The Associate Director GCP/GVP Quality Assurance provides senior-level quality oversight for Shionogis clinical development and pharmacovigilance activities ensuring compliance with ICH FDA EMA PMDA MHRA and other global regulatory requirements. Serving as the QA representative to assigned study teams and an advisor to PV this role evaluates processes practices documentation and study plans to identify compliance risks and drive resolution of quality issues.

The Associate Director GCP/GVP Quality Assurance provides senior-level quality oversight for Shionogis clinical development and pharmacovigilance activities ensuring compliance with ICH FDA EMA PMDA MHRA and other global regulatory requirements. Serving as the QA representative to assigned study teams and an advisor to PV this role evaluates processes practices documentation and study plans to identify compliance risks and drive resolution of quality issues.

The incumbent plans conducts and manages risk-based audits of investigator sites CROs vendors and internal processes ensuring timely and effective CAPA implementation. They support regulatory inspection readiness provide regulatory interpretation to mitigate risks and address potential compliance concerns and contribute to the maintenance of the Pharmacovigilance System Master File (PSMF).

Working with cross-functional partners and external vendors the Associate Director drives risk mitigation strategies to safeguard patient safety data integrity and product quality. The role also contributes to the development review and enhancement of QA standards policies and training materials to strengthen Shionogis quality system and culture.

Operating with a high degree of independence the Associate Director influences across functions and geographies while remaining hands-on in execution of audits inspections and quality investigations.

Responsibilities

• Provide quality oversight of clinical trial operations and PV to ensure GCP and GVP regulatory compliance with ICH FDA EMA PMDA MHRA additional local regulatory requirements and global guidance.
• Serve as QA Representative to assigned clinical study teams and advisory to PV.
• Evaluate clinical trial documentation processes and study plans to ensure alignment with Shionogis expectations and regulatory requirements.
• Provide interpretation and evaluation to clarify or resolve GCP and GVP compliance issues for clinical PV cross functions impacting clinical trial and PV operations.
• Develop and ensure the GCP and GVP audit plan(s) is(are) executed via a risk-based approach and maintained to stay current as part of quality oversight.
• Collaborate with the Global GVP QA teams in support of the QPPV Office to maintain PSMF up to date.
• Plan conduct and/or manage internal processes systems and external audits including but not limited to audits of clinical investigator sites CROs vendors phase I units labs business or licensing partners distributors.
• Follow up on audits ensure proper closure with effective CAPAs in a timely manner.
• Active in preparing Shionogis readiness for GCP and GVP regulatory inspections.
• Provide regulatory inspection support.
• Manage quality investigations deviations root cause analysis and the implementation of Corrective and Preventive Actions (CAPAs). Evaluate the effectiveness of CAPAs through timely closure.
• Act as a key Quality contact for external vendors as assigned develop and execute Quality Agreements as applicable.
• Work with internal cross-functional teams impacting either Clinical or PV to assess risks associated with vendors and implement risk mitigation strategies to ensure product quality study compliance data integrity and patient safety.
• Support the development review and update of Shionogi standards for QA and standards impacting Clinical and PV.
• Engage in providing GCP or GVP feedback on relevant training materials for implementation.
• Other duties as assigned.

Minimum Job Requirements

• BA/BS in life sciences a scientific technical discipline or a related field.
• 7 years of progressive experience in Quality Assurance Compliance or Regulatory roles supporting GCP and/or GVP in clinical development and pharmacovigilance.
• Strong working knowledge of global GCP/GVP regulations and guidelines (ICH FDA EMA MHRA PMDA and other local authorities).
• Strong working knowledge of global GCP/GVP regulations and guidelines (ICH FDA EMA MHRA PMDA and other local authorities).
• Demonstrated experience in planning conducting and/or managing audits of investigator sites CROs vendors and internal processes; direct experience supporting global regulatory inspections.
• Solid background in CAPA management root cause analysis and vendor quality oversight including execution of Quality Agreements.

Competencies

• Deep understanding of compliance frameworks with the ability to interpret complex regulatory requirements and translate them into practical solutions.
• Strong analytical and decision-making skills to evaluate issues identify risks and recommend corrective actions.
• Effective at working cross-functionally and with external partners/vendors; capable of influencing without direct authority.
• Effectively manages investigations and root cause analyses drives timely and sustainable CAPA implementation and ensures robust vendor quality oversight through execution of Quality Agreements and risk mitigation strategies.
• Excellent written and verbal communication skills with the ability to articulate regulatory expectations and quality standards to diverse audiences.
• Skilled at managing multiple priorities audits and projects simultaneously within agreed timelines.
• Operates with a high degree of autonomy demonstrates judgment in escalating issues and models accountability in execution.
• Strong interpersonal awareness adaptability and resilience when operating in ambiguous or changing environments.

Other Requirements

• Ability and willingness to travel up to 25% of the year both domestically and internationally.
• Must live a commutable distance to our US Corporate Headquarters in Florham Park NJ. Office presence required 50% per month at least 2-3 days per week.

Additional Information

To be considered for this position you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.

The base salary range for this full-time position is $160000 - $190000. 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.

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.

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