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Director of Quality Assurance

Cambridge 175 - 200 Permanent

Responsibilities

  • Recruit, develop, and motivate staff to ensure effective departmental functions and maintain managerial and specialized skills.
  • Provide coaching and mentoring to staff, focusing on job performance and career development, including training, feedback, rewards, and disciplinary actions.
  • Establish organizational and managerial structures that support various levels within the organization.
  • Ensure project schedules meet corporate requirements.
  • Collaborate with project and product managers, and peers in other functional areas, to ensure the successful release of products.
  • Establish, maintain, and report on key performance indicators and applicable department or organizational metrics.
  • Engage in cross-functional projects and team meetings.
  • Work with project teams and research groups impacting quality operations.
  • Assist in evaluating and mitigating program risks and escalating significant quality issues.
  • Operate under limited direction with general guidance on new assignments.
  • Develop, interpret, and implement organizational policies.
  • Address moderately complex problems related to manufacturing processes and schedules for new or existing products, requiring detailed analysis of various factors.


Qualifications:

  • Bachelor’s degree with a minimum of 14 years of experience in a biotech or pharmaceutical regulated industry (including at least 10 years in Quality and 8 years in personnel management). Leadership experience is required.
  • Master’s degree with a minimum of 12 years of experience in the life sciences regulated industry (including at least 10 years in Quality and 8 years in personnel management). Leadership experience is required.
  • Strong working knowledge of ICH, FDA, ISO, and cGMP regulations.
  • Excellent technical writing and presentation skills.
  • Strong leadership and personnel development experience.
  • Excellent communication skills at the organizational, team, and individual levels.
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