This Contractor in the Clinical QA Group is responsible for maintaining and executing a robust GCP & GVP compliance program, and will conduct and have oversight of audits to ensure consistent adherence to relevant regulations, guidelines, company policies, and procedures as well as contracts and agreements.
This Contractor in the Clinical QA Group will establish and maintain strong relationships with internal and external stakeholders to ensure that quality standards are adhered to at all times and collaborate with global GCP/PV QA members to ensure the initiation and completion of global initiatives.
In addition, this Contractor in the Clinical QA Group will provide a high standard of quality guidance, advice, and support for GCP & Good Pharmacovigilance practices (GVP) and regulatory compliance matters to include participating in and supporting health agency inspections as required.
RESPONSIBILITIES
Responsible for maintaining and executing robust GCP & GVP compliance programs for both Local and Global GCP & PV Audit Programs -- including proper management of audit schedules and execution of audits, ensuring compliance with regulatory standards, company policies, and procedures.
Ensure that timelines are met, that reports are completed and that appropriate CAPAs are assessed.
Contribute to the development of local quality management systems, including contributing/writing policies/procedures.
Partner with Quality Systems group to develop and enhance the GxP Quality Management System, looking for cross-GxP efficiencies and synergies.
Manage and identify potential systemic compliance risks including Investigations of deviations and monitoring of corrective actions and preventative (CAPA) relating to non-compliance issues and findings.
Manage and perform GCP investigations regarding Quality Issues and Misconduct Investigations including Serious Breaches.
Participate in the streamlining of existing PV related documents or create when necessary, e.g. PSMF.
Establish and maintain GCP & GVP regulatory inspection readiness; participate in preparation and execution of health agency inspection activities.
Support the development and delivery of GCP & GVP training programs.
Lead development of process improvement strategies and tools related to GCP & GVP compliance efforts.
Assist with Clinical and Pharmacovigilance activities (e.g. deviations, CAPAs) when requested.
Ensure key performance indicators for GCP & GVP are set-up, maintained, performed and reported to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements.
Maintain strong knowledge of regulations, company procedures, auditing, and quality principles.
Facilitate the sharing of best practices and help to drive continuous improvement and compliance.
Continuously build and innovate in all aspects of GCP & GVP compliance.
Perform other quality or compliance related duties as needed.
REQUIREMENTS
Bachelor’s degree in a scientific field or relevant experience.
5+ years of related experience in the pharmaceutical industry.
Solid understanding of GCP & GVP, knowledge of PMDA/EMA/FDA, ICH and applicable regulations.
Proficient in Microsoft Office Applications (Excel, Power Point and Word).
Ability to travel up to 40% of the time – domestic and international.
Extensive knowledge of applicable legislation and practical hands-on experience in GCP & GVP.
Comprehensive understanding of pharmaceutical regulatory requirements and impact on the various functions within the business.
Familiarity with database and GLP audit practices.
Ability to identify proactively and anticipate risk of non-compliance in a complex environment.
Ability to develop and manage efficient and effective compliance systems.
Excellent planning and organizational skills.
Ability to project manage, set clear strategic goals, align priorities and lead multiple tasks/activities within a virtual/remote team to successful business conclusion
Strong decision-making skills and ability to use independent judgment to quickly set priorities, solve problems and resolve conflict.
Excellent oral and written communication skills and ability to adjust communication to different target groups.
Good working knowledge and comprehension of written English ( knowledge of Japanese is a plus).
Exceptional attention to detail.
Inter-cultural awareness, proven ability to work in an international environment and cross functional team.
Ability to work independently with minimal supervision.
Ability to effectively multi-task, be proactive and self-motivate.
Ability to work to tight deadlines, with incomplete information, handle unexpected events and work under the pressure.
Good analytical and judgment capabilities to understand/analyze/synthesize and communicate.
Proven ability to influence senior leaders within the organization on matters of importance.
Customer-focused, good interpersonal skills, assertive, team spirit and coaching skills. Able to delegate, but committed to providing proactive support, to the business and teams to achieve successful outcomes.
A team player able to work with and through others; someone people proactively seek out for help, guidance and advice.
Ability to travel via automobile, train and airplane.
Should live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
Please be aware that Shionogi Inc. mandates COVID-19 vaccination of all employees and contractors regardless of work location. Accommodations may be made in accordance with applicable law.
DISCLAIMER
The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice.
EEO
Shionogi Inc. is an equal opportunity/affirmative action employer.
All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.
It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
