Manager, Global Strategy and Operations (Global R&D PV QA) - Daiichi Sankyo Inc.
Basking Ridge, NJ
About the Job
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 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
Position is responsible for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are expected to understand and apply knowledge of the complexity of the Global organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned tasks. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills in database and research tools.
Responsibilities
Support the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA and Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Head Global QA strategy and operations (RDPVMA QA).
Supports the Head Global QA Strategy and Operations for Global RD/PV QA relevant activities including Business Plan, QQR, team building and management review.
Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutes
Involve and attend the QA strategic meeting and create the draft of presentation, meeting agenda and meeting minutes.
May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc.
- Support Operational activities:
- Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate
- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce accurate and timely reports as needed pertaining to Global QA activities
- In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date
- Support regulatory inspection related activities as required such as organizing CAPA coordination teams, ensuring logistics for inspections, ensuring team list for QA pertinent to inspections are maintained including, training, CVs, JDs
- Collect, store and maintain all auditable documentation as per DSI Internal control
- Support the Head Global QA strategy and operations to develop and plan the Global QA communication strategies and manage the communication activities;
- Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness.
- Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences
- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails)
- Create the QA Newsletter with Team
- Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (reorganization, talent profile, Financial Budget)
- Ensure ordering of office material and other relevant equipment
- Manage Calendar for Global RD PV QA of Leadership and ensure an organized approach
- Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient access to the system and information to do that work.
- Review the QA onboarding business slides edits and updates as needed
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)
- Bachelor's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession is required.
Experience Qualifications
- 4 + years of professional pharmaceutical experience in project management and operational support role and relevant additional career training preferred
- Must have broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.
- Training and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management systems.
- Strong interpersonal, communication, negotiation and problem-solving skills.
- Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams.
- In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)
Physical Requirements : Shipping out large packages/boxes. Moving/arranging file folders in large quantities. 5% of Time.
Travel
Ability to travel up to 5%
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
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
Position is responsible for supports of strategic leadership to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members as well as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are expected to understand and apply knowledge of the complexity of the Global organization. This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned tasks. Additionally, this position is responsible for upholding a strong commitment to confidentiality and routinely handles sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including word processing software and data management software, and business emailing software as well as intermediate skills in database and research tools.
Responsibilities
Support the Head Global QA strategy and operations (RDPVMA QA)on projects needing to be coordinated with both DSI QA and Global QA, ensure that teams are adequately engaged to deliver as expected and escalate any delays to Head of Group and / or Head Global QA strategy and operations (RDPVMA QA).
Supports the Head Global QA Strategy and Operations for Global RD/PV QA relevant activities including Business Plan, QQR, team building and management review.
Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutes
Involve and attend the QA strategic meeting and create the draft of presentation, meeting agenda and meeting minutes.
May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, Global QA meeting etc.
- Support Operational activities:
- Manage the QA shared point and ensure that information provided is accurate and reflects on going activities. Regularly check the site for accuracy, up to date information, and links as well as compile new content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate
- In collaboration with the Lead Global QA Strategy and Operations (RDPVMA QA), Collate and produce accurate and timely reports as needed pertaining to Global QA activities
- In collaboration with Executive admin, ensure QA org charts, team lists, projects assigned to individuals are current and up to date
- Support regulatory inspection related activities as required such as organizing CAPA coordination teams, ensuring logistics for inspections, ensuring team list for QA pertinent to inspections are maintained including, training, CVs, JDs
- Collect, store and maintain all auditable documentation as per DSI Internal control
- Support the Head Global QA strategy and operations to develop and plan the Global QA communication strategies and manage the communication activities;
- Distribute reports as necessary to the Global QA teams and ensure on time organization communication is cascaded to the teams for awareness.
- Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences
- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails)
- Create the QA Newsletter with Team
- Administrative support includes but not limited to: Responsible for travel, Financial Administration as needed (e.g. tracking of expenses for travel and office space), meeting arrangements for Head of Group and other associates as applicable. Handling of confidential documents (reorganization, talent profile, Financial Budget)
- Ensure ordering of office material and other relevant equipment
- Manage Calendar for Global RD PV QA of Leadership and ensure an organized approach
- Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient access to the system and information to do that work.
- Review the QA onboarding business slides edits and updates as needed
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)
- Bachelor's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession is required.
Experience Qualifications
- 4 + years of professional pharmaceutical experience in project management and operational support role and relevant additional career training preferred
- Must have broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.
- Training and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management systems.
- Strong interpersonal, communication, negotiation and problem-solving skills.
- Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally, Cross cultural and in global teams.
- In depth knowledge and working experience with common computer software programs, i.e. MS Office Suite (Word, Excel, Access, Outlook, PowerPoint, Visio, MS Project)
Physical Requirements : Shipping out large packages/boxes. Moving/arranging file folders in large quantities. 5% of Time.
Travel
Ability to travel up to 5%
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.
At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success. We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration. We provide employees with the training, tools and technology that they need to excel. Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee’s unique abilities are valued and utilized. We invite you to consider a career at Daiichi Sankyo, Inc.
Source : Daiichi Sankyo Inc.