Regulated Biopharmaceutical Interface Specialist
Skillful professionals are sought after to serve as primary points of contact between client stakeholders and Global Facility Delivery (GFD) team, ensuring all expectations, updates, and requirements are clearly communicated and documented.
Key Responsibilities:
* Foster Collaboration: Ensure seamless communication between teams by coordinating regular meetings to drive project progress, capture action items, and maintain alignment across departments.
* Manage Change Controls: Initiate, coordinate, and track change control processes in accordance with internal and regulatory requirements, guaranteeing compliance and quality standards.
* Document Oversight: Oversee scheduling and execution of document reviews, ensuring timely completion and submission of technical, quality, and compliance documentation.
* Monitor Document Status: Track document status and proactively follow up to mitigate delays and ensure projects stay on schedule.
Qualifications:
* Bachelor's degree in Engineering or equivalent experience in biopharmaceutical or pharmaceutical sector.
* Minimum of 3 years' experience working in highly regulated environments, preferably in biopharmaceutical manufacturing or facility delivery.
* Proven experience managing change controls and working with document management systems in a GxP environment.
* Strong understanding of quality management systems (QMS), good manufacturing practice (GMP), and health & safety regulations relevant to biopharmaceutical operations.
Key Attributes:
* Collaboration: Demonstrates a diplomatic approach to engaging stakeholders from diverse functional backgrounds, fostering a culture of inclusivity and respect.
* Accountability: Takes ownership for meeting schedules, documentation deadlines, and compliance obligations, consistently delivering results under pressure.
* Adaptability: Comfortable managing competing priorities and adapting to rapidly changing project demands, demonstrating flexibility and resilience.
This role requires an exceptional ability to communicate complex information, facilitate collaboration, and ensure compliance with regulatory requirements. If you possess strong organizational skills, excellent communication abilities, and a passion for delivering high-quality results, we encourage you to apply for this challenging and rewarding opportunity.