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Director of Quality Assurance

2 months ago


Durham, North Carolina, United States BiotechPharma Full time
Job Description

Job Title: Director of Quality Assurance

Job Summary:

We are seeking a highly experienced and skilled Director of Quality Assurance to join our team. The successful candidate will be responsible for leading our Quality Assurance function, ensuring that all aspects of quality are met and exceeded.

Key Responsibilities:

  • Lead the Quality Assurance function: Develop and implement quality policies, procedures, and standards to ensure compliance with regulatory requirements and company policies.
  • Manage quality systems: Ensure that all quality systems, including document control, change control, and corrective action, are in place and functioning effectively.
  • Conduct audits and investigations: Lead internal audits and investigations to identify and correct quality issues.
  • Develop and implement training programs: Create and deliver training programs to ensure that all employees understand quality policies and procedures.
  • Collaborate with cross-functional teams: Work closely with production, engineering, and other departments to ensure that quality is integrated into all aspects of the business.
  • Ensure compliance: Ensure that all regulatory requirements, including cGMP, are met and exceeded.
  • Manage budgets and resources: Develop and manage budgets and resources to ensure that quality initiatives are funded and implemented effectively.

Requirements:

  • Master's degree: In a relevant field, such as chemistry or pharmaceutical sciences.
  • 20 years of experience: In a quality-related field, preferably in the pharmaceutical industry.
  • Strong leadership skills: Proven ability to lead and manage teams.
  • Excellent communication skills: Ability to communicate effectively with all levels of the organization.
  • Strong analytical skills: Ability to analyze data and make informed decisions.