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Quality Control Manager
hace 58 minutos
Spain, PorrinoToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The site is growing and constantly adapting to our customers’ needs. As part of this exciting evolution, we are currently looking for a QC Manager. In this role, you will manage the analytical testing organization reporting directly to the Head of QC. It is a newly established, challenging role for which we are seeking an individual with strong leadership and communication skills to further develop the organization. Internal and external customer and stakeholder management will be the key to success
Key Responsibilities:
- Assume overall responsibility for departmental budget. Provide leadership to a multilayer organization of leaders, technical supervisors and lab technician to ensure organizational readiness to absorb current and future growth business specifically.
- Ensuring workforce planning, and ensuring organizational readiness to absorb the growth curve in-line with forecast. Developing effective interfaces, fostering close collaboration with internal and external customers and stakeholders ensuring smooth QC 24/7 support.
- Ensuring an inspection readiness state for the laboratory to meet expectations from customers and regulators. Developing and maintaining a robust communication and escalation process to internal and external stakeholders and customers.
- Driving a lean mindset and establishing mechanisms to continuous improvement initiatives to be executed in line with plan. Ensure main laboratory management systems are in place and developed to the next level.
- Develop strategy and plan to ensure Laboratory Capacity is fit for purpose (short-, mid-, and long-term).
- Orchestrate main Quality Systems and ensure adherence to main regulations (ICH, CFR, GMP Regulations, Pharmacopeias) Establish a continuous improvement mindset.
- Ensuring robust hiring plan, focus on training and retaining energized, motivated, team oriented staff.
- Oversee and manage departmental performance and quality metrics. Assume a “Customer First Mindset” and ensure technical and compliance positioning is accurate.
- Oversee laboratory activities to support investigations, different studies, qualifications and/or method validations.
- Tracks QC testing, manages project commitments, follows through on action items, coordinates analytical teleconferences if applicable, and participates in problem solving of issues.
Key Requirements:
- University Bachelor’s degree in Biotechnology, Bioengineering, Chemistry, Chemical Engineering or related disciplines with at least 10 years of experience in GxP positions with progressive experience in Biologics/Biopharmaceutical/Pharmaceutical industry or MSc/Ph.D degree with at least 8 years in GxP positions.
- Comprehensive knowledge of global GMP regulatory requirements for Quality Control laboratory operations and data integrity.
- Strong leadership skills and ability to communicate effectively internally and externally at higher levels (e.g., executive management).
- Detail oriented with exceptional organizational skills and a structured and proactive working attitude. Open-minded for new ideas with a highly collaborative and strong team oriented attitude. Demonstrated, well developed analytical and problem-solving skills
- Strong drive for results and high capacity to mobilize teams and stakeholders.
- Fluent in English.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
- Reference: R58873
