Regulatory & Quality Leader, Oncology (GxP)
Pliant Therapeutics
Pliant Therapeutics, Inc. in South San Francisco, CA, seeks a dynamic Vice President of Regulatory Affairs & Quality (GxP) to lead global regulatory and quality oversight for an oncology portfolio. This senior leader role partners with the COO and executive team to design scalable GxP infrastructure supporting early-phase trials and potential late-stage development. The role requires deep regulatory and quality expertise, a track record with INDs/CTAs, and strong agency engagement. #J-18808-Ljbffr Pliant Therapeutics, Inc.
- Pliant Therapeutics is seeking a Vice President, Regulatory Affairs & Quality (GxP) to lead an integrated regulatory and quality function for an oncology portfolio, including Phase 1b assets. This hands-on leader will partner with FDA and global authorities, shape strategy...QualityRegulatory3 days per week
- ...Vice President, Regulatory Affairs & Quality (GxP) About the Company Clinical-stage biopharmaceutical company Industry Biotechnology... ...Specialties fibrosis integrins muscle biology oncology duchenne muscular dystrophy idiopathic pulmonary fibrosis...QualityRegulatory
$146.25k - $243.75k
Job title: Thought Leader Liaison Hematologic Oncology - Pacific CoastLocation: US / Remote / Remote USAbout... ...commercial compliance, legal and regulatory guidelines.KOL Engagement and Advocacy... ...wellbeing benefits including high-quality healthcare, prevention and wellness...QualityRegulatoryFull timeContract workWork experience placementWork at officeLocal areaRemote workHome office- Cytokinetics, Inc. is seeking a Manager of GxP Training, Quality Systems to lead the administration, development, and continuous improvement... ...maintain curricula and materials, and ensure compliance with regulatory requirements across multiple delivery formats. Reporting to...QualityRegulatory
$158.2k - $293.8k
...us Roche!The OpportunityThe PDQ Principal Quality Lead supports the Roche/Genentech... ...goals and initiatives, and management of regulatory authority inspections.Responsibilities and... ...Mentorship: Maintain expert knowledge of GxP regulations, company policies, and SOPs,...QualityRegulatoryFull timeLocal areaRelocation package- The Quality Assurance Leader at Kanvasbio will be responsible for implementing and scaling the quality function for our clinical-phase Live Biotherapeutic... ..., partnering with Manufacturing, QC, Facilities, and Regulatory Affairs to align systems and documentation with global...QualityRegulatory
- ...Therapeutics is seeking a Senior Director of Quality Systems and Compliance to craft and... ...with up to two remote days weekly, this leader will mature QMS, drive inspection readiness, and partner with Manufacturing, Regulatory, and Clinical QA to ensure patient safety...QualityRegulatoryRemote work
- ...from diseases of cardiac muscle dysfunction. The Manager of GxP Training, Quality Systems supports the administration, development, and... ...learning materials remain accurate, effective, and aligned with regulatory requirements, business needs, and established departmental...QualityRegulatoryContract work
- insitro is seeking a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations. You will own GMP/GCP quality, data integrity, and vendor quality at the intersection of outsourced development and AI-enabled...Quality
- Job Description Our client, a world leader in biotechnology and life sciences, is looking... ..., and compliance with GCP/ICH and regulatory requirements. Key Responsibilities Provideoperational... ...aligns with contracted scope,timelines, quality, and budget expectations. Contributeto...QualityRegulatoryLong term contract
- ...impact. We are committed to delivering high-quality, better-for-you products, and an... ...day. Position Summary: As Team Leader, you are responsible for the store’s overall... ...Follow company policies and all safety and regulatory standards · Promote a safe, secure...QualityRegulatorySummer workFlexible hoursShift workNight shift
$90 - $98 per hour
...Job Title: Global Clinical Trial Leader Location: South San Francisco, CA Type:... ...proactive risk mitigation to ensure high-quality study outcomes. Responsibilities Provide... ...of GCP/ICH requirements, international regulatory guidelines, and drug development...QualityRegulatoryContract workTemporary workLocal areaFlexible hours$200k - $247k
...employees, managers, and leaders to submit unsolicited... ...is a precision medicine oncology company committed to... ...Manufacturing Processes, Quality Assurance to join our IDEAYA... ...risk, and supporting regulatory readiness for complex,... ...(CDMOs), and other GxP service providers (vendors...QualityRegulatoryContract workTemporary workWork at officeLocal areaWork from home- ...Safety Physician to lead medical review and safety signal detection for its oncology portfolio. The role requires deep pharmacovigilance expertise, leadership experience, and global regulatory knowledge to guide safety decisions across trials and post-marketing activities...Regulatory
- ...expanding pipeline. The role will oversee medical affairs across oncology and immunology, driving scientific leadership, evidence... ...collaboration to maximize product value. The candidate will partner with Regulatory, Commercial, and Market Access, build a high-performing team,...Regulatory
$351k - $388k
Vice President, Regulatory Affairs and Quality (GxP) At Pliant, we believe differentiated science can make a meaningful... ...of programs, including our lead oncology program currently in Phase 1b. This is a hands‑on role for a leader who will own day‑to‑day global regulatory...QualityRegulatoryFull timeContract workFor contractorsFor subcontractorWork at office3 days per week- ALX Oncology is seeking a Clinical Trial Manager / Sr. CTM to drive global oncology trials from protocol through study completion... ...trials meet timeline and budget while maintaining high quality. Strong regulatory knowledge and TMF stewardship are required. Preferred...QualityRegulatory
- ...evolving industry. The Life Science Sector Leader is responsible for driving the strategic vision... ...design standards, best practices, and quality benchmarks for life science projects.Monitor industry trends and regulatory changes to ensure compliance and innovation....QualityRegulatory
$163k - $236k
...roadmap and drive execution of opportunities to compensate high quality youth creators maintaining high standards of safety and... ...help us navigate and innovate within an ever-changing global regulatory landscape, turning complex safety challenges into opportunities...QualityRegulatory$203k - $251k
...employees, managers, and leaders to submit unsolicited candidate... ...is a precision medicine oncology company committed to... ...engage cross‑functionally (Quality, CMC, Commercial, Regulatory, Accounting/Finance, IT),... ...end inventory management (GxP and SOX compliant) across...QualityRegulatoryContract workTemporary workWork at office- ...physician practices, creating a cohesive, quality-oriented clinical culture and... ...urology, gastroenterology, and radiation oncology) and offers numerous ancillary services,... ...with all applicable state statutory and regulatory requirements concerning CRNAs. Graduate...QualityRegulatoryHourly payDaily paidWork at office
- ...development and execution of hematology oncology therapeutics from preclinical through late... ...strategic planning, team leadership, regulatory submissions, and cross-functional collaboration... ...Ensure project delivery within quality, timeline, budget, and resource constraints...QualityRegulatory
$240k - $280k
...statistical leadership across ALX Oncology's clinical development... ...clinical studies that support regulatory submissions and advance innovative... ...activities, ensuring high-quality deliverables, effective... ...Strategic, collaborative leader with excellent communication,...QualityRegulatoryWork experience placementInterim roleWork at office$182.1k - $338.3k
...Maintain accountability for work product quality, timeliness, and budget, providing... ...down silos, interpret external legal and regulatory landscapes, and lead cross-functional projects... ...influence, coach, and advise teams and leaders to develop valuable solutions and...QualityRegulatoryFull timeLocal area- ...member to our group of talented Discipline Leaders. The ICT Discipline Leader (DL) is a... ...current with evolving codes, standards, and regulatory requirements and reflect updates in... ...ResponsibilitiesProvide technical leadership and quality oversight on project work.Serve as DPOR...QualityRegulatoryWork experience placementWork at officeRemote work
$127.5k - $236.9k
...closely with key stakeholders across Squads, Commercial functions, Quality, Compliance, and external partners to design and deliver high-... ...strict adherence to contractual terms, SLAs, compliance, and regulatory requirements in partnership with Legal, Healthcare Compliance...QualityRegulatoryFull timeContract workLocal areaRelocation package3 days per week- ...74Summary: We are seeking an experienced GxP Project Manager to lead and manage cross-... ...supporting pharmaceutical manufacturing, quality, laboratory, validation, and IT systems.... ...Quality, Manufacturing, Validation, IT, Regulatory Affairs, Engineering, and external vendors...QualityRegulatory
- ...study feasibility, start-up activities, risk assessments, and investigator meetings.Support quality management activities, including CAPAs, deviations, audits, and regulatory inspections.Drive continuous improvement initiatives, staff development, and medical training...QualityRegulatory
- ...collaboratively with the clinical leader, physician and members of the... ...demonstrated experience with oncology clinical trials.• Responsible... ..., KOLs and potentially regulatory meetings.• Lead efforts to author... ...ongoing basis to ensure data quality• Builds relationships with...QualityRegulatoryImmediate start
$250k - $311k
...operational strategy, delivery, quality, and cost of Xaira's clinical... ...being built, and requires a leader who is comfortable setting... ...health authority requests, and regulatory inspections.Define and... ...start-up through database lock.Oncology clinical operations experience...QualityRegulatoryFlexible hours
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