Director, Global Clinical Quality (GCQ) Quality reports to the Senior Director of Global Quality Management and will be responsible for ensuring compliance with Good Clinical Practice (GCP) / Good Manufacturing Practices (GMP) and established guidelines for regulatory standards for clinical studies, as well as company policies/procedures.
This position is the key contact for internal business partners as well as CRO and clicinal sites for the developent, execution, and inspection readiness of global clinical studies.
Experience managing Phase I - Phase IV programs
Experience and thorough knowledge of local and global regulations (e.g., FDA, EMEA, MHRA, etc.), clinical pharmaceutical research and development process and audit principles and practices
Demonstrating proficiency within ICH guidelines, especially GCP
Sound awareness and understanding of the pharmaceutical business, especially with regard to the Quality, Compliance and regulatory requirements of clinical development
Some experience and knowledge of GVP and GLP is a plus
Experience managing others, Able to communicate in a diplomatic, clear and efficient style
Proven leadership and management skills including problem solver and Operational efficiency
Lean Six Sigma certified or in progress, Ability to prioritize and manage multiple responsibilities
High degree of accuracy and attention to detail;
Driving Innovation and Digitization in the Pharmaceutical Quality space with demonstrated examples of value add.
Good judgment/analytical thinking and strategic performance: Able to differentiate between critical and non-critical issues and to then initiate the appropriate steps
Demonstrated leadership and, interpersonal skills as well as proven ability to work in a multi-disciplinary team setting including the ability to partner
Ability to work both independently and as part of a team
Minimum of 15 years within the pharmaceutical industry, including a minimum of ten years in research and development preferably as an GCP auditor/compliance advisor, clinical research associate/monitoring, data manager, clinical supply manager, and/or managing clinical sites
More than 4 years of GCP auditing and/or Quality operations/management experience preferred
Advanced degree(s) preferred
Travel (approximately 30-40% )
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyondunder any circumstancesfor patients, families, providers, and for each other. Its this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho the achievement, completion, and discovery of truth; and Sozosei pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility. Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en . Learn more about Otsuka in the U.S. at www.otsuka-us.com .
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
At Otsuka, our people are passionate about developing and delivering original products as part of a global holistic commitment to better health and well-being. We have two core businesses dedicated to achieving our goals: a pharmaceutical business and a nutraceutical business. The pharmaceutical business develops and markets products for the diagnosis and treatment of disease in the following areas: central nervous system, oncology, gastroenterology, ophthalmology and cardiovascular. The nutraceutical business is dedicated to maintaining and improving health through the use of foods and beverages that provide extra health benefits in addition to their basic nutritional value. Since the beginning, nearly 100 years ago, the Otsuka family sought to develop products that stood out from the crowd, by traveling down the paths of discovery where others were less likely to tread.
We believe our culture and our people are the differentiators that empower us to produce breakthrough results. This is what makes us a big venture company that takes risks and focuses on unmet medical needs in order to develop new and better therapeutic compounds. We harness the extraordinary cr...eative and innovative abilities of our people to solve problems differently, and to persevere until they find answers. We are in this for the long-haul. Otsuka is a highly ethical company. We adhere to the highest standards in how we develop and deliver our products, and in how we treat our most valuable assets: Otsuka-people. We encourage them to follow their dreams, as turning dreams into reality is at the core of everything we do. It paves the way ahead to achieve our shared purpose: impacting on human health to help people live better lives.