• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Site Quality Head

Job Number: 24805

Location:

Job Description

The Site Head actively provides guidance to multiple Quality departments at the Billerica, MA site, including the Quality Management System (QMS), Quality Assurance, QC Microbiology, and QC Chemistry groups, to ensure compliance to all applicable FDA procedures, policies, and regulations.  Direct involvement in the establishment of implementing global procedures and policies to ensure cGMP compliance at the site.  Ensure that all products are tested and released strictly under cGMP conditions.

Responsibilities

  • Ensure that the global quality policy is understood, implemented, and maintained at all levels of the organization 
  • Ensure that products are designed and produced in accordance with the requirements of the QMS
  • Provide quality management and technical input into the design, development, construction and establishment of a new manufacturing facility housing state of the art isolator filling line
  • Routinely assesses and determines optimal organizational structure and resource requirements to assure compliant performance and timely completion of priorities
  • Evaluate, recommend and implement improvement strategies to company Quality Systems to ensure that Quality Requirements are consistent with Current Guidelines and Industry Standards
  • Actively interact with and influences the development and formalization of corporate laboratory control standards, policies and guidelines
  • Actively develop strategies and actions to continuously improve data management practices and test method reliability assuring continual inspection readiness and on time release expectations
  • Work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, root cause analysis and risk assessments
  • Provide leadership and direction to the Compliance team focusing on development of the skills and effectiveness of the group
  • Act as key driver of enhanced scientific skills in staffing and optimize departmental productivity
  • Partner with Business Development to create billable contract services related to Quality function
  • Lead and direct the work of others and relies on extensive experience and judgment to plan and accomplish goals
  • Other duties as assigned

Required Skills

  • BS in related scientific field required; Master’s degree in related scientific field preferred
  • Expertise in establishing effective quality systems in a pharmaceutical/ biopharmaceutical industry
  • Thorough understanding of cGMP requirements as they relate to regulatory compliance and statistical reporting
  • Understanding of scientific methods and the ability to interpret and communicate data to management, customers and regulatory agencies 
  • Exhibit a wide degree of creativity, flexibility,   innovation and a strong focus on quality, compliance and cost control 
  • Communicate cross functionally; must be a team player and process facilitator with the ability to be diplomatic, assertive, and must be proficient in conflict resolution 
  • Ability to work in a fast paced, constantly changing work environment and approaches responsibility with a strong sense of urgency
  • Knowledge of applicable international regulations and standards 
  • Excellent verbal,  written and interpersonal communication skills and an effective negotiator
  • Minimum of 15 years related experience in a Pharmaceutical/drug (FDA Regulated) industry within the Quality Assurance/Quality Control environment
  • Minimum of 10 years of experience in a Quality Management leadership role
  • Experience with 21CFR 210, 21CFR 211, and 21CFR 820 required
  • Significant experience in sterile product manufacturing environment
  • Experience in validation protocol review for equipment, process, and methods and experience in risk management preferred
  • Working knowledge of  cGMPs, ICH Guidance Documents
  • Sound knowledge in a GMP Regulated environment, solid experience in GMP auditing

 

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