Manager, GMA Quality Assurance

Location
Basking Ridge, New Jersey, United States
Posted
Sep 15, 2020
Ref
10477BR
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.

Job Summary:

Support the quality strategy closely aligned with the Oncology Global Medical Affairs business strategy within the US; promote a quality culture within GMA by providing study team support to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards across the United States.

Support end to end proactive quality support across programs ensuring GCP, GPV, GDP, and adherence to safety requirements are adequately considered for all GMA programs.

Proactively collaborate with other GxP quality representatives and act as US QA point person for GMA/Regional programs, e.g. interact with for prompt identification and resolution of issues; timely escalation of incidents/issues; oversight for deviations/incidents & investigations, 3rd party/vendor oversight and liaison to support audit and inspections as applicable.

Support local GMA and GPV inspections with adequate systems and process support.

Ensure timely and effective preparation of regulatory submissions and HA inspections, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with business functions for the US.

Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including timely escalation of critical issues, tracking of timely closure, and proper effectiveness checks.

Support lessons learned information flow based on read outs from audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics.

Support continuous process improvement, interpretation of regulations, quality and compliance with regulations and company standards, policies and procedures through partnership with stakeholders and QA line functions.

Support the annual Quality Plan for GMA and the tracking of Key Quality Indicators (KQI) for GMA (e.g. Quality Plan status, metrics, trends in deviations and inspection/audit findings, inspection/audit CAPAs).

Responsibilities:

Leadership/ Program oversight: Support the quality strategy and/or quality plan closely aligned with the Oncology Global Medical Affairs business strategy within the US; promote a quality culture within GMA by providing study team support to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards across the United States.

Support end to end proactive quality support across programs ensuring GCP, GPV, GDP and other local requirements are adequately considered in the planning and conduct of Interventional, Non-interventional, Managed Access Programs and Investigator initiated studies.

Support adherence to regulatory safety requirements for all programs (i.e. post marketing, MAA requirements, phase 3b SAE reporting, SUSAR distribution).

Support the importance of GMA programs as essential to promote the value of marketed products and ensure ongoing compliance of GMA studies to Health Authority requirements and expectations to support label extension, ongoing submissions as well as managed access programs which allow access to unapproved medicines for patients with unmet medical needs.

Quality Management and Continuous Improvement:
Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including tracking of timely closure, proper effective checks and adequate and timely escalation of critical issues.

Support lessons learned information flow based on read outs from audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics.

Cross-functional and Global Team Participation:
Proactively collaborate with other GxP quality representatives and act as the US point person for GMA/Regional programs, e.g. interact with subject matter experts for prompt identification and resolution of issues across the four pillars of GMA activities: Interventional studies, Non-interventional studies, Compassionate Use or Managed Access Programs and Investigator initiated studies to include timely escalation of incidents/issues; oversight for deviations/incidents & investigations, 3rd party/vendor oversight and liaison to support audit and inspection as applicable.

Customer Focused/ stakeholder engagement:
Support interpretation of regulations and company process standards, guidelines, policies and procedures to personnel specifically for assigned programs or for continuous improvement projects.

Provide guidance to teams during the development and execution of Corrective and Preventive Actions (CAPAs) including liaising with functional representatives to ensure timely closure of CAPAs, proper effective checks and adequate and timely escalation of critical issues.

Regulatory Inspections:
Ensure timely and effective preparation and management of regulatory submissions and HA inspections, including facilitation of respective regulatory inspection preparation and management and follow-up in collaboration with relevant business functions for the US.

Support local inspections with adequate systems and process support.

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

Education/Experience:
  • Required B.S. Degree in Life Sciences, Pharmacy or Medicines. Advanced degree Preferred.
  • Eight (8) plus years of pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in regulated GCP environment. Additional experience in Clinical Safety and Pharmacovigilance desired. Medical Affairs Experiences helpful.
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.
Job Title
Manager, GMA Quality Assurance

City
Basking Ridge

Functional Area
Quality Assurance

State
New Jersey