• QA Regulatory Compliance Manager Jobs in United States Of America - 25363135

  • Abbott India Ltd
  • United States Of America, Usa
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines Our 103,000 colleagues serve people in more than 160 countries

The primary function of this position is to provide guidance, direction and strategic leadership in quality and regulatory compliance matters The Sr QA Regulatory Compliance Manager is responsible for establishing and implementing an internal audit program to effectively assess and report on the sites status relative to defined quality system requirements Primary responsibilities include planning activities needed to assess the status of the quality system, organizing resources appropriate to execute the identified plan, approving documentation as dictated by procedures and reporting status of key quality and compliance indicators to local and Divisional Management Supports the quality system by taking action to align the site to Divisional and Corporate objectives The incumbent facilitates inspections with regulatory agencies

Responsibilities

Assure compliance with the current Good Manufacturing Practices and all applicable standards and regulations
Monitor compliance with Divisional procedures and Corporate policies Manage all phases of external audits
Serve as Quality Systems Subject Matter Expert and Generalist/Escort
Establish program to promote a culture of Quality and Compliance
Maintain an Inspection Readiness Program with defined compliance enhancement activities
Maintain an effective Internal Audit Program aligned with Divisional schedule/improvement initiatives
Responsible for Document Control and Training areas
Assure Divisional procedures and Corporate policies related to document control and training are properly implemented and maintained
Gather and evaluate quality data for monthly CAB and quarterly Management Review Meetings Support sites continuous improvement initiatives
Identify and implement Cost Improvement Projects
Foster continuous improvement culture (ie lean, six sigma)
Additional responsibilities may include QA Release area, Microbiology Laboratory, Environmental Monitoring Program, Supplier Quality Engineering, among others (as assigned)

QUALIFICATIONS

Bachelor Degree Chemistry, Biology, Engineering or any other related science

Master Degree Desirable

The incumbent shall have good communications and negotiation skills which would allow assuring the resolution of compliance issues Also, should have a high degree of initiative, decision making and responsibility which will enable the incumbent to perform efficiently with a minimum supervision

Strong regulatory compliance and technical background, statistical knowledge and analytical skills are needed

Must possess excellent communication skills verbal and written in English, Spanish and regulatory language A solid knowledge of technical report writing and computer literate is required A minimum of ten (10) years experienced in a Quality or Technical field in the Medical Device/Pharmaceutical related business

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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