Quality Assurance Manager

2 days ago

Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Details

Join a Legacy of Innovation

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 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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.

Summary

Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible to ensure efficiency, accuracy and standardization in high commitment level for document management and data integrity. The incumbent is responsible for authoring, review and manage the development of internal procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and to manages a Quality Assurance Agreement system which provides a realistic and accurate information to oversee and support vendor qualification program and the relationship with contract organizations. Collect, conduct and evaluate data for critical operations related with Annual Product Reviews. Manages the completion of stability studies program of drug products marketed in US and exported from US.

Responsibilities

- Quality Assurance Agreements: Manages a comprehensive system for the establishment of local and global Quality Assurance Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply as per local and international regulations and guidelines satisfying DS requirements and supporting the company's vision. Ensure proactive planning and completion for QA Agreements establishment and review process in a timely manner as necessary.
- Change Control System: Manages an effective Change Control System able to capture and deal with changes proposed by manufacturers, customers, internal improvements and/or Health Authorities requirements. Responsible to communicate in timely-manner with several internal and external partners and functions in order to properly address all the proposed changes, ensuring the right QA assessment and looking for the best strategy to avoid any impact for commercial and investigational products availability in order to cover patient needs.
- CAPA Management: Ensure oversight for CAPA Management activities in order to define and follow the completion plan up. Responsible to communicate in timely-manner with several internal and external partners and functions in order to ensure the deadline of CAPA plan is followed on rigor as per defined in the internal procedures.
- Product Data Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal procedures and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario to ensure that products are following high quality standards to meet patient needs. Responsible to lead the activities related with stability studies program performance in accordance with internal procedures and regulatory requirements in connection with contract testing laboratories to ensure the compliance for products marketed and/or distributed locally. May author or review stability studies protocol or reports. Provide the support for management and update of technical registration documents
- Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance and reporting Quality Metrics in a periodical manner and communicate this to Senior Management handling Quality Meeting sessions, identifying potential quality issues and proposing suitable solutions fostering a preventive mindset across the team and to the organization based on the metrics collected.
- Development of Standards and Procedures (SOPs) and Training: Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. Responsible to adhere and implement key global/regional QA GMP Standards, Procedures and Instructions. Supporting SOP authoring and reviewing process among GMP functions. Responsible to provide enough training for the related GMP and non-GMP activities involved with QA System Management processes.
- Cross-Functional Team Participation: Collaborate with the functional representatives within DSI and globally within the DSG network to align processes and procedures as they pertain to how the organization executes work and ensure alignment with industry regulations and best practices. Partner with local and global functions to provide guidance and oversight of specific processes. As part of global support, ensure cross-functional alignment and overall applicability across regions to support process excellence and compliance.

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

Education Qualifications (from an accredited college or university)
  • Must have a Bachelor's Degree in scientific discipline required
  • Master's Degree or other advanced degree preferred
Experience Qualifications
  • 4+ years of pharmaceutical, biologicals an/or vaccines including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit or equivalent experience required
  • Must have proven experience working with various pharmaceutical dosage forms
  • Mus have demonstrated expertise in working directly with multinational drug regulators and with our DSI external partners
  • Must possess a solid understanding of quality management and continuous process improvement principles including global cGMP requirements
  • Previous management experience strongly preferred


Travel

Must have ability to travel up to 10% including overnight travel (international and domestic)

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.

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