Manager Quality Assurance Compliance

Summary

The position will provide strategic QA leadership and operational direction to the QA Compliance team, ensuring the optimization and continues advancement of Quality Management System (QMS) in alignment with regulatory requirements and corporate objectives. 

Responsibilities

• Lead and promote a strong culture of compliance with GMP, QMS, FDA, and ISO requirements through training and continuous awareness.
• Provide QA compliance leadership and drive continuous quality improvement initiatives.
• Partner with Manufacturing and Quality teams to maintain and improve product quality, address quality issues, and support Cost of Quality and Quality Culture initiatives.
• Oversee internal audit programs and manage external audits, inspections, and regulatory interactions.
• Monitor and report quality metrics, communicate risks, trends, and improvement opportunities to senior leadership.
• Lead Quality Management Reviews and ensure compliance with internal and external requirements.
• Act as the primary liaison and Management Representative with regulatory authorities, certification bodies, and as the Person Responsible for Regulatory Compliance (PRRC).
• Lead and develop the Quality Compliance Team by developing and maintaining a plan for the professional development and coaching of all direct reports.
• Develop, Implement and Maintain effective QMS within the plant and support global quality procedures – in line with regulatory requirements.
• Provide resources for maintaining, archiving, and control of QMS documents and records, Quality Software implementation and validation.
• Oversee the Corrective and Preventive Action (CAPA) process and Quality Plans

Education & Work Requirements

Education & Work Preferences

• Supervisory experience required with excellent independent judgement and interpersonal skills.
• Project Management skills required.
• Strong technical writing skills and attention to detail.
• Knowledge of applicable foreign and domestic regulations.
• Knowledge of quality engineering tools and statistical quality control techniques.
• Knowledge of quality auditing techniques in FDA/ISO regulated environment preferred.
• Knowledge of process validation techniques.
• Basic knowledge of sterilization.
• Knowledge of Good Manufacturing Practices, ISO 13485 and FDA CFR Part 820.
• Greenbelt certification preferred with knowledge of Lean and Six Sigma methodologies required.
• Knowledge of ERP systems preferred.
• Strong in Microsoft Office suite, especially Excel.

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

4600-6700 €/mon. gross
Salary from 4600 (before taxes) after assessing your competencies and work experience.