QA Regulatory Compliance Manager

Abbott in Menlo Park, CA

  • Type: Full Time
position filled
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 site's 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 site's continuous improvement initiatives.
+ Identify and implement Cost Improvement Projects.
+ Foster continuous improvement culture (i.e. 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.
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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-###-#### or email ...@abbott.com
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

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