the trial deliverables are executed to specified quality...

  • Senior Director of Quality Assurance

    4 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job Title: Senior Director, Quality AssurancePublicly Traded + Equity + Annual Bonus + HybridWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Why Choose Us?Competitive SalaryAnnual BonusEquityESPP401k ProgramMedical/Vision/DentalHybrid ScheduleJob Description:We are seeking a Senior Director of...

  • Senior Director of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our GMP suppliers.Key Responsibilities* Provide quality support and...

  • Associate Director, PV Quality

    3 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Associate Director, PV Quality to join our team. The successful candidate will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV Quality will lead the development of...

  • Director of Quality Operations

    3 weeks ago

    Cambridge, Massachusetts, United States Meet Full time

    Job Title: Director of Quality OperationsSummary:The Director of Quality Operations is responsible for overseeing commercial product distribution and maintaining Good Distribution Practices (GDP) for the US affiliate. This role manages third-party logistics providers, handles product release for distribution, and ensures compliance with GDP regulations and...

  • Associate Director, PV Quality

    3 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director, PV Quality to join our team. The successful candidate will be responsible for providing quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV...

  • Senior Director of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job DescriptionWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.As a Senior Director of Quality Assurance, you will provide quality oversight of our clinical development programs and manufacturing.Responsibilities:Provide quality support and guidance for our CMC programsPlan, conduct or facilitate...

  • Senior Director of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Publicly Traded Biotechnology Company seeks a Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. This is a hybrid position requiring 3 days per week on site. Responsibilities include:Providing quality support and guidance for our CMC programsPlanning, conducting, or facilitating supplier...

  • Senior Director of Quality Assurance

    4 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job OverviewWe are seeking a seasoned Senior Director of Quality Assurance to provide strategic quality oversight of our clinical development programs and manufacturing operations.This is a hybrid position requiring 3 days per week on-site at our facility.Key ResponsibilitiesProvide quality support and guidance for our CMC programsPlan, conduct, or...

  • Director of Quality Operations

    4 weeks ago

    Cambridge, Massachusetts, United States Meet Full time

    Job Title: Associate Director, Quality OperationsJob Summary:We are seeking an experienced Associate Director, Quality Operations to oversee commercial product distribution and maintain Good Distribution Practices (GDP) for our US affiliate. This role will manage third-party logistics providers, handle product release for distribution, and ensure compliance...

  • Associate Director, PV Quality

    4 weeks ago

    Cambridge, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers. The successful candidate will provide compliance support to the Moderna PV organization, establish and...

  • Senior Director of Quality Assurance

    3 weeks ago

    Cambridge, Massachusetts, United States Jobot Full time

    Job Summary:We are seeking a highly experienced Senior Director of Quality Assurance to provide quality oversight of our clinical development programs and manufacturing. The ideal candidate will have a strong background in biologics, specifically operational QA experience with monoclonal antibodies, and expertise in partnering with external manufacturers.Key...

  • Clinical Data Management Director

    4 weeks ago

    Cambridge, Massachusetts, United States Third Harmonic Bio Full time

    {"title": "Clinical Data Management Director", "description": "About Third Harmonic BioThird Harmonic Bio is a biopharmaceutical company dedicated to developing innovative treatments for severe allergy and inflammation. Our mission is to create a breakthrough treatment for people living with debilitating conditions that impact overall health and...

  • Quality Operations Director

    3 weeks ago

    Cambridge, Massachusetts, United States Vericel Corporation Full time

    Quality Operations DirectorVericel Corporation, a leader in advanced therapies, seeks a top performing Quality professional to join its commercial stage company. The successful candidate will oversee the Quality Assurance, Document Control, and Quality Supplier Management departments, ensuring compliance with regulations and industry standards.Key...

  • Director, Quality Assurance CMC

    4 weeks ago

    Cambridge, Massachusetts, United States Korro Bio, Inc. Full time

    About Korro Bio, Inc.Korro Bio, Inc. is a biopharmaceutical company pioneering the development of genetic medicines for rare and prevalent diseases using its proprietary RNA editing platform. Our mission is to harness the body's natural RNA editing process to deliver precise and transient single base edits, expanding the reach of genetic medicines and...

  • Senior Director of Quality Control

    4 weeks ago

    Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director of Quality Control to join our team in Cambridge, Massachusetts.Job Summary:The Senior Director of Quality Control will be responsible for leading the quality control organization at Beam's Massachusetts facility. This role will oversee the QC...

  • Senior Director of Clinical Operations

    3 weeks ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job DescriptionJob Title: Senior Director, Clinical OperationsCompany: Akebia TherapeuticsJob SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Clinical Operations to lead our clinical development programs. The successful candidate will have a strong background in clinical trial management, with a proven track record of delivering...

  • Clinical Systems QA Specialist

    3 weeks ago

    Cambridge, Massachusetts, United States Poxy Clinical, LLC Full time

    Job SummaryWe are seeking a highly skilled Clinical Systems QA Analyst to join our team at Poxy Clinical, LLC. As a key member of our team, you will be responsible for ensuring the quality and integrity of our clinical systems.Key ResponsibilitiesPerform quality reviews of User Requirements Specifications and Study ProtocolsCreate Test Scripts and other UAT...

  • Clinical Director

    4 weeks ago

    Cambridge, Massachusetts, United States Strong Force Staffing Full time

    About the JobClinical Director - Home HealthLocation: Cambridge, MassachusettsCompany: Strong Force Staffing (RPO for Client Agency)OverviewStrong Force Staffing is a leading recruitment process outsourcing firm dedicated to building stronger teams for a stronger tomorrow. We connect skilled professionals with dynamic employers, ensuring mutual growth and...

  • Medical Director

    3 weeks ago

    Cambridge, Massachusetts, United States Planet Pharma Full time

    Job SummaryPlanet Pharma is seeking a highly skilled Medical Director to provide clinical input to SAD/MAD studies. The ideal candidate will have industry and allergy experience, with a strong background in clinical settings.Key ResponsibilitiesProvide clinical input to SAD/MAD studiesHelp design and implement early POC studiesMedical monitoring of early POC...

Clinical Quality Director

2 months ago

Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full time
About Alkeus Pharmaceuticals

We are a late-stage biopharmaceutical company dedicated to developing transformative therapeutics for serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic Atrophy (GA) secondary to dry age-related macular degeneration.

Responsibilities
  • Manage GCP Quality Functional Area: Ensure compliance with US (FDA) and international regulations and guidance to protect clinical patients' rights, safety, and welfare.
  • Provide Quality Oversight: Ensure internal and external clinical functions comply with GCP, GLP, and relevant regulatory standards.
  • Act as GCP SME: Provide expertise on GCP and GVP compliance for clinical areas such as Clinical Operations, Pharmacovigilance, Data Management, etc.
  • Support Quality Management System SOPs: Draft and implement Alkeus GCP/GVP Quality Management System SOPs.
  • Manage Clinical Site and CRO/Vendor Audits: Plan and execute clinical site and CRO/Vendor audits.
  • Perform GCP Audits and Gap Assessments: Conduct external and internal GCP audits and gap assessments on an as-need basis.
  • Manage CAPA Closure: Manage clinical site, CRO/Vendor, and internal CAPA closure for audit observations.
  • Review Operational Plans and Protocols: Review clinical and data management operational plans and protocols.
  • Review Key Safety and Regulatory Documents: Review key safety, clinical, and regulatory documents, such as DSUR, IB, IND, and NDA.
  • Support Health Authority/Regulatory Inspections: Participate in preparing for, hosting, and supporting Health Authority/Regulatory inspections and internal/external audits.
  • Serve as SME for Regulatory Inspections: Serve as an SME for areas of responsibility during regulatory inspections and directly lead and/or support inspection Ready-Room activities.
  • Promote a Culture of Continuous Improvement: Promote a culture of continuous improvement and cross-functional problem-solving.
  • Stay Up-to-Date with Industry Developments: Keep abreast of industry developments, forthcoming regulations, guidance, best practices, etc.
  • Lead Risk-Based Quality Assessments: Lead the development of internal and external Risk-Based Quality Assessments.
  • Advise on Clinical Protocol Deviations: Advise on the severity and processing of clinical protocol deviations.
  • Perform Other Duties as Necessary: Perform other duties as necessary, demonstrating flexibility and adaptability.
Qualifications
  • Education and Experience: Bachelor's or Master's degree in a life science or healthcare field (Nursing, etc.) with 8 to 10 years of GCP experience in drug and/or biopharma companies or in a Contract Research Organization (CRO) capacity.
  • Experience with Small Molecule Drugs: Experience with small molecule drugs is a plus.
  • Self-Management and Communication Skills: Capacity to self-manage priorities and work independently while seeking guidance when necessary. Strong verbal and written communication and collaboration skills.
  • Quality Systems and Regulatory Knowledge: Demonstrated knowledge of Quality Systems, GCP, and PV within an FDA and EMA-regulated environment.
  • Ability to Work Independently: Ability to handle multiple assignments in a fast-paced environment with changing priorities and to influence and work independently in a team environment.
  • Compliance and Risk-Based Thinking: Ability to apply compliance and risk-based thinking to quality assessments and problem-solving.
  • Training and Mentoring: Demonstrated ability to train and mentor others in industry best practices.
Experience
  • Clinical Quality Systems Experience: 7+ years' experience with Clinical Quality Systems in the drug or biopharmaceutical fields.
  • GCP Auditing Experience: At least 3 years of prior GCP auditing experience of clinical sites, CRO's, and Pharmacovigilance required, with the ability to audit independently and deliver timely reports and assessments.
  • Implementation and Maintenance of Clinical Quality Systems: Experience in implementation and maintenance of Clinical Quality Systems.
  • Training Staff on GCP and GLP Principles: Experience in training staff on GCP and GLP principles, processes, and procedures.
  • Broad Experience in GCP/GVP Quality and Regulatory Compliance: Broad hands-on experience in GCP/GVP quality and regulatory compliance.
  • Excellent Knowledge of FDA GCP/GVP Regulations and Guidance: Excellent knowledge of FDA GCP/GVP Regulations and Guidance, ICH GCP/GVP Guidelines, EMA Directives and Regulations, and MHRA Regulations and Guidelines.
  • Thorough Understanding of Clinical Drug Development Processes: Thorough understanding of clinical drug development processes.
  • Auditing Clinical Study Sites: Auditing clinical study sites.
  • Assessing Compliance Status for GCP/GVP Databases: Assessing compliance status for GCP/GVP databases, such as for clinical data (EDC), PV, and eTMF systems.
  • Supporting Inspection-Readiness and Health/Regulatory Authority Inspections: Supporting inspection-readiness and Health/Regulatory Authority Inspections.
  • Supporting the Drafting, Quality Checks, and Source Data Verification of Regulatory Submissions: Supporting the drafting, quality checks, and source data verification of regulatory submissions is beneficial.
  • Experience in Monitoring Clinical Site Data: Experience in monitoring clinical site data is a plus.
  • Prior Experience with Small Molecule Oral Drugs: Prior experience with Small Molecule oral drugs is a plus.
  • Prior Relevant Experience at FDA (BIMO): Prior relevant experience at FDA (BIMO) as an investigator of Clinical Study Sites, Sponsors, GCP/GVP CROs, and Clinical Labs is a plus.
  • Fluent in English and Microsoft Applications: Fluent in English, with proficiency in Microsoft applications (Excel, Word, SharePoint, PowerPoint).
Travel
  • Willingness to Travel: Willingness to travel, up to 20%, on an as-need basis for performance of CRO, Vendor, or Clinical Site audits.