Associate Director Clinical Quality Assurance is responsible for internal and external Clinical QA & QM Activities to support Clinical quality assurance program and quality systems. This includes QA review of clinical trial documents, data integrity assurance, GCP compliance at clinical sites and internally, clinical vendor (CRO) audit, CRO qualification and management, internal and external GCP quality audits, Inspection readiness and supporting clinical CAPA resolutions and effectiveness.This position is critical to clinical quality assurance activities internally at Otsuka and ensure documentation is appropriate, and critical service providers such as CROs, test labs and clinical sites are compliant to GCP. Primary function of this position is to provide the daily hands on support to the Clinical Quality team and Clinical organization with respect to Otsuka clinical QA and external facing Quality assurance, clinical compliance, clinical quality assurance and clinical vendor management and control.Key responsibilities of this function include management and control of activities at key vendors like the CROs, biometrics and data management vendor, Safety database vendor, labeling and distribution etc. These subsystems need substantial sponsor oversight during the formative stages. This function will also support phase II requirements such as PAI inspection preparation, readiness and quality representation.This position will participate on clinical process improvement projects and initiatives, supporting departmental and corporate quality goals and priorities, while ensuring products, processes and systems effectively meet expectations of Otsuka Global Clinical Quality Assurance and Overall Business from a clinical development GCP compliance perspective from concept through commercialization. The successful candidate will be a seasoned professional with experience in clinical quality assurance, clinical research management, data management and clinical quality assurance function in a clinical stage pharmaceutical or combination product organization.
GCP QA will provide advice on the interpretation and application of the regulatory requirements. Provide Clinical researchers advice in resolving non-compliance issues in a professional and pragmatic way. This individual will be responsible for both auditing and providing guidance on GCP. The individual also acts as a GCP quality adviser to the functions involved in the drug development process and providing trouble-shooting advice and interpretation of regulations and guidelines. Addressing Clinical Quality events and Driving robust Clinical Functional Area partnership and engagement for High Quality Culture
Support internal and external organizations:
The GCP QA professional will identify areas for improvement and update procedures and policies related to GCP practices. Interact with different groups within the organization and outside including clinical research, outsourcing/contracts, IT, data management and biostatistics, clinical trial supplies, pharmacovigilance, regulatory affairs, SOP management groups and training functions. Externally, GCP QA professional will interact with a diverse range of groups such as third-party serviceproviders, CRAs, Investigators, Study Nurses and other study site personnel, and in the event of inspections the regulatory inspectors.
Auditing and Report Writing:
The type of audits that may be conducted includes: Third party service providers; Clinical trial sites; Quality Systems audits; Documentation audits; Computerized systems; Inspection preparation.
This position provides the essential, hands-on day-to-day support to the organization, specifically to the Otsuka Global Quality management in CRO management, internal GCP compliance and preparation of key activities leading to PAI inspections, Sponsor and Clinical Site Inspection Hosting and training , Inspection Readiness preparations oversight and control to ensure PAI Inspection readiness, vendor oversight management, vendor investigation, deviations and CAPA.
Perform diagnostic and descriptive analytics to identify performance trends, root cause assessments and identify areas of continuous improvement
Participates on clinical project teams and influence and encourage clinical teams towards a state of inspection readiness at all times.
Consultant support for compliance and regulation questions including quality review of clinical study documents
Participates on clinical process improvement projects and initiatives, supporting departmental, divisional, and corporate quality goals and priorities.
Facilitate Inspection Readiness program to include inspection readiness training and facilitate/coordinate Mock BIMO inspections.
Manage/coordinate BIMO sponsor inspection, and other regulatory agency sponsor inspections of offices.
Preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
Clinical Quality System: Support to the Clinical organization in meeting
Quality system requirements: Support Clinical and QS team during External Regulatory/Notified Body audits.
CAPA program; assessing internal noncompliance working cooperatively with CAPA owners providing quality input.
Independent Auditing: Plans, schedules, and conducts external quality audits to assure that clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
Plans, schedules, and conducts internal quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
Plans schedules and conducts clinical vendor assessments, qualification and periodic. Review, revise, update and maintain Clinical AVL
Communicates observations to clinical investigators, clinical program managers, directors, and management.
Contributes to the development of audit procedures and processes.
Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
Demonstrated knowledge of GCP, Clinical compliance and Auditing within an FDA-regulated and global environment. Solid understanding of global clinical development and robust experience on GCP-ICH, audits and inspections. Clinical Compliance, QMS principles, GCP/ICH guidelines.
Experience with Clinical Operations Governance and Execution (in & outsourcing) Phase 1 to 3 Clinical Trial Management. Experience with electronic trial systems, quality management systems, eCRF systems preferred
Excellent organizational and time management skills with a strong attention to detail. Strong interpersonal communication skills; acts with urgency and passion. Enjoys helping others Ability to work both independently and with a team in a collaborative, fast-paced setting.
Lean Six Sigma certified or in progress or demonstration of keen operational efficiency skills
Drive Innovation and Digitization in the Pharmaceutical Quality arena provide tangible examples
Up to 25% Travel is required for this position
Bachelor's degree in life science and 8 plus years of experience in regulated worldwide clinical drug, biologic or device development. Applicable MS highly desired
Clinical Quality Assurance with minimum of 2 years in people management preferred.
Advanced degree(s) preferred
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.