This position will manage Incyte’s Commercial QA Manufacturing group.
This role is responsible for the global Quality operations related to the manufacture and testing of all commercial drug substances and drug products, of both chemical and biological origin. He/she will ultimately ensure the compliance of manufacturing with cGMP and registration files.
The position is responsible for driving and coordinating all quality assurance manufacturing activities for New Commercial Product Introduction.
The position is also responsible for implementing a continuous improvement mindset and program across the commercial manufacturing organizations.
The Director Global Commercial QA Manufacturing will be a member of the Quality Management Team. He/She will develop and maintain a strong collaboration with Manufacturing functions as well as external partners.
Duties and Responsibilities
• Manage and develop the Incyte Global Commercial QA Manufacturing group
• Drive the Quality oversight of the commercial products manufacturing globally,
• Lead and Manage all quality and compliance related aspects associated to Commercial Manufacturing including management of associated changes, deviations, disposition,complaints and CAPA
• Represent QA Management in Change Review Boards and Material Review Boards
• Coordinate the transfer of activities from Development QA to Commercial QA groups
• Oversee for QA, Technical Transfers, Process and Method Validation activities and Continuous Process Verifications
• Drive resolution of internal and external serious quality issues
• Ensure Continuous alignment of practices across manufacturing sites for dual sourcing
• Drive and coordinate all QA manufacturing activities for new Commercial Product Introduction to ensure launch readiness
• Lead the GMP Contractor Quality Management Program and propose new ways of working to increase effectiveness of Contractors’ Quality Oversight
• Lead the Technical Quality Agreements Program with CMOs
• Manage the Quality and Business Reviews Program with CMOs to ensure sustained compliance and performance
• Ensure inspection readiness across Incyte CMOs for product related inspections
• Assess CMO’s Quality risk levels and ensure risks’ mitigation
• Perform audits according to the Global Audit Program
• Organize, drive and monitor execution of strategic Quality Manufacturing initiatives
• Ensure Commercial QA Manufacturing set of SOPs is maintained and remains state of the art for compliance and efficiency
• Develop and monitor Quality Metrics pertaining to Product Manufacturing and CMO compliance
• Deputy of Senior Director Global Commercial QA
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements
• Stay current with the applicable regulations and promote Quality across the Incyte organization
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
• Doctorate or Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
• At least 10 years in QA for international pharmaceutical and/or biotech industry acquired at manufacturing sites and/or overseeing CMOs;
• Experience in both solid oral dosage forms and biotech/sterile products
• Thorough knowledge in cGMP and global regulatory requirements (US, EU, JP, CH);
• Sound awareness and understanding of pharmaceutical and biotech business;
• Solid experience in team management, with a strong focus on team development;
• Strong business Mindset with proven ability to strategic thinking
• Strong Interpersonal skills;
• Strong verbal and written communication skills with well-structured communication and presentation ability;
• Results focused which may require negotiating skills, empathy, diplomacy, common sense
• Project Management Experience
• English fluency written and spoken (the company language);
• Travel up to 25%
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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