The Associate Director, Quality Assurance will be responsible for the designing, establishing, maintaining and executing a robust GCP compliance program, including conduct and oversight of audits, to ensure consistent adherence to relevant regulations, guidelines, strategy and procedures.

This Associate Director, Quality Assurance 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. As necessary will conduct pharmacovigilance audits of Shionogi PV vendors.

RESPONSIBILITIES

• Audit clinical trials including clinical investigator site audits, clinical vendor audits, directed audits, and other special audits (such as CSV) and assessments to assess quality level and compliance with applicable GCP regulations in support of Shionogi clinical programs, either as Lead or as part of a co-auditing team.
• Serve as QA representative on multiple active clinical development projects.
• Provide guidance and recommendations to the Clinical Development department by serving as the GCP subject matter expert and providing high standard of quality guidance, advice and support on GCP regulatory compliance matters and participate in and support Regulatory Agency inspections as required.
• Serve as resource for interpretation and evaluation of GCP and Pharmacovigilance compliance issues for Clinical Development, Quality Assurance, and Regulatory Affairs.
• Create formal audit reports and identify critical audit findings to senior management, including recommendations for corrective action and/or regulatory reporting, if necessary.
• Conduct internal audits of systems and processes.
• Conduct pharmacovigilance audits of PV vendors.
• Coordinate PAI readiness activities.
• Review and approve audit responses.
• Ensure effective closure, by working with “auditees” to ensure comprehension, development and execution of corrective/preventive action with regard to any non-conformities cited during audits.
• Assist in preparing the audit schedule for the year.
• Support the conduct of global GCP or PV audits led by SBV or SHQ as required.
• Develop/modify audit checklists as regulatory requirements change.
• Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups.
• Support the development and delivery of GCP training programs.
• Support of other QA projects as needed.
• Will travel up to 25% - domestic and international.

REQUIREMENTS

• BA/BS in the life sciences required.
• Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years of GCP and GVP audit experience.
• Background should include intercultural awareness and ability to work in an international environment and on cross functional teams.
• Thorough knowledge of ICH E6R2 and ICH E8 and FDA Guidelines as well as any updates, and GCPs including regulatory requirements for the conduct of clinical development programs.
• Excellent oral, written and verbal communication skills.
• Appropriate technical skills in GCP and Pharmacovigilance compliance, experience in electronic QMS is necessary.
• Proven interpersonal skills including good negotiating skills.
• Hybrid work arrangements will allow work from home combined with your presence on-site 2-3 days/week (when not traveling) at our US HQ 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.

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.