![Harba Solutions Inc.](https://media.trabajo.org/img/noimg.jpg)
Director of Quality Assurance
3 weeks ago
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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