Director, Quality Control

Job Locations US-MA-Bedford
Posted Date 4 weeks ago(6/11/2020 9:20 AM)
Job ID
2020-1327
# of Openings
1
Category
Quality

Overview

Directs the development, planning, implementation, and maintenance of Quality methods, processes, and operations for new or existing products and/or technologies.  The QC group is comprised of the following functions: QC systems, Analytical Chemistry, Microbiology (including Environmental Monitoring), Method Validation, Stability and support.  Provide strategic and tactical leadership to the Quality organization ensuring the execution of responsibilities within the Quality System.This position manages people and is responsible for all work completed within the QC group for pharmaceutical and medical device products across the entire product lifecycle. 

Responsibilities

  • Directing the development, validation, planning, implementation, and maintenance of QC test methods, processes and operations applicable to the lifecycle stage of the product.
  • Provide leadership for the Quality Control function through development and implementation of the overall quality strategic plan.
  • Coordinates with Quality Assurance to ensure contract laboratory service providers are suitably qualified to conduct the services contracted to them.
  • Coordinates with Quality Assurance to ensure Quality Agreements are complete, approved and updated at appropriate intervals.
  • Responsible for ensuring GCLP principles are implemented and adhered to within internal and external laboratories.
  • Manages internal and external cGMP laboratories by reviewing and approving documents as required, including SOPs, protocols, reports, test methods, change requests, technical transfers, OOS investigations.
  • Responsible for the development and validation of test methods in accordance with international guidelines.
  • Responsible for ensuring that raw material, in-process and final release testing is accurate and reported to meet timelines.
  • Responsible for ensuring the appropriate stability programs are initiated and completed to support both clinical and commercial products.
  • Responsible for the design and execution of the site environmental monitoring program.
  • Determine and implement sterility and biological test/validation requirements utilizing appropriate industry standards for new products.
  • Ensures projects are provided the suitable QC resource to meet common goals and timelines.
  • Interface with R&D and Regulatory Affairs to ensure that all material specifications are suitable for their intended purpose.
  • Develop, refine, and document quality control test and inspection procedures.
  • Ensures quality control systems and equipment are compliant to all applicable regulatory guidelines and data integrity principles are adhered to, to provide confidence in the data generated.
  • Tracks and trends cGMP data including the evaluation and approval of data received from external contract laboratories. Compiles and reports data with appropriate interpretations for internal Management Reviews, Annual Product Reviews, and all other required assessments.
  • Responsible for the retain sample management program.
  • Responsible for the escalation of significant issues to Head of Quality.
  • Ensures continuous improvement across the Quality Control Group.
  • Responsible for the overall development of QC staff.
  • Other duties as assigned

Qualifications

  • Manager, QC Systems, Quality Analytical Chemistry, Stability, Analytical Validation, Microbiology.
  • BS degree in a scientific/engineering discipline required; advanced degree in analytical development preferred.
  • Must have a minimum of 10 years of experience in a pharmaceutical quality control role (CMC, Phase 1-3 clinical development); 5 years in a management position.
  • Must be knowledgeable in the application of quality principals and industry guidelines for Quality Systems.
  • Demonstrated knowledge and experience in analytical development
  • Must be able to advise and/or teach others on the quality requirements of the company, including products, customer requirements and the interpretation of various industry guidelines.
  • Must have experience in risk-based decision making.
  • Demonstrated operational excellence of laboratories.
  • Must have strong hands-on leadership and communication skills.
  • Must be able to conduct an audit; must be able to be audited. Must be familiar with statistical principals as they relate to statistical sampling plans
  • Minimal travel
  • Ability to gown and gain entry to manufacturing areas.

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