Job requirements and application form

Job description: The role involves wearing two hats: managing the quality of the manufacturing site and being a member of the plant's management team. The Quality Manager directly supervises four mid-level managers: two Quality Managers, a Regulatory Affairs Manager, and a Compliance Manager. These managers oversee a team of 80 employees. The Quality Manager has 13 Site Quality colleagues across all sites. A significant part of the role involves attending meetings with various stakeholders on topics such as supply chain, engineering, annual operating plans, expenses, KPIs, and strategy. On the quality side: • Quality management at the site to ensure the highest quality standards are met, in accordance with company procedures and regulatory requirements. • Promoting a culture of quality within the plant. • Overseeing audits at the plant, ensuring 100% compliance without any critical findings. These audits may include FDA audits, customer audits, and others. • Working with engineering and maintenance to ensure that systems are operating correctly, preventive maintenance is performed on time, and there are no breakdowns. • Preparing and presenting site data in management meetings. On the site side: • Partnering in the development and implementation of the plant's 3-4 year strategy. • Effectively managing quality risks to protect the business, even if it goes against the plant manager's opinion. •Balancing quality and business needs. For example, knowing when to expedite quality processes and testing to avoid negatively impacting the business.

Requirements: · 10 years of experience in quality management · Experience in a pharmaceutical company - mandatory · Experience working with FDA and GMP regulations - mandatory · Experience in a manufacturing environment - mandatory · Experience managing managers - mandatory · Experience working with senior management - mandatory · Experience in making significant decisions - mandatory · Experience working with clear goals and metrics - mandatory · API experience - advantage · Large company experience - advantage · Strong teamwork skills · Assertive · Proven ability to lead and motivate teams to KPIs and goals · Strong problem-solving skills