Qualification Documentation Manager

Company Description

SKAN is a Swiss company and a global leader in isolators, cleanroom devices, and decontamination processes for biopharmaceutical production. The company's core competency lies in designing and developing process isolators for aseptic filling. SKAN's expertise includes ventilation technology, air conditioning, sterilization, software programming, microbiology, and chemistry, ensuring compliance with regulatory requirements.

Role Description

We are seeking a Qualification Documentation Manager to lead and manage a dynamic team responsible for the creation, review, and management of qualification documentation, including test protocols, reports, and standard operating procedures (SOPs). This is a full-time on-site role for a Qualification Documentation Manager located in Raleigh, NC at SKAN US Inc. In this leadership role, you will oversee a team that ensures compliance with quality management standards and supports the qualification process for both new and re-qualified systems across multiple projects. The ideal candidate will be a strong leader with a deep understanding of GMP documentation practices, qualification processes, and team management. You will be responsible for driving the efficiency of your team while fostering collaboration with cross-functional teams such as SKAN AG, the DE Documentation group, and SKAN US. This is a high-impact role requiring strong communication, organizational, and leadership skills to manage resources effectively and ensure documentation quality.

Qualifications

• Proven experience in a management or supervisory role, leading teams within qualification documentation, quality management, or related fields, preferably in the pharmaceutical, biotechnology, or life sciences industries.
• Strong understanding of qualification protocols, SOPs, GMP documentation practices, and regulatory requirements.
• Excellent leadership, coaching, and interpersonal skills to manage a team and collaborate effectively with cross-functional teams.
• Ability to manage multiple projects simultaneously, ensuring that deadlines and quality standards are consistently met.
• Strong organizational and communication skills, with the ability to manage both people and processes effectively.

Key Responsibilities:

• Team Leadership & Management:
• Lead, mentor, and manage a team of documentation specialists, ensuring efficient allocation of tasks and projects to meet qualification timelines and quality standards.
• Provide direction and oversight to the team on qualification documentation tasks, including the development and review of test protocols, SOPs, and re-qualification reports.
• Monitor team performance, provide regular feedback, and conduct performance evaluations to ensure continuous improvement and development.
• Facilitate team collaboration with internal departments and external partners, ensuring alignment with company goals and regulatory requirements.