Audit Manager, QA in Basking Ridge, NJ at DSI

Date Posted: 4/3/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Accountable for manages and oversees 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. Create and share lessons learned from audits/inspections to drive continuous improvement in collaboration with other QA functions and/or applicable stakeholders. Responsible to support QA Audit functions in order to correct retain all the documentation related with audit or inspections activities on timely manner and provide the records when necessary. Responsible for creating and organize audit schedule plans and to maintain a strong communication with vendors, collecting information and fill into supplier risk assessment program and support authoring and review templates, procedures and reports. Accountable for tracking and handle the actions from CAPA and for monitoring vendor performance.

The incumbent will ensure adequate QA oversight of the GMP audit programs of contract manufacturing sites/ warehousing/specialty pharmacy as necessary. Ensure effective collaboration 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.

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.

CAPA Management: Responsible for review, track and ensure the completion for CAPA plans provided by vendors as part of monitoring activities for Vendor Qualification Program.

GMP Inspection Readiness: May participate with the sites before, during and after regulatory inspections to ensure acceptable results and on time delivery of CAPAs from regulatory inspections. Assure that all observations made during audits and regulatory inspections are addressed in a timely manner and meet all company and regulatory requirements and that the responses to the regulators show the company in a true and positive manner. Support conducting mock and/or pre-approval inspections at DS manufacturing sites or contract manufacturers.

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.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor’s Degree in scientific discipline is required. Master’s degree level preferred.

Minimum 5 years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit. Experience with various pharmaceutical dosage forms is desired.

Certifications for Pharmaceutical Quality Engineering, Auditing and/or Quality Management (Preferred but not required)

Solid understanding of quality management and continuous process improvement principles including global cGMP requirements.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.