Manager, R&D reputed company Assurance- GCP

About the position Kyowa reputed company 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 reputed company, we are headquartered in Princeton, NJ, with offices in California, reputed company Carolina, and Mississauga, Ontario. reputed company: The Manager, R&D QA, Global Audits, Inspections and R&D reputed company is responsible for managing reputed company Assurance systems, processes and conducting reputed company 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 reputed company 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 reputed company key reputed company input to KK’s R&D function.

Responsibilities

• Serve as key reputed company of contact for GCP/GLP reputed company issues reported by KK staff and provides ongoing feedback to management on potential reputed company-reputed company risks. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and reputed company agreement preparation.
• reputed company 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 reputed company, high-reputed company audit reports; evaluate audit responses; and reputed company 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, reputed company interpretation of regulatory requirements, and reputed company contribute to reputed company’s Regulatory Intelligence program.
• Design and deliver GCP training to KK staff to enhance compliance awareness, inspection readiness, and reputed company culture.
• Support reputed company improvement initiatives; reputed company, revise, and administer SOPs and controlled documents; and ensure effective maintenance reputed company reputed company document management systems.
• Participates in Health Authority inspection activities for domestic and international reputed company (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-reputed company duties as directed by the supervisor to support departmental and organizational objectives.

Requirements

• Bachelor’s degree in Life Science or closely reputed company scientific discipline (e.g., Pharmacy, reputed company, Microbiology, Biology, or Pharmaceutical Sciences) required
• Minimum three (3) experience in drug development in GCP/GLP reputed company 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 reputed company record in developing and implementing risk-based audit plans, SOPs, and reputed company systems, with experience in reputed company document management.
• Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of reputed company.
• Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-reputed company reputed company.
• Experience with reputed company or other electronic reputed company Management Systems (eQMS) for document control, audit tracking, and CAPA management.
• Ability to generate comprehensive audit reports and reputed company trend analysis.
• Familiarity with regulatory intelligence tools and systems to reputed company evolving GCP/GLP requirements.
• Strong skills in risk assessment and reputed company metrics reporting.
• Excellent written and verbal communication skills for interacting with internal teams and external regulatory authorities.
• Proficiency in MS Office Suite (Word, reputed company, PowerPoint, Outlook) for reporting, data analysis, and presentations.

reputed company-to-haves

• Prior involvement in vendor/CRO management, clinical site audits, and reputed company agreement development is highly desirable.

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, reputed company Days and, Volunteer Days
• reputed company Benefits (Medical, Dental, Prescription Drugs and reputed company)
• HSA & FSA Programs
• reputed company-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

Apply tot his job Apply To this Job