Senior Manager Global GMP Compliance

Recruiter
Clinical Professionals Ltd
Location
London (Greater)
Posted
31 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Manager Global GMP Compliance Location: Home Counties Salary: Negotiable/dependent on experience (Role will require 50% international travel) Duration: Permanent An exciting opportunity to join a Global Biologics company who are recruiting a Senior Manager Global GMP Compliance to develop, plan and execute a Global GMP Compliance program. You will also lead and manage global inspection readiness, remediation actions, Inspection management, inspection follow up and ensure compliance globally to regulatory and company expectations and guidelines. On top of this, you will also advise, guide and support sites worldwide on overall global regulatory inspection management. Responsibilities (to include, but not limited to): *Develop inspection/audit plans and agendas for corporate GMP Compliance assessments based on risk taking into account current regulatory standards and business needs. *Execute corporate GMP Compliance assessments/audits as part of the Global GMP Compliance Department. *Advise, guide and support sites in the overall regulatory inspection management process. *Provide advice and on-site support to sites during regulatory inspections as required. *Provide expertise to sites and the organisation on new and developing GMP regulatory requirements and trends, to ensure the company remains up to date with cGMP. *Continually develop, mentor, train and enforce a Global GMP culture. *Participate in the continuous improvement and maintenance of a global platform for reporting, reviewing and trending GMP compliance risks on a global basis. *Advise and support sites in devising and executing remediation actions to ensure compliance to regulatory and company requirements. Experience required: *Life Science degree (ideally in Biology, Chemistry or Pharmacy) at Bachelor's level preferably supported by PhD, MSc or MBA. *5+ years' experience as a GMP auditor. *Over 5 years' experience in international regulatory inspection management including the MHRA and FDA. *10 years Quality Assurance experience which encompasses cGMP and Quality Systems exposure. If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place. Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion. Qualified person, GXP, GMP, GDP, Qualified Person, 2001/83/EC, Audit, Auditor, R&D, Generics, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties,

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