Manager, QA GCP in Basking Ridge, NJ at DSI

Date Posted: 2/1/2021

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 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 cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:
Under the direction of Head of QA GxP Audits ensures all assigned audits are managed, audit reports issued as per pre-defined timelines and mitigation and remediation activities related to the GxP audits are addressed throughout the audit cycle. Contributes to identifying which programs require prioritization for audits based on applied risk methodology. This position interacts across GxPs and is pivotal in ensuring that the organization is in a perpetual state of compliance. May be tasked to work with integrity and compliance in assessing or addressing internal corporate audit needs for the organization. Accountable for ensuring lessons learned from audits and inspections are provided to stakeholders and throughout QA team to ensure end-to-end organizational awareness and continuous improvement. Performs audits across GxPs as assigned. May support GMP facility audits, specifically, as it relates to IMP relevant activities. General awareness and understanding of systems and tools used for clinical trials and ability to assess processes and ensure its purpose (limited to validation activities). Together with QA Audit Planner and Risk Management, ensure inspection readiness programs are in place and support regulatory inspections in collaboration with other QA functions and stakeholders. In collaboration with QA Standards and Procedures, may participate in continuous improvement initiatives stemming from lessons learned from audits and that may involve authoring procedural documents or enhancements. Proactively identifies areas in need of process improvement initiatives and ensures prompt communication to QA R&D team. Ensures adequate audit strategy across boundaries and may be tasked to support audit activities within DS Group and/or affiliates. Accountable for engineering relevant training activities to support lessons learned and ensure regulatory understanding and impact stemming from audits and inspections. Ensure adequate issue escalation and risks are communicated to management and QA teams as aligned with QA Audit Planner and Risk Management. Ability to conduct activities without supervision and applies systemic approach and strategy to address any organizational risks identified through audits.
Responsibilities:
Audit Program: Performs and manages various types of audits in the audit program across GxP as assigned and/or identified under the direction of Head of QA GxP Audits. Generates and updates audit program documentation for assigned projects, conducts audit related activities from preparation to writing and distribution of reports. Collaborates with Consultant Auditors to ensure the performance of audit activities and assists in the review of Consultant Audit Reports. Ensures on-time issuance of audit reports and effective collaboration with stakeholders and QA cross-functional teams (QA RD, DSJ QA, DSE QA, QA Standards and Procedures as well as QA IMP teams as applicable)

Corrective and Preventative Action (CAPA Plans), and CAPA Effectiveness check: In close collaboration with CAPA and Deviation Manager, verifies, assesses, the adequation and resolution of CAPAs stemming from audits and inspections. Ensure adequate closure of CAPAs and QA R&D team are informed of outstanding CAPAs or CAPAs with critical impact on programs of critical importance. Ensure CAPAs and or trends included in respective QQRs are correct, adequate and provides the correct management awareness.

Regulatory Inspections: May lead, manage and or support regulatory inspections in collaboration with cross functional teams. Ensure that regulatory inspections at CROs impacting DSI/ DS groups within the Americas are duly communicated, tracked and outcome trended for continuous improvements. In collaboration with CAPA metrics and trending, ensure trends and CAPAs stemming from inspections are communicated appropriately within QA and at project team level. May perform other regulatory inspection duties as assigned by line manager.

Quality Management/Continuous improvement: Ensure lessons learned from audits are duly communicated, training prepared and that the organization is in perpetual state of compliance. Ensure appropriate interpretation of the regulations to key processes and may be tasked to improve and or enhance key quality procedures. May author such procedures as deemed necessary.

Cross-Functional and Global Team Participation: Collaborates with global QA teams in developing and implementing the global audit strategy. Ensures full understanding of business objectives and key priorities to adequately allocate and address audit needs together with QA Audit Planner and Risk Management. May participate in QA R&D functional meetings to provide audit targets, audit information and/or present on any at-risk programs resulting from audit outcomes. Ensure adequate liaison with QA IMP relevant to clinical materials and/or escalations of issues identified during audits that could impact supplies and/or require further GMP investigation.

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

Education/Experience:
Bachelor's Degree in Scientific, Health Care or Related Discipline
Master's Degree in Scientific, Health Care or Related Discipline (MA, MPH, MHA)
Background in Medical Health Profession (RN, Medical Technologist, etc.)
4 or More Years Pharmaceutical Experience
1 or More Years Experience in the GxP Environment

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.