Job Title:
Operations Director
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Job Description:
We are seeking an experienced Operations Director to oversee and manage internal and outsourced activities for R&D, New Product Introduction (NPI), Manufacturing, Maintenance, and Service. This role includes responsibilities for direct management of production processes and release, supervision of sales processes, application of international supply and distribution regulations, and reporting to internal and external stakeholders.
The successful candidate will be responsible for managing the contract for outsourced R&D and NPI activities, ensuring seamless integration and alignment with company goals and product development timelines. They will also oversee and manage the contract for outsourced Manufacturing and Service activities, ensuring seamless integration and alignment with company goals and product demand and needs.
In addition, the Operations Director will directly manage the sales process to the exclusive distributor, ensuring efficient, compliant, and timely supply of products. They will also manage the logistics and compliance requirements for the international supply of products, ensuring proper documentation handling and adherence to global export standards.
The Operations Director will work closely with internal and external teams, including Quality, Regulatory, Commercial teams, and other stakeholders to support products lifecycle management and drive continuous improvement initiatives. They will analyze and monitor process KPIs to identify potential risks in operations, develop mitigation strategies, and manage vendor contracts to ensure adherence to agreed terms and quality standards.
Ultimately, the Operations Director will lead and mentor a team of professionals, fostering a collaborative culture of excellence, innovation, and continuous improvement.
Requirements:
* Minimum of 10 years of experience in operations management within the medical device industry, with specific expertise in managing outsourced activities. Experience with batch release processes, sales management to distributors, and compliance of global supply processes is essential.
* Bachelor's degree in Engineering, Operations Management, or a related field. Advanced degree (MBA, Master's in Operations Management) is preferred.
* Proven success in leading operational functions for manufacturing and sales processes, R&D and NPIs, in a regulated environment.
* Strong strategic thinking and problem-solving skills.
* Excellent contract management and negotiation skills.
* Proficiency in operational management software and tools.
* Exceptional communication and organizational abilities.
* Dynamic and adaptable to a fast-paced, innovative business environment.
* Strong business acumen with a proactive approach to operational challenges.
* Collaborative mindset with the ability to work effectively across multifunctional teams and cultures.
* Results-oriented, with a focus on driving efficiency and meeting business objectives.