Director, QA System Management in Basking Ridge, New Jersey at DSI

Date Posted: 2/3/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:
Accountable to lead/oversee/direct team responsible for establishment & control of Quality Management System (QMS) as per applicable regulatory standards & company expectations ensuring that the quality management system drives global regulatory compliance, is scalable & appropriate for the organization & product portfolio. Ensure efficiency, accuracy & standardization in high commitment level for document management & data integrity. Support strategies among GMP teams to integrate the functions & maximize the performance of activities to drive the vision of organizational strategy for the local & global functions interacting with QA.

Directs & owns the development of internal procedures to ensure adherence to the implementation of global Quality Standards & regulatory requirements for GMP area. The implementation of such oversight model would ensure the level of QA system oversight necessary for Change Control, Deviation, APQR (Annual Product Quality Review) for GxP suppliers. Direct with DS manufacturing sites, functional/divisional business units, commercial units to evaluate/implement change control proposals through a strategic process ensuring adequate process is in place to evaluate impact of key quality product characteristics (including Safety, Integrity, Strength, Purity & Quality).

Responsible for creation, establishment & management of Quality Assurance Agreements system with contract organizations. Conduct data evaluation for critical operations identifying, triaging & escalating quality issues with recommendations to Sr Mgmt to establish preventive/corrective measures. Responsible for control, evaluation/implementation of change controls strategies for products & processes & to monitor the performance & efficiency for changes. Monitors procedures & defining verification procedures for all activities to ensure data management of drug products marketed in US & exported from US & acts as a global partner to successful drive QA GMP deliverables, included but not limited to Annual Product Reviews & Stability Studies performance. Ensure adequate monitoring of procedures & defining verification process to monitor all periodic activities to ensure Quality oversight.

Effectively drive the level of accountability & performance needed to accurately manage & retain all data information related with products, compounds, suppliers, QA regulatory records, etc. in order to achieve the full potential of the organization.

Responsibilities:

Quality Management System & Oversight: Implement a strategy & governance process for GMP QMS. Lead governance processes, monitor progress, & provide updates to Sr. Mgmt within activities to ensure the update of technical registration documents working cross-functionally with CMC, RA & PT functions.

Quality Metrics: Directs a comprehensive tracking & trending QMS metrics program including, but not limited to, those related to deviations, CAPA, Change Controls, OOS, & internal/external audits performance. Evaluation & review of Quality Metrics in a periodical manner & to communicate to Sr Mgmt, identifying potential issues & proposing solutions fostering a preventive mindset across the team & to the organization based on the metrics collected.

Cross-Functional Team Participation: Collaborate with functional representatives within DSI & globally within the DSG network to align processes/procedures as they pertain to how the organization executes work & ensure alignment with industry regulations/best practices. Partner with local/global functions to provide guidance & oversight of specific processes. Ensure cross-functional alignment & overall applicability across regions to support process excellence & compliance. Champion an environment of transparency & continuous improvement in managing & implementation of Quality Process & Procedures & to ensure the adherence to the Global Quality Manual. Support the activities involving new business partnerships from GMP QA perspective. Support & set a standardized process within GMP to avoid conflict of procedures/processes within the functions. Collaborate with other local, regional & global QA functions to ensure oversight & review process for CMO & customers procedures relevant to QA activities are adhered to.

Development of Standards & Procedures (SOPs): Liaise with GMP areas to ensure adequate procedural documents directly impacting area of responsible &/ or other GMP areas as assigned. Lead &/ or direct key global/regional QA GMP Standards, Procedures & Instructions reviewing or definition process to set the best recognized practices at high level pharma companies & fostering the future regulatory trends.

Management & Career Development for Personnel: Manage performance & ensure sustained performance through feedback of direct reports. Motivate, engage & encourage career growth & trajectory of direct reports by providing mentoring, coaching & advocating for continued learning both internal &/ or external. Attract & retain talent.

Budget Management: Prepare & adhere to annual budget to manage expense expectations & provide fiduciary oversight to the QA function.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Bachelor’s Degree in scientific discipline required. Master’s degree level preferred.
  • Minimum 7 yrs in pharmaceutical, biological &/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance & audit. Experience with various pharmaceutical dosage forms desired.
  • Experience leading world-class quality organization.
  • Direct experience dealing with multinational drug regulators & direct reports. Previous management experience.
  • Solid understanding of quality management & continuous process improvement principles including global cGMP requirements.

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.