Associate Director, Global Quality Audit

Daiichi Sankyo US • Basking Ridge, NJ

21d

About The Position

Accountable to organize and directs an audit universe for GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. Establish lessons learned from audits/inspections to drive continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Support/ lead and or co lead due- diligence assessments of GMP facilities and or CMOs as deemed necessary. Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent will have to demonstrate ability to support the transformation of the organization into a learning and proactive organization through lessons learned from audits, assessments, inspections, metrics, deviations and or process improvements. Ensure adequate QA oversight of the GMP audit programs of contract manufacturing sites/ warehousing/ specialty pharmacy as necessary. Ensure effective collaboration with DS affiliates to promote a culture of quality that drives performance and teamwork.

Requirements

• Bachelor's Degree in scientific discipline required
• Must have at least 7 or more years of either pharmaceutical industry or biological operations expertise including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit, or equivalent experience.
• Must have expertise with various pharmaceutical dosage forms with strong preference on biologics
• Must have demonstrated solid understanding of quality management and continuous process improvement principles including global cGMP requirements
• Ability to travel up to 30% travel both domestic and global required.

Nice To Haves

• Master's Degree or other advanced degree preferred
• Certifications for Pharmaceutical Quality Engineering, Auditing and/or Quality Management preferred

Responsibilities

• GMP Audit: Support the completion of GMP audit and vendor qualification program creating audit plans, organizing audit schedule, monitoring the completion of proposed CAPA plans and managing metrics related with audits and vendor performance. Responsible to complete on paper basis audit and to monitor vendor performance management program. Support the issue and communication of audit plans, agenda and report to the vendors and for collecting the necessary answers in appropriate time. Responsible also for properly storage and retain all the records in order to ensure the traceability of audit process. Participate in the development of GMP audit certification program to ensure adequate qualification of auditors per regulatory expectations.
• Risk Management and Vendor Performance: Responsible to ensure the risk management activities completion for vendors and to periodically review vendor performance in order to ensure the management in accordance with local procedures and standards. Accountable to track this information on QA electronic system and to communicate to the stakeholders if the acceptance criteria for each vendor is reached as per internal procedures.
• Audit Intelligence and Metrics: Accountable to create and maintain database information about each vendor and supplier Quality status defining, evaluating and communicating periodically metrics to DSI QA involved functions and DS Global QA organization. Demonstrate engagement with GMP QA quality managements, Pharma Product QA teams and other QA functions as deemed necessary to ensure communication of metrics, lessons learned from audits and to ensure that are used for continuous process improvement and stakeholder management. Support the establishment of setting up standards for pre-selection of vendors and/or suppliers to meet DS company expectations and to support the strategical assessment of suppliers prior to selection and contract.
• Development of Standards and Procedures (SOPs) and Training: Responsible for authoring procedural documents that set strategy in QA GMP Audit processes for contribution of Quality Management System (QMS) establishment processes in collaboration with GMP Quality System function. Supports the development and implementation of key global/regional QA GMP Standards, Procedures and Instructions. Responsible for providing support to training activities for QA GxP related functions in best auditing practices in order to ensure the inspection readiness level of each site and maintain a capacitation program for GMP staff in best audit skills.
• Cross-Functional Team Participation: May collaborate with QA GMP organization participation in local, regional and global audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, standards definition, training and capacitation program for GMP QA Auditors. Interacts with local, regional and global stakeholders sharing reports and related information about audits, harmonizing procedures and templates and contributing to the efficiency of audit program
• Communication: Communicate clearly and in a timely manner with suppliers in order to address and identify proactive solution for business contribution, resolves complex issues and difficult stakeholder management situations. Responsible for evaluating the impact and properly communicate with management in order to proactively recognize risks and provide good solution Create an atmosphere of trust, integrity and ethics.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees