Sr. Manager, GCP/GVP

Shionogi Inc. (U.S.); Florham Park (NJ); Hybrid; USD 135,000 - 165,000; Full time

Job summary

Shionogi Inc. (U.S.) is seeking a GVP/GCP QA lead to support and maintain a global PV quality program, collaborating with Global QA teams to ensure regulatory compliance with FDA, EMA, MHRA, PMDA and ICH, including PV systems and PSMF.

The role develops, implements, and maintains QMS, leads audit strategies, supports regulatory inspections, travels up to 15%, and works in a hybrid model at the Florham Park, NJ headquarters.

Qualifications

• BA/BS in life sciences or related field.
• 6+ years in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role.
• Working knowledge of GVP/GCP regulations (ICH, FDA, EMA, MHRA, PMDA).

Responsibilities

• Develop, implement, and maintain GVP/GCP QMS.
• Prepare for regulatory inspections and develop/audit strategies.
• Ensure ongoing compliance with GVP/GCP regulatory requirements and maintain PSMF.
• Manage CAPAs and effectiveness checks.

Skills

Attention to detail

Team player

Agile

Communication skills

Critical thinking

Problem solving

Education

Bachelor's degree in life sciences

Job description

This role will support and maintain a robust GVP and GCP compliance program across the organization, with GVP QA as the primary responsibility and GCP QA as the secondary responsibility. This role will collaborate with the Global GVP/GCP QA teams to provide quality oversight of pharmacovigilance (PV), business/licensing partners, distributors, clinical studies, CROs/vendors, ensuring regulatory compliance with FDA, EMA, PMDA, MHRA, ICH, additional local requirements as applicable, and other global guidelines.

Responsibilities

• Engage in the development, implementation, and maintenance of the GVP and GCP Quality Management System (QMS), ensuring compliance with worldwide and local PV regulations.
• Actively engage in preparedness for the regulatory inspections, e.g., FDA PADE inspection. Collaborate with the Global QA teams in the development and execution of audit strategies, manage, oversee or conduct audits.
• Ensure ongoing compliance with relevant GVP and GCP global and local regulatory requirements and guidelines, including management and support in maintenance of Pharmacovigilance System Master Files (PSMF).
• Manage compliance with risk assessments, facilitate root cause analysis, and ensure the implementation and effectiveness of Corrective and Preventive Actions (CAPAs) and effectiveness checks.
• Act as a primary GVP Quality contact of all GVP related matters and GCP Quality contact as assigned, collaborating with cross-functional teams and internal departments.
• Drive the continuous improvement of GVP and GCP quality systems and procedures.
• Other duties as assigned.

Minimum Job Requirements

• BA/BS in life sciences, a scientific, technical discipline, or a related field.
• Minimum of 6 years of experience in a GVP/GCP QA/quality/compliance role or regulatory inspectorate role supporting PV and/or clinical study teams.
• Working knowledge of GVP/GCP regulations and guidelines, including ICH, FDA, EMA, MHRA and PMDA requirements.

Competencies

• Strong attention to detail, team player, agile, excellent communication skills, strong critical thinking skills, and effective problem-solving abilities.
• Excellent project management, organizational, and leadership skills to manage cross-functional teams and multiple projects simultaneously.
• Capable of operating in an ambiguous environment.
• Capable of operating independently with a leveled understanding of decision making.

Other Requirements

• Ability and willingness to travel up to 15% of the year both domestically and internationally.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Hybrid office presence is required at 50% of the time per month.

Additional Information

The base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), 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 for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are 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 use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to [e-mail].