Senior Director, Strategic GMP QA Ops

Location
Basking Ridge, NJ
Posted
May 20, 2022
Ref
R753
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

Accountable to lead, oversee and direct strategic projects across GMP QA organization aiming the implementation of organizational strategy related to cultural changes initiative, supporting the commitment with DS vision and carry-on projects level oversight and end to end risk-based deployment in relation to GMP QA activities.

The incumbent is responsible for providing QA leadership whenever necessary and/or with the direction of high echelon which includes Global QA Head and local high management. Proactively direct an innovative quality oversight in partnership with another GxP functions enabling key business partners to develop and deliver strategic solutions more rapidly and effectively. Establish and / or develop operational resource strategy to successfully deliver strategic business change and comply with GMP QA objectives.

This position has a global and regional responsibility in order to effectively drive and elevate the level of compliance and performance needed to achieve the full potential of the organization to deliver products of high quality to patients with unmet medical needs.

This position has direct reports. The incumbent will be responsible for management and career development for their direct reports.

Responsibilities

  • Strategic Projects and Initiatives: Design, structure and lead local, regional or global QA GMP projects that drives the organization into the deliverables to achieve short- and long-term strategies for high level compliance level. Develop integrated quality frameworks using planning and risk assessment capabilities. Responsible to engage people and building capabilities required for excellence operational at several levels of organization working cross-functionality aiming products and processes improvement, efficiency, and creation of a sustainable business strategy. Proactively identify regulatory compliance risks to align with internal and external regulatory guidelines and standards. Ensure proactive planning and forecasting for relevant QA GMP activities and QA review process as necessary. Ensure QA teams are fit for purpose to deliver against projected milestones.
  • QA GMP Strategies: Use quality analytics data and contextualize key quality insights to primary partners and provide quality consultancy. Cascade and disseminate operational strategies necessary for implementation within respective QA GMP functions. Support decision making process and effectively communicate with local, regional and global Heads ensuring a proactive collaboration platform. Engages in strategies deployment and implementation plans for QA GMP operations and exercise abilities to be proactive and anticipate the needs for group management through an efficient communication process. Support transformation of QA GMP through quality maturity modeling by development of cross-functional and cross-segment planning across the enterprise.
  • Cross-Functional Team Participation: Leads and directs QA GMP organization participation in local, regional and global project teams, including managing the assignment of GMP QA members to various working groups and providing direction and consultation, also, is responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates. Proactively supports:
    • Global QA GMP CMO Management supply approach across the organization.
    • Strategy and activities related to the launch of new products;
    • Strategy and activities related to the support and development of new clinical trials specific to investigational products;
    • Liaise with another internal GMP or GxP / RD functions and affiliates to ensure adequate involvement for strategic deliverables across QA organization.
      Support the activities involving new business partnerships from GMP QA perspective in all aspects of an integrated (includes identification, risk assessment and execution, business partnering and coordination) external opportunities quality support model for licensing, acquisitions, divestitures, and emerging business models, etc.
  • Global Staff: Acts as global staff representing DS affiliates and business in Americas region driving the implementation of global QA Manual across the region and monitoring the compliance of relevant process in order to ensure consistency among affiliates for implement Quality Management System. Collects and analyzes relevant metrics for each site and compiles regional Quality report.
  • Partnership: Build unified partnership with QA group to provide one voice for quality risk assessment, remediation, and business partner support. Support the development of a model for real-time identification and management of quality issues while ensuring accurate ownership of remediation. Influence the leadership in the development of a diverse team with deep business and product knowledge to advise portfolio leadership and teams to mitigation and remediation strategies and contribute on inspection support teams during Health Authority inspections.
  • Communication: May represent leadership in meetings to communicate, deliver and/or execute the vision and strategy of QA GMP organization. Communicate clearly and in a timely manner with Global QA GMP organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA GMP mission across boundaries and with different stakeholders.
  • Budget Management: Prepare and adhere to annual budget to manage expense expectations and provide fiduciary oversight to the QA GMP function.


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 is required required and
  • Master's Degree preferred

Experience Qualifications

  • 10 or More Years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit. required and
  • Experience leading world-class quality organization.

    Direct experience dealing with multinational drug regulators and direct reports.

    Previous management experience.

    Solid understanding of quality management and continuous process improvement principles including global cGMP requirements.

    Demonstrated ability leading and delivering on strategies.
    required and
  • Experience with various pharmaceutical dosage forms. preferred

Travel

Ability to travel up to 20%


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.