Manager, R&D Quality Assurance- GCP

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 North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

Summary:

The Manager R&D QA Global Audits Inspections and R&D Quality is responsible for managing Quality Assurance systems processes and conducting internal and external audits and reviews training and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KKs R&D function.

Essential Functions:

Serve as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks. Involvement in clinical trials includes but is not limited to independent review and approval of deviations and CAPAs GCP guidance and quality agreement preparation.
Perform and report assigned GCP/GLP audits of KK studies including clinical investigator sites vendors/CROs internal systems/processes and clinical data/documents as applicable.
Prepare timely high-quality audit reports; evaluate audit responses; and oversee CAPA development adequacy implementation and tracking in accordance with KK standards.
Maintain expert-level knowledge of global GCP/GLP regulations and industry expectations. Serve as a subject matter expert to KK staff provide interpretation of regulatory requirements and actively contribute to the companys Regulatory Intelligence program.
Design and deliver GCP training to KK staff to enhance compliance awareness inspection readiness and quality culture.
Support continuous improvement initiatives; develop revise and administer SOPs and controlled documents; and ensure effective maintenance within quality document management systems.
Participates in Health Authority inspection activities for domestic and international projects (as applicable).
Provides input to the annual risk-based audit plan schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
Undertake other QA-related duties as directed by the supervisor to support departmental and organizational objectives.

Requirements:

Education
Bachelors degree in Life Science or closely related scientific discipline (e.g. Pharmacy Chemistry Microbiology Biology or Pharmaceutical Sciences) required

Experience
Minimum three (3) experience in drug development in GCP/GLP Quality Assurance including hands-on experience in auditing CAPA management and deviation review.
Demonstrated knowledge of global regulatory requirements including EMA FDA MHRA ICH and other applicable standards with proven ability to interpret and apply them in operational settings.
Experience supporting Health Authority inspections including preparation participation and follow-up actions.
Proven track record in developing and implementing risk-based audit plans SOPs and quality systems with experience in quality document management.
Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
Exposure to global cross-functional collaboration with clinical regulatory and operational teams on QA-related matters.
Prior involvement in vendor/CRO management clinical site audits and quality agreement development is highly desirable.

Technical Skills
Experience with Veeva or other electronic Quality Management Systems (eQMS) for document control audit tracking and CAPA management.
Ability to generate comprehensive audit reports and perform trend analysis.
Familiarity with regulatory intelligence tools and systems to track evolving GCP/GLP requirements.
Strong skills in risk assessment and quality metrics reporting.
Excellent written and verbal communication skills for interacting with internal teams and external regulatory authorities.
Proficiency in MS Office Suite (Word Excel PowerPoint Outlook) for reporting data analysis and presentations.

Working Conditions:

Requires up to 20% domestic and international travel

The anticipated salary for this position will be$155000 to $170000. 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 Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers 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.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

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 .

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.

#LI-TT1 #Hybrid #Princeton