Senior Manager, GPV Compliance & Business Management (CBM)

Posted 7 Days Ago
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Princeton, NJ
Senior level
Internet of Things • Pharmaceutical
The Role
The Senior Manager supports Global PV compliance through audits, CAPA management, and collaboration with stakeholders to uphold regulatory standards.
Summary Generated by Built In
Job Summary
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 employerAll 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 disabilityYou can request reasonable accommodations by contacting Accommodation Request. 

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Top Skills

Eu Regulations
Good Pharmacovigilance Practice
Ich
Us Regulations
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The Company
HQ: Princeton, NJ
3,516 Employees
On-site Workplace

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.

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