Manager, QA GMP Process Excellence

Location
Bernards, NJ
Posted
Jan 04, 2022
Ref
R237
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

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.

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. Summary GMP QA Process Excellence Manager is accountable to identify, collect information and analyze quality related process to articulate the improvement of the process and its change being responsible to facilitate or lead that change internally and across the organization. The incumbent is responsible to develop methodologies for the tools which should be applicable to monitor the key and critical elements of a Quality Management System and to verify the effectiveness of the developed methods through the enhancement and application of improvement models of a lean process (PDCA, Six Sigma, Failure Modes and other Quality tools) supporting the maturation of the process and the performance of metrics aiming to reduce process risk and increase internal and external customer satisfaction.

This position has a strategic responsibility to support the maturity of GMP organization working closely with local, regional and global stakeholders across the Quality Assurance organization and also with members from different business functions such as Pharmaceutical Technology, Supply Chain and Regulatory Affairs to accurately evaluate, manage and retain all data information related with products, compounds, suppliers, QA regulatory records, manufacturing and quality process, and requirements in order to support ensuring the full potential of the organization. Responsibilities
  • Accountable to design, develop and improve quality processes:
    • Analyze the current QA GMP practices/procedures
    • Collect business/regulatory requirements from quality and stakeholders
    • Identify and propose changes to the processes aiming the maturity of compliance level
    • Elaborate and review quality procedures supporting also the author to draft local or global procedures, standards or instructions
    • Identify, establish and monitor key performance indicators for several quality process to ensure performance monitoring
    • Develop, implement and monitor the efficacy of training program for quality procedures
  • Monitor and evaluate quality process performance for continuous improvement aiming the reduction and mitigation of process risk and increasing process maturity and customer satisfaction
  • Design and propose global IT system strategy. Identify and implement IT solutions that support the quality processes and management activities. Support the usability and readiness of implemented systems. Propose and assist the change management process for electronic systems.
  • Develop tools, deliverable formats and methodologies for process improvement, management of compliance requirements and effectiveness check review to ensure the local and global adherence to the processes defined.
  • Support the management of Global Standard/SOP/SOI in GMP area in corporation with Global QA document office.
  • Support the development of a global Quality Process Excellence team closely working with other regional functions to ensure consistency in methodology and deliverables, and to accumulate organizational knowledge.
  • Gather information on current and best practices in the pharma industry/companies, emerging solutions that could be applicable for quality management
  • Ensure the application and interpretation of continuous improvement models based on Quality tools such as PDCA, lean practices, Six Sigma and statistical approach
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 Scientific Discipline is required and
  • Master's Degree is preferred
Experience Qualifications
  • 4 or More Years In pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance, and audit is required and
  • Solid understanding of quality management and continuous process improvement principles including global cGMP requirements is required and
  • Direct experience dealing with multinational drug regulators, previous management experience and experience with various pharmaceutical dosage forms is preferred
TravelAbility to travel up to 10% 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.

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.