The Senior Manager, GPV Compliance & Business Management will support the leads of Global PV Audit & Inspection readiness (AIR) activities and Global PV Corrective Action Preventative Action (CAPA) and Deviation for the processes managing and maintaining compliance. This role will work collaboratively with other stakeholders from Global Pharmacovigilance (GVP) groups, Affiliate PV Coordination Group (APVC), Global Quality Management (GQM), the Global QPPV Office and Regional Pharmacovigilance Heads as required to ensure compliance across the GPV organization. As required, this colleague will work with other CBM leads to align on the other activities cross the sub-functions within CBM, such as compliance, PV SOPs, etc.
Job Description
• Provide support to the GPV Audit & Inspection Readiness Lead for the management and oversight of PV related audits and inspections, including but not limited to the planning and conducting readiness activities/training.
• As the Sr. Manager for audits and inspection, support the GPV Audit & Inspection Readiness Lead for audits and inspections by providing support and guidance to SMEs, including management of backroom and front room.
• Work with APVC and Global Quality to provide support to local affiliates for preparation and expectations of audits.
• Work with Global Quality, Head of CBM, and the Global QPPV to confirm Company Main Contact (CMC) details for audits.
• Support the GPV Audit & Inspection Readiness Lead on QC of documents to be shared for Audits/inspections.
• Participate in regular meetings with Global Quality for alignment as required.
• Support the Global PV CAPA & Deviation lead in the management of PV related Audit Finding Responses and, in the development, and execution of corrective actions/preventative actions (CAPA) plans.
• Development, management and tracking of CAPAs relevant to PV, evaluation/review of PV Audit/Inspection findings, as required.
• Collaborate with Otsuka departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and support regulatory inspections as needed.Provide guidance and support for CAPA implementation and documentation.
• Facilitate discussions with CAPA owners to drive completion of investigations, root-cause analysis, impact analysis, and closure of CAPA.
• Support the Global PV CAPA & Deviation lead to develop, coordinate and ensure CAPA training is provided and maintained for relevant personnel.
• Review CAPA records at different phases of the process to assess CAPA activities, documentation and to assure compliance with CAPA procedure.
• Assist and facilitate closure of CAPAs and internal and external audits in a timely manner.
• Collaborate with GQM to ensure timely audit and inspection responses for the PV function and appropriate ownership of CAPAs by PV subject matter experts (SMEs) worldwide.
• Assist with coordination and management of PV related Deviations, Temporary Change Controls (TCC), and Standalone CAPAs.
• Attend regular meetings with GQM, Audit & Inspection readiness team to align processes, best practices, and escalations, as applicable.
Additional activities:
• As required, this colleague will work with other CBM leads to align on the other activities across the sub-functions within CBM, such as compliance, PV SOPs, etc.
• Attend Global/Regional PV meetings as required.
• Assist with gathering and evaluation of metrics for PV CAPAS/Deviations at Global Meetings• May be assigned to lead or assist with special projects or process development.
• Collaborate with the Regional PV offices for process improvement initiatives and CAPAs identified by the Regional PV offices.
• Liaise with other affiliates and business units to keep them appraised of safety activities and to provide input on strategic decisions and to ensure that activities are performed by those functions adequately address PV requirements.
• Participate in the root cause analysis, identification and investigation of non-adherence to PV requirements.
Qualifications
Required
• Minimum 4 years PV Compliance or Quality Management experience in the pharmaceutical industry
• Bachelor’s degree
• Expertise in Good Pharmacovigilance Practice (GPvP), experience in Pharmacovigilance, drug safety or related areas
• 20% Travel
• Excellent knowledge of ICH, US & EU regulations, and requirements for pharmacovigilance
• Strong knowledge of regulatory inspections with the ability to handle all situations that may occur and determine appropriate strategies and courses of action
• Experience in coordinating PV audits in the pharmaceutical industry
• Solid background and experience in pharmaceutical quality system management (GxP)
• Strong project management, interpersonal communication, and presentation skills• Excellent written and verbal communication with internal and external customers• Excellent planning and organizational skills• Strong team working and leadership skills• Ability to plan, prioritize and delegate work• Responsible, flexible, and accountable with proactive approach
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer:
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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
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What We Do
There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
