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Head of Quality
Alabaster, AL 35007 US
- Lead and manage the performance of QC and QA departments, including goal setting, training, performance evaluations, and disciplinary actions as necessary. Direct reports may include managers, team leaders, graduates, and administrators.
- Provide a technical support service to other departments as required including customer inquiries and complaints.
- Develop, implement, and maintain robust quality management systems aligned with regulatory standards and business objectives, emphasizing competence, cooperation, and risk control
- Identify, investigate, and resolve quality issues, interpreting legislation and collaborating across departments and regulatory bodies. Advise on product recall situations as needed. Dealing with problems ranging from simple to complex, involving multiple site departments and regulatory bodies.
- Effectively communicate with internal and external stakeholders, including senior management, regulators, customers, and suppliers. Represent the site with quality regulators and actively participate in global quality leadership teams. Deliver detailed reports and presentations on broader quality topics. This role participates as an active member of the site senior management team and the global Quality and Regulatory leadership team.
- Make critical decisions within the Quality department, collaborate on significant site activity changes, and effectively plan and organize multiple projects to meet improvement and regulatory deadlines.
- To effectively plan and organize multiple projects, ranging from short-term to several years in length, and all department activities to achieve continuous improvement and regulatory/group deadlines.
- Advise on Quality elements of the capital planning process and projects.
- Manage the Quality Unit's budget and facilitate the site's Quality Management Review process.
- Other duties may be assigned.
- Master’s Degree in Science, PhD preferred.
- Minimum of 10 years’ experience in a Quality role in a cGMP environment.
- Auditor qualification.
- Expertise in cGMP Quality regulations for Active Pharmaceutical Ingredients and FDA regulations.
- Experience with other Quality Standards and guidelines (ISO9001, EXCiPACT, EU GMP)
- Knowledge of Quality Requirements throughout clinical development phases. Experience with outsourced Manufacturing.
- Ability to perform work at a high and consistent standard, paying attention to detail.
- Strong leadership, change management, and communication skills at both internal and external levels.
- Ability to influence others to comply with site systems and achieve similar high standards.