Quality Manager, Global Quality Management

Description of Role

The main purpose of this role is to support the Global Quality Management team with an emphasis on GxP audit coordination.  In addition to these activities, the role would include supporting the Global Quality Management team with inspection readiness/ management activities, and other QA activities as required.

Key Responsibilities and Decision

In close collaboration with the Director, Global Quality Audit Management:

Audit Related Activities

• Coordinate, support, and manage GxP Audit activities

Organize audit preparation meetings

Track Audit scheduling and keep Master Audit Schedule tracker up-to-date

• Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
• Assist the audit programme with planning, communicating, documenting, and executing the GxP audit strategy
• Support the Global Quality Management team in risk assessment activities
• Support the preparation and review of Audit Reports

Otsuka Companies’ Quality System

• Support the continuous improvement and enhancement of the Quality System (e.g., Trackwise, ACE, etc.)
• Collaborate with the respective Functional Areas representatives as required for audits
• Foster a continuous improvement mentality within Otsuka
• Support the establishment and maintenance of the required Audit/Inspection Documentation
• Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution

Regulatory Inspections

• Support the preparation for inspections
• Support the Global Quality Management teams with the responses to Regulatory Authorities
• Support the review and assessment of corrective and preventive actions (CAPA)
• Manage ACE Chat, Scribe Notes and other assigned activities

JOB SCOPE (key facts)

• Located in Princeton, NJ or Rockville, MD
• The employee will report to Director, Audit Program Management, Global Quality Management
• The employee should be able to travel domestically and/or internationally at short notice as needed for supporting inspections/audits.

QUALIFICATIONS/ EXPERIENCE

• BS degree in the sciences
• 2 or more years in multi-national biopharmaceutical industry that includes performing GxP audits, or clinical monitoring or inspection readiness activities
• Experience in CAPA management
• Exposure to regulatory inspections

COMPETENCIES

• Knowledge of regulations and guidance regarding clinical development
• Understanding of Good Clinical Practice processes
• Understanding of audits and CAPA management
• Ability to work independently and as part of a quality team supporting the lifecycle of audits
• Well versed with MS Office (advance users in Excel & PowerPoint preferred). Knowledge of TrackWise, ACE, Veeva desirable
• Excellent communication skills (written and oral) in English
• Problem solving and resolution skills
• Analytical and creative thinking
• Understanding of being risk based focused and prioritizing work based on Risk Management methodologies

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $107,718.00 - Maximum $161,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or