Senior Consultant, Quality and Compliance

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🕒 il y a 1 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

🚔 Conformité

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Syner-G BioPharma Group

Site WebLinkedInTous les Emplois

201 - 500 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syner-G BioPharma Group est le leader mondial dans la fourniture de solutions en chimie, fabrication et contrôles (CMC), affaires réglementaires, et rédaction médicale pour le secteur biopharmaceutique. Ils offrent des services complets qui guident les clients à travers les complexités du développement pharmaceutique, des soumissions réglementaires, et de la conformité qualité, assurant des résultats de haute qualité. Avec une équipe multidisciplinaire, Syner-G intègre la science, l'ingénierie et l'expertise réglementaire pour soutenir le développement de médicaments depuis les phases pré-IND jusqu'à la post-approbation, permettant des soumissions en temps opportun et une adhésion à la sécurité des patients.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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