Manager of Qualification Management

SKAN US, Inc., a world leader in pharmaceutical isolators, based in Raleigh, NC is accepting applications for the position of Qualification Management Specialist. This position is based out of our SKAN US facility in Raleigh, NC. The position reports to the Qualification Manager at SKAN US.

SKAN, headquartered in Switzerland with a strong US presence, is a global leader in the pharmaceutical industry for its cleanroom equipment. This equipment is routinely used in vaccine development, production of pharmaceutical products, and other critical operations to ensure the safety and quality of pharmaceutical drugs.

Our US base is comprised of a parts business, a field service/assembly team, a microbiology team, a documentation qualification department, and a field qualification team, among other administrative functions.

SKAN is experiencing rapid growth and is looking forward to welcoming several members to the SKAN family!

• Lead, mentor, and manage a team of Qualification Management specialists, ensuring effective resource allocation, workload distribution and timely completion of qualification activities in accordance with established quality standards and customer commitments.
• Provide technical and operational direction for qualification management activities, including development of protocols, templates, and completion of binder reviews.
• Review and approve qualification documentation and completed qualification binders to ensure accuracy, completeness, consistency and compliance with applicable procedures and regulatory requirements.
• Foster effective collaboration with internal departments and external partners.
• Serve as subject matter expert for qualification documentation, processes and customer requirements, providing guidance and resolving issues as needed.
• Identify opportunities to improve departmental processes, workflows, documentation practices and resource utilization and lead the implementation of process improvements.
• Support recruitment, onboarding, training, and development of Qualification Management personnel to build a capable and high performing team.

• Demonstrated experience leading, developing and managing small to mid-sized technical or professional teams
• Experience assigning and prioritizing workloads across multiple projects, customers and competing deadlines.
• Proven ability to work directly with customers, manage expectations, resolve issues and maintain a strong customer-focused approach
• Conducted field qualification at customer sites, ensuring smooth execution and compliance.
• Skilled in creating, modifying, and following SOPs and work instructions.
• Basic technical understanding of isolator systems.
• Strong understanding of GMP principles and regulatory requirements.
• Bachelor’s degree in mechanical engineering, pharmaceutical technology, chemical engineering or related technical field.
• Minimum of one year of relevant professional experience following completion of bachelor’s degree; additional experience in qualification, validation, field service, engineering or a regulated environment is preferred.

• An open corporate culture and teamwork
• Short decision-making paths and flat hierarchies
• Intensive orientation and training programs through our SKAN Academy
• Excellent base salary with potential annual bonus opportunity
• Major medical, dental and vision for employee and family
• Short-term and long-term disability for employees
• 401K with 100% company match up to 6% immediately vested
• 15 paid vacation days and nine observed company holidays per year, generous rollover policy

Whether you have a question about our products, need technical support or would like to find out more about our solutions.