Manager GMDP Auditor

Job Description

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.

Essential Functions:

•    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.

Requirements:

Education

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.

Experience

•    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.

Technical Skills

•    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.

Working Conditions:

Requires up to 50% domestic and international travel

The anticipated salary for this position will be $____ to $____.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) ²⁰¹⁶⁄₆₇₉ (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

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Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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