Associate Director, External Supplier QA-GMP

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary

Accountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates and Headquarter to support with routine and unusual issues related with Global Products.
Responsibilities

• Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
• Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small-molecules products manufactured at CMO’s and ensures the validation requirements for all global markets are also met.
• Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations.
• Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and instructions that affects and directs CMO activities. This position can be supportive also to oversight and QA support for product and process technology for acquired or transferred product into and out of CMO’s organizations.
• Deviation and Complaint Investigation Program: Provides support to the investigation of deviations and complaints in order to ensure a timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates.

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 in scientific discipline required or
• Master's Degree or other advanced degree preferred

Experience Qualifications

• 7 or more years in biological or pharmaceutical operations including required along with first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.
• Experience with biological manufacturing and technical transfer required along with experience dealing with contract manufacturing organizations.
• Must have proven experience dealing with multinational drug regulators.
• Demonstrated understanding of quality management and continuous process improvement principles including global cGMP requirements.
• Expertise in Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is strong preferred.
• Previous management experience preferred
   

Travel

Must have the ability to travel up to 30% domestic and international

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.