This role is responsible for leading and overseeing all quality assurance activities at the site. This sole ensure compliance with regulatory and company standards through proactive quality oversight and continuous improvement initiatives. The Sr. Manager will drive harmonization and efficiency of quality processes ensuring alignment with organizational goals. Key focus will be on fostering a strong quality culture, developing and engaging talent, and enhancing customer satisfaction; both internal and external to best fulfil our Mission and Vision and make life more rewarding and dignified for the people who use our products. This role will play a critical role in achieving site and global objectives through effective leadership and operational excellence.

Responsibilities

• Oversee all quality assurance and QMS activities at the site to ensure compliance with applicable external and internal requirements
• Maintain a robust and effective Quality Management Systems that supports audit readiness and meets all applicable regulatory and internal requirements ensuring proactive identification of risks identification and mitigation
• Provide quality direction and hands-on oversight to ensure product, processes and system compliance across all departments.
• Identify, coordinates and implements process improvements and efficiency initiatives in alignment with global objectives to enhance quality, reduce risk, and support operational goals.
• Defines and disseminate quality goals and objectives in alignment with Global Goals and Objectives and strategic initiatives.
• Drives standardization and harmonization (when appropriate) of quality practices to ensure consistency and best-in class performance.
• Manages, lead and develop a high-performing QA team. Fosters a culture of accountability, engagement and continuous learning.
• Collaborate with internal and external stakeholders to ensure high levels of customer satisfaction through timely resolution of quality issues and continuous service improvement.
• Ensures product quality decisions are made timely and based on risk to quality and business.
• Shares lessons learned and best practices with relevant parties to support strengthening Hollister performance globally.
• Serves as a site lead for inspections and audits.
• Ensures timely responses and effective CAPA completion.
• Partners closely with manufacturing, supply chain, R&D, Design Assurance, Regulatory and other functions to ensure alignment and support of business objectives.
• Establish and track quality KPIs. Communicates performance trends and escalate risks and improvement opportunities to senior leadership as appropriate.
• Responsible for ensuring Quality Management Reviews are held according to external and internal requirements and provides inputs for Global Quality Management Review including action plan status updates.
• As part of Hollister’s Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required.
• Develop and advise on the continuous improvement of quality system processes and procedures. Maintain a healthy quality system for sites of responsibility.
• Build and deliver effective communications at all levels while displaying active listening skills.
• Provide leadership in change management and risk assessment for process / product changes.
• Advise and participate in IT solutions for quality system improvements.
• Participate in due diligence audits regarding potential product acquisitions.
• Other duties and tasks as assigned.
• Ensure training is provided pertaining to good manufacturing practices (FDA, ISO and MDSAP countries)
• Where required, Act as liaison with all regulatory agencies including FDA, HPRA and notified body NSAI as needed.

Education & Work Requirements

Education & Work Preferences

• Advanced degree is desirable.

• Thorough Knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR etc.).
• Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
• Good working knowledge of continuous improvement and root cause problem solving in a manufacturing setting.
• Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
• Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies.
• Good interpersonal skills with the ability to work as part of a cross functional team.
• Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner.
• Fiscal Management
• Have a continuous improvement mindset and demonstrated change management skills.

Company offers

• Learning and development-oriented culture
• Annual bonus based on personal performance
• A benefits package, including health insurance, to support your well-being
• Flexible working hours
• Fresh and healthy breakfast and lunch at our site's restaurant, available at an exclusive company price
• Team-building, summer festivals, and special events
• Free charging stations for electric cars
• 24/7 accident insurance.

We guarantee confidentiality and will inform only selected candidates.

Salary

5800 - 7600 €/mon. gross
From 5800€/mon. gross after assessing your competencies and work experience.