Manager, GMDP Auditor

Kyowa Kirin North America•Princeton, NJ

5h•Hybrid

About The Position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Manager, GMDP Auditor is responsible for planning and conducting GMDP audits in accordance with Kyowa Kirin’s standards and applicable regulatory requirements. This includes audits of external suppliers (e.g., CDMOs, drug substance manufacturers, batch release sites, warehousing and transportation providers, distributors), internal manufacturing sites, commercial affiliates, and other relevant entities as applicable. The role covers routine, for-cause, and due diligence audits to ensure compliance and quality oversight.

Requirements

Bachelor’s degree in a Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required. Advanced degree and/or relevant professional certification (e.g., ASQ Certified Quality Auditor or equivalent) preferred.
Minimum of five (5) years of experience in the pharmaceutical or biopharmaceutical industry, with at least two (2) years in Quality Assurance and/or GMP/GDP auditing within a regulated environment.
Demonstrated experience conducting GMP and/or GDP audits (internal and/or external), including supplier audits and audit report writing.
Experience in aseptically manufactured parenteral products within a commercial manufacturing environment is required.
Experience working with or auditing contract manufacturing organizations (CDMOs) and other external suppliers is preferred.
Experience in CAPA management, including review, follow-up, and effectiveness verification.
Exposure to or participation in Health Authority inspections (e.g., FDA, EMA, MHRA, or other international regulatory bodies) is preferred.
Experience working in a global, cross-functional environment, supporting risk-based decision-making and quality oversight activities.
Strong knowledge of GMP and GDP regulations and guidelines, including U.S., EU, and other international requirements.
In-depth understanding of pharmaceutical manufacturing processes, particularly sterile/aseptic manufacturing, as well as oral solid, liquid, and semi-solid dosage forms.
Solid understanding of pharmaceutical quality systems, including deviation management, change control, CAPA, complaint handling, and supplier quality management.
Ability to perform risk assessments and apply risk-based audit planning principles.
Strong audit skills, including audit preparation, interviewing techniques, report writing, and follow-up management.
Proficient in the use of Quality Management Systems (QMS) and electronic document management systems (e.g., Veeva,).
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Strong analytical, written, and verbal communication skills, with the ability to clearly document and present audit findings.
Requires up to 50% domestic and international travel

Responsibilities

Lead and conduct GMP/GDP audits globally as Lead Auditor or Co-Auditor, including but not limited to external suppliers (e.g., CDMOs, drug substance manufacturers, batch release sites, warehousing and transportation providers, distributors), other manufacturing service providers, internal manufacturing sites, commercial affiliates, and other applicable entities, in accordance with company standards and regulatory requirements.
Perform GMP/GDP due diligence audits to support business development activities, supplier qualification, and risk-based decision-making.
Evaluate audit responses and oversee CAPA management, including review and approval of corrective and preventive action plans, and ensure effective tracking, closure, and documentation of audit findings in alignment with Kyowa Kirin’ standards.
Provide input to the annual risk-based audit plan, Schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
Identify and communicate quality and compliance risks to management, providing timely and actionable feedback to support informed decision-making.
Participate in Health Authority inspection activities, both domestic and international as applicable, including preparation, support during inspections, and follow-up activities.
Supports (and may lead) continuous including development, revision, and maintenance of SOPs and other controlled documents within the quality document management systems.

Benefits

401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards