Senior Global Quality
Zhejiang Hisun Pharmaceutical Co. Ltd. was established in 1956 and currently employs over 9000 people, and is a public trade company (stock code 600267). Hisun’s vision is to become a widely respected international pharmaceutical company by advancing its mission of persisting in pharmaceutical innovation for the benefit of human beings. Hisun focuses on the integration of pharmaceutical research and development (R&D) with production resources to provide its global customers with outstanding products and services. To date, over 40 of the company's products have passed certification by the FDA (U.S.), EDQM (EU), TGA (Australia), KFDA(Korea), etc., and are sold in more than 30 countries worldwide.
Hisun Pharmaceuticals USA, Inc. was established in Princeton, New Jersey in November 2009 and is a wholly owned subsidiary of Zhejiang Hisun Pharmaceutical Co. Ltd. Currently we have an opening in our Sales Organization：
The Senior Global Quality position is accountable for ensuring that all company global quality systems are fully compliant and is responsible for ensuring effectively that all operations respect quality systems at all times. The Senior Leader in Quality is also accountable for ensuring right first time CMC file submission and updates. He/she provides strategic and most importantly operational quality leadership for the Zhejiang Hisun Pharmaceutical across the world. This position also:
- Defines, leads and ensures the implementation of company Quality policy, and advises the executive committee on all quality matters. The senior authority on quality for the company.
- Protects the company against regulatory action by ensuring compliance with regulations in all markets and in all sites.
- Defines and manages an effective and efficient Group Quality System.
- Drives competitive advantage by leading ’s effort to develop and implement global quality methods through more consistent operational infrastructure of our systems, processes, and resources.
- Supports the business on enabling global quality initiatives.
- Provide professional expertise and support to the company on all Quality matters; the ultimate decision maker for all quality matters including recall, while taking into account local regulations and requirements.
- Direct, guide and support from a functional standpoint the Heads of site, affiliates and functional Quality Teams in order to ensure that products, systems and facilities are in a state of sustainable and efficient compliance with the requirements of regulatory authorities worldwide and with company Quality standards.
- Design and implement comprehensive & multidisciplinary quality training programs across the manufacturing and R&D sites to introduce new or revised procedures, systems and regulations.
- Manage talent selection, training, development, succession planning, and performance management of Global Quality function.
- Lead the establishment of a consistent and high standard quality culture throughout the company and be particularly active in identifying areas for improvement. Provide leadership, clear objectives and guidance in integrating Quality Management & Compliance and Operational Excellence into the business process whilst ensuring policies and procedures are understood.
- Define appropriate organizational structures, measures and management review processes and report on the performance of the global and local Quality Systems.
- Define the Quality budget in agreement with senior management and respect the agreed budget and headcount; optimizing the use of resources throughout the company.
- Set a clear, defined, best practice company policy and guidance on quality, ensuring compliance with regulatory requirements, and consistency of approach across the company.
- Partner with business leaders in establishing world-class systems that deliver competitive advantage, enable ongoing cost reduction, and concurrent business growth.
- Deliver strategic projects on aggressive timelines and within budget.
- Ensure operational best practices, processes and procedures are defined, documented and implemented company- wide that satisfy quality system requirements.
- Define a vision and roadmap for quality across the company, driving delivery through clear objectives and effective performance management.
- Audit and assess compliance with company policy, regulations and s N.B. This part of the organization is currently under discussion to transfer to the Corporate Auditing group.
- Must be able to apply collaboration skills in a geographically dispersed and culturally diverse business. Proven ability to lead diverse teams and work collaboratively with team members at all levels.
- In-depth operational knowledge of budget and financial measurements and their application in major business segment operations
- Degree level;
- Excellent knowledge of Quality Management and of Regulatory Compliance. Experience of integrating these with Excellence programs such as Lean, Six Sigma, together with the associated culture change;
- A track record of creating effective, well recognized and proactive Quality organizations, well aligned with business strategy and needs and integrated with operations around the world;
- Requires strategic vision, business skills, and proven leadership in developing, implementing, and supporting innovative business solutions across the Group;
- Proven ability to direct cost-effective quality programs in a highly regulated and high-risk environment, with extensive first-hand experience of management within a multi-national bio-pharmaceutical company; this will include success with FDA, MHRA/EMA and other authorities of similar standing;
- A strong record of selecting and developing very competent, energetic and forward thinking professional staff;
- Strong practical work experience (10-15 years) in the Pharmaceutical Industry; e.g. Plant/Division/Business/Corporate;
- Success in a multicultural international environment;
- Recognized and proven Leader who is able to motivate his/her people to deliver outstanding results with or without hierarchical relationships, and through well-developed emotional intelligence;
- Possess entrepreneurial skills in terms of innovation and problem-solving;
- Have tenacity, pragmatism, tough-mindedness, strong interpersonal skills and the ability to influence at all levels of the organization;
- Results-oriented, and self-motivated professional with strong commitment;
- Have the ability to build strong working relationships across many different functions;
- Demonstrated ability to influence decisions toward long-term organizational objectives and communicate clearly and persuasively in positive and negative situations;
- High learning agility; willingness to take in broad perspectives and adapt strategies & operations to reach best-in-class;
- Demonstrated leadership management experience and problem solving as a member of cross-functional teams;
- Fluency in English and Mandarin is required;
- Requires a comprehensive knowledge of leadership and management principles, strategic planning, project management and roll-out processes and systems.
Interested candidates should submit their resumes to email@example.com