- Support Head, Global strategy and operations 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 strategy and operations.
- Supports Head Global Strategy and Operations for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, 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 Global RD/PV/MA 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 Head, Global Strategy and Operations to track the objective and the midterm plan in Global QA to ensure Global QA activities globally.
- Support Head, Global Strategy and Operations to draft the Global RD/PV/MA QA strategy operation plan with Head, Global QA function to ensure Global QA activities globally.
- 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 Head, Global QA Strategy and Operations, 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
- Support Head, Global strategy and operations to develop and plan the Global QA governance, 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., emails)
- Create the weekly QA communication email
- 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)
- Manage Calendar for DSI QA Head and Head, Global Strategy and Operations 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
- Bachelor's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession required
- Master's Degree in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred
- PharmD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred
- PhD in scientific discipline or higher in, health care, or related discipline; and/or background in Medical Health Profession preferred
- 7+ years of professional pharmaceutical experience in project management and operational support role and relevant additional career training or equivalent experience required
- Must have broad understanding of Health Authority expectations in the areas of Pharma Development; preferably working in a GxP regulated environment, pharmaceutical industry.
- Proven knowledge of training and curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management systems.
- Must possess strong interpersonal, communication, negotiation and problemsolving skills.
- Organizational awareness (e.g. interrelationships of departments, business priorities), including experience working crossfunctionally, 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)
-
Legend Biotech Trenton, United StatesAssociate Manager, Commercial Strategy and Operations · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array ...
-
Head of Strategy, Operations, and Innovation
4 days ago
ADP Trenton, United StatesADP is hiring a Head of Strategy, Ops, and Innovation for our Data Solutions group. · The Head of Strategy, Ops, and Innovation will shape and propel the strategic initiatives that maximize the value generated from our data assets and AI capabilities for the betterment of ADP's c ...
-
Legend Biotech US Trenton, United StatesCompany Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
-
Legend Biotech Trenton, United StatesAssociate Manager, Commercial Strategy and Operations · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array ...
-
VP, Store Operations Strategy
2 days ago
Burlington Stores Burlington, United StatesPosition Summary:The Vice President of Store Operations Strategy & Analytics leads strategic operations, planning, analytics, and reporting for the Stores organization. The role is pivotal for evolving store capabilities to drive sales and operations execution across the 1,000+ r ...
-
VP, Store Operations Strategy
2 days ago
Burlington Burlington, United States**LOCATION** 1830 Route 130 North Burlington NJ US 08016 · **Overview** · **Position Summary:** · The **Vice President of Store Operations Strategy & Analytics** leads strategic operations, planning, analytics, and reporting for the Stores organization. The role is pivotal for ...
-
Bristol Myers Squibb New Brunswick, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Strategy and Operations Consultant
4 weeks ago
SEI Philadelphia, United StatesWHO WE LOOK FOR · An SEI-er is a master communicator and active listener who understands how to navigate an audience. Self-aware, almost to a fault, SEI-ers keenly understand how to adjust their support and problem solving based on the situation. Following a logical, fact-based ...
-
Bristol Myers Squibb Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Legend Biotech Somerset, United StatesCompany Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
-
Iovance Biotherapeutics, Inc. Philadelphia, United StatesIovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Specialist, Quality Control, Operations Strategy, who will support the long-term sustainability of the Lean Labs initiat ...
-
Bristol-Myers Squibb New Brunswick, United StatesExecutive Director Strategy amp Operations Lead · Employment Type · Full-Time · Industry · Clevel, Executive, Manager, Operations, 100k · Posted on · Apr 04, 2020 · Apply for this job · your email: · upload resume: · Profile · Bristol-Myers Squibb is a global Biopharma company ...
-
Genmab Princeton, United StatesAt Genmab, were committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, can ...
-
Iovance Biotherapeutics Inc Philadelphia, United StatesJob Description · Job DescriptionSalary: · Iovance is hosting an onsite Job Fair. · Where: Iovance Cell Therapy Center (iCTC) · Location: 300 Rouse Blvd Philadelphia, PA 19112 · Date: Monday, June 24, 2024 · Time: 12pm to 6pm (EDT) · What to bring: Updated resume · We are H ...
-
Bristol Myers Squibb Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Bristol-Myers Squibb New Brunswick, NJ, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Bristol Myers Squibb New Brunswick, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Chief Financial Officer
1 week ago
Credit Lender Trenton, United StatesThe ideal candidate will be responsible for financial strategy, financial planning and analysis, financial reports, treasury management, contract negotiation and more. They will collaborate with the CEO and the executive team to make decisions regarding company's financial strate ...
-
Portfolio Manager, North America
2 weeks ago
International Flavors and Fragrances Trenton, United StatesJob DescriptionIt's an exciting time to join IFF as our Portfolio Management Lead for North America. To be successful in this role, you understand how our customers see us and who we need to become. You know how to inspire and mobilize organizations against this vision. You have ...
-
Vice President Operations
6 days ago
DSJ Global Trenton, United StatesJob description · Head of Operations required for Cutting Edge Pharmaceutical Company · Manufacturing Operations Team · Trenton, NJ Area · $230,000-$265,000 + Bonus + LTIP · Relocation Assistance Provided · A cutting edge pharmaceutical firm is seeking a strong Head of Operation ...
Associate Director, Global Strategy and Operations - Trenton, United States - Daiichi Sankyo Company, Limited
Description
Associate Director, Global Strategy and Operations (Global R&D PV QA) page is loadedAssociate Director, Global Strategy and Operations (Global R&D PV QA)
Apply
remote type
Hybrid Work Arrangement
locations
Basking Ridge, NJ
time type
Full time
posted on
Posted 15 Days Ago
job requisition id
R2848
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.
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.
SummaryThis position is responsible to support strategic leadership of QA initiatives within QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations.
In this position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA, QA projects as assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA Training and Documentation management team.
This position will take direction from global strategy and operational QA leader, however is also accountable to the VP of quality.
The incumbent is expected to understand and apply rigor, focus and dedication with respect to the complexity of the Global organization.
This position has considerable latitude to make decisions without supervisor approval and solves problems while carrying out assigned duties.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.
The incumbent may be tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA, assess organizational transformation and its effectiveness and support large conferences and meetings.
The incumbent must have excellent communication, oral and written skills.The incumbent must have understanding of state of the art technology systems necessary to complete tasks and allow decision making.
ResponsibilitiesSupport Operational activities:
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)
Higher level of education preferred such as:
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.
About UsAt 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.#J-18808-Ljbffr