Beschreibung

In this role, you will lead the development of protein-based products, ensuring compliance with regulatory standards while fostering a collaborative team environment. Your daily responsibilities will include overseeing product changes, managing deviations, and driving excellence in quality assurance.

Anforderungen

• •Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
• •Advanced degrees (e.g., MSc, PhD, MBA) highly desirable
• •Extensive experience in R&D Quality or Product Quality
• •Deep understanding of ICH guidelines (Q8, Q9, Q10)
• •Long-term business and pharmaceutical understanding
• •Proven ability to lead and develop teams
• •Exceptional analytical and problem-solving skills
• •Excellent communication and interpersonal skills

Aufgaben

• •Build and lead a data-driven team
• •Develop and implement a metric-driven leadership approach for protein-based products
• •Ensure alignment with risk management principles and regulatory guidelines
• •Provide leadership for protein-based products from a Quality Assurance perspective
• •Ensure phase-appropriate development while adhering to QMS and GMP standards
• •Oversee critical product changes related to regulatory compliance and quality
• •Guide changes across the product lifecycle for safety, efficacy, and manufacturing
• •Manage critical product deviations impacting compliance and quality
• •Lead thorough investigations and resolutions of product deviations
• •Communicate deviations to mitigate risks and maintain compliance
• •Foster a culture of collaboration and accountability within the team
• •Focus on team development and alignment with organizational priorities

Benefits