Senior Consultant, Quality and Compliance

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🕒 vor 25 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

🚔 Compliance

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Syner-G BioPharma Group

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Die Syner-G BioPharma Group ist der weltweit führende Anbieter von Lösungen in den Bereichen Chemie, Herstellung und Kontrolle (CMC), regulatorische Angelegenheiten und medizinisches Schreiben für den Biopharma-Sektor. Sie bieten umfassende Dienstleistungen, die Kunden durch die Komplexitäten der pharmazeutischen Entwicklung, regulatorische Einreichungen und Qualitätssicherung navigieren, um qualitativ hochwertige Ergebnisse sicherzustellen. Mit einem interdisziplinären Team integriert Syner-G wissenschaftliche, ingenieurtechnische und regulatorische Expertise, um die Arzneimittelentwicklung von der Vor-IND-Phase bis zur Phase nach der Zulassung zu unterstützen, was zeitgerechte Einreichungen und die Einhaltung der Patientensicherheit ermöglicht.

Beschreibung

• Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3) • Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, eCOA/ePRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs • Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start • Drive direction of the clinical quality function within client organizations — establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities • Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for-cause audits • Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections • Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure • Build and maintain audit programs (risk-based audit plans, annual schedules, audit metrics) for client sponsors • Review and approve clinical trial documents prior to use — protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports — for GCP compliance and inspection-readiness • Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on eTMF system configuration, indexing, and QC processes • Approve essential documents for clinical trial start-up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence • Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct • Author and approve CAPAs arising from audits, inspections, and quality events; ensure effectiveness checks are designed and executed • Advise client sponsors on quality issue escalation, including determination of reportability to regulatory authorities and IRBs/ECs • Provide quality input on regulatory submissions — IND, IMPD, CTA, NDA/BLA/MAA clinical modules — and represent the quality function during regulatory authority interactions • Lead client inspection support during FDA BIMO, EMA, MHRA, or other Health Authority inspections of sponsors, sites, or vendors • Maintain current knowledge of evolving GCP regulations and guidance (ICH E6(R3), ICH E8(R1), FDA decentralized clinical trial guidance, EU CTR, ICH E2A/E2B, 21 CFR Parts 11/50/54/56/312/812) and translate changes into actionable client recommendations • Independently manage multiple concurrent client engagements; serve as the senior quality point of contact and represent Syner-G at client governance and steering committee meetings • Expand existing accounts by identifying additional quality gaps and proposing scope extensions; support proposal development and SOW authorship for new GCP work • Contribute to Syner-G's GCP service offering — develop reusable templates, audit checklists, training content, and thought-leadership materials.

🎯 Anforderungen

• Bachelor's degree required in life sciences, chemistry, pharmacy, nursing, or related discipline • Advanced degree (MS, PharmD, PhD, or MPH) preferred • Professional certification valued: RQAP-GCP, SQA, ACRP-CP, or equivalent • Minimum 10 years of progressive experience in GxP-regulated environments, with at least 8 years of dedicated GCP experience in a sponsor, CRO, or consulting setting • Demonstrated experience as a lead clinical quality auditor across investigator sites, CROs, central labs, and clinical vendors — minimum 25 GCP audits led independently • Direct experience supporting at least one FDA BIMO inspection or equivalent EMA/MHRA GCP inspection of a sponsor or investigator site • Hands-on experience implementing and operating risk-based quality management (RBQM) programs aligned with ICH E6(R2) or E6(R3) • Experience across multiple clinical phases (Phase 1 through Phase 3 at minimum); Phase 4 / post-marketing surveillance experience valued • Experience supporting virtual or emerging biotech sponsors strongly preferred — including standing up clinical quality functions from scratch and operating with lean internal resources • Subject matter expertise in ICH E6(R2)/E6(R3), ICH E8(R1), ICH E9, and ICH E2A/E2B(R3) • Working command of 21 CFR Parts 11, 50, 54, 56, 312, and 812; EU Clinical Trials Regulation (EU 536/2014); EMA reflection papers on risk-based quality management and computerized systems • Fluency with eTMF systems (Veeva Vault Clinical, Phlexglobal, or equivalent), eCRF/EDC platforms (Medidata Rave, Veeva CDMS, or equivalent), CTMS, and IRT/RTSM platforms • Confident application of risk management methodology (ICH Q9(R1)) to clinical risk assessment, including critical-to-quality factor identification and quality tolerance limits.

🏖️ Vorteile

• market competitive base salary and annual incentive plan • robust benefit offerings • ongoing recognition and career development opportunities • generous flexible paid time off program • company paid holidays • flexible working hours • fully remote work options for most positions