Manager of Compliance and Supplier Quality

Canton, MA 02021

Posted: 07/09/2019 Industry: Biotech/R&D/Science Job Number: 49238

Responsible for day to day management of Compliance and Supplier Quality  Systems within the Quality Compliance group by networking with internal stakeholders and external suppliers to positively influence the compliance health of the company.  This is a key role which contributes to the continuous improvement of quality and compliance at the site. 

  • Primary responsibilities will be to lead and manage the Supplier Quality Systems and Programs. 
  • Lead. Develop, and manage the Compliance and Supplier Quality staff and provide coaching and mentoring on  Quality Systems. 
  • The Manager will participate in internal and external audits, and support  supplier quality management activities at the site and in collaboration with Corporate Quality.  
  • Develop and implement procedures for compliant and effective Supplier Quality Systems. Streamline processes and effectively utilize tools and resources to improve site compliance.
  • Will serve as a Subject Matter Expert on site Supplier Quality Issues and provide guidance and interpretation to internal stakeholders.
  • Work closely with Mfg and Materials Management resources to ensure compliant and available supply of materials for all Mfg processes. 
  • Coordinate and support the site Quality Council to drive continuous improvement and resolve site compliance issues.
  • Establish, track and present Quality Metrics to support Quality Management Review.
  • Provides guidance for higher level decisions required for local change control and deviation investigations.
  • Manage the generation, execution and technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations and internal directives.
  • Review and approve compliance documentation such as Procedures, Contracts, Audit Reports, and Quality Agreements.

Education, Experience & Skills
•  Bachelor Degree in Biological Science or similar science
•  Minimum of 6 years of pharmaceutical cGMP Quality experience with increasing responsibilities.
•  Previous experience in management of Supplier Quality Systems.
•  Previous people leadership experience preferred.
•  Previous experience working with FDA (CBER) and participating in regulatory agency inspections
•  Previous experience with Scheduling, Conducting and Managing Audits.
•  Must have skills for the critical assessment of SOP’ s, investigations, and project protocols for content that will meet compliance requirements.
•  Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment.  
•  Must be able to prepare reports for internal metrics and technical content   
•  Must be able to critically evaluate data summaries and conclusions.
•  Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
•  Must possess strong cGMP knowledge across Compliance functions
•  Must have competence of cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines
QSM or "quality systems management" and QA Supplier and QA Management and Auditing Quality systems and "Effective action plans" and handle product inquiry and adverse reports Manage people. Shay asked abut system based audit; with FDA

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