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Senior Quality Manager/Associate Director. GCP. United States - Oferta z Jobs.pl

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Senior Quality Manager/Associate Director. GCP. United States

Nr ref.: /JOBS.pl

  • Senior Quality Manager/Associate Director. GCP (Good Clinical Practice)

    Clinical Research Operations. United States. East Coast

    Required Experience:

    GCP (Good Clinical Practice) Auditing experience: 5+ Years. Lead Auditor / Senior Auditor
    Clinical Quality Systems Experience. Including; Vendor Management.
    Responsibility for the oversight of the GCP Auditing operations and company auditing partners
    Operational role - Hands On. Exciting fast paced and fast growing clinical research company
    Office Based - East Coast. Part home based flexibility

    Ongoing suppport/training and development will be provided to undertake GvP Pharmacovigilance Auditing

    Competitive base salary
    Bonus Scheme and associated benefits
    Relocation Assistance Payment


    This is an exceptional opportunity for an experienced and senior level industry GCP clinical research auditor to join an exciting fast growth company. My client is involved in mutiple ongoing clinical studies with progressing developments within its specialist fields of research. As a result of continued business development and upscale across departments, they now also seek a proven senior/lead experienced industry GCP Auditor to join their Clinical Operations division.

    This challenging and exciting Manager / Associate Director level role will be hands on and requires strong operational abilities. Your dual responsibilities will include undertaking on average 2 GCP audits per month, plus responsibility for the oversight of the GCP Auditing operations and company auditing partners.

    You will be able to demostrate solid Clinical Quality Systems Experience, Including experience in Vendor Management.

    Additional Duties / Responsibilities:

    This is dual responsibility position - Working both operational and hands on office based, and also as a solo / lead GCP (Good Clinical Practice) auditor - Underatking on average 2 audits a month in the US and Global as required.

    You will play a key role in the implementation, oversight and ongoing maintenance of all internal and external Clinical Quality Systems and support to investigator sites, CRO's etc. plus involvement in the company's clinical development programs. Other responsibilities will include the management of GCP (Good Clinical Practice) and GvP (Pharmacovigilance) Quality Systems - ensuring the company and all outsourced partners (CRO's, Investigator Sites etc.) are always audit ready.

    On Offer:

    My client offers an excellent and highly competitive start base salary, together with a competitive bonus structure and company benefits. Relocation assistance is also on offer.

    Qualifications Required / Experience Level:

    · Bachelor's Degree or higher. BSc / PhD / MD
    · 4+ Years Clinical Quality Systems Experience within Industry direct
    · 5+ Years GCP (Good Clinical Practice) Solo / Lead / Senior Auditing experience
    · Experience in the implementation / maintenance of Clinical Quality Systems
    · Experience across cGxPs within FDA and EMA regulatory
    · Self-starter, Hands On, Opertaional and Motivated. Able to manage multiple tasks and deadlines
    · Strong team ethics, negotiation and time management skills
    · Able to travel - Nationally and International as required without restictions. Circa 30% of time
    · Eligible to live and work in the United States. East Coast
    · Solid knowledge of European / International regulatory requirements + Industry guidelines governing GCP / PV / GLP - ICH, EMA and FDA

    Apply today to this exciting and challenging Senior Quality Manager / Associate Director. (GCP) Good Clinical Practice position.

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