Associate Director, Regulatory Quality Management & Compliance in Bernards, NJ at DSI

Date Posted: 8/12/2017

Job Snapshot

Job Description

IMPORTANT NOTE: We are very pleased to announce the location of Daiichi Sankyo, Inc.’s new US headquarters where our Parsippany- and Edison-based teams will be co-located in a combined site in early to mid-2017. Our new headquarters will be in Basking Ridge, New Jersey at 211 Mt. Airy Road.

Job Summary

Establish and maintain a quality management system in regulatory affairs. Provide guidance and strategy to regulatory staff to ensure regulatory deliveries are of constant high quality and are in compliance with regulatory requirements. Represent West RA in internal and external interactions (e.g. project teams, working teams, authorities, affiliates, partners).

Responsibilities

1. Internal processes:
  • Identify and evaluate internal West RA processes, whether these are timely, efficient, consistent, have clear roles, responsibilities and interfaces, and result in regulatory deliveries of constant high quality. Take into account regional differences and requirements, identify and assess risks on regulatory compliance.
  • Identify whether processes need to be established as SOPs, AOPs or best practice guides/ manuals and whether there is need for training of staff.
  • Identify and assess whether standards or templates to support processes are needed and support their development.
2. SOP development and maintenance:
  • Act as functional representative of West RA in the West SOP Committee and the office member of the GRA SOP committee.
  • Support the identification, development and maintenance of Global and local SOPs.
  • Develop training material for LMS on request by QA.
3. Education and training:
  • Monitor the regulatory environment for relevant changes in laws, regulations and procedures and identify training and education needs for West RA staff.
  • Maintain the West RA training curricula for staff at Basking Ridge and Munich sites, facilitate or support class-room and/or WebEx procedures if not done by other subject matter experts. Act as primary contact for West RA staff regarding questions on procedural documents (including templates and authoring) under the umbrella of West SOP and GRD SOP Committee.
  • Develop and maintain on-boarding training manuals for new RA staff, RA staff becoming involved in new activities and external staff.
4. Regulatory compliance and supervision:
  • Be the primary contact for Quality Assurance Operations (DSI) and QA GCP/GVP/RA (DSE).
  • In collaboration with QM/QA GMP and RA-CMC ensure adequate processes are in place and are followed for quality related changes applicable marketed products in DSI and DSE territories.
  • In collaboration with the labeling team and pharmacovigilance, ensure that processes are in place and followed to implement and track implementation of core safety changes in line with national requirements for products marketed in DSI and DSE territories.
  • In collaboration with RO and IT-QM/QA support the validation of systems and databases.
  • Plan and execute self-inspections and audits as well as writing and follow-up of the CAPA report in collaboration with QA.
  • Support the bidding process for external vendors and perform audits if necessary.
  • Support health authority inspections.
  • Provide guidance to West RA regarding SOP deviations.
Qualifications

Education
  • Pharmacy degree is preferred; Bachelor degree in Life Science or Medical Science; PhD or Master Degree is a plus.
Experience
  • 7 + years experience in the pharmaceutical industry and a minimum of 3 years working in a Quality management or Quality Assurance position. Additional experience in Regulatory Affairs is preferred.
  • Working knowledge of laws, regulations and guidelines is essential. Experience of working in a global, international environment.
  • Understanding of drug development and regulatory processes. Ability to interact effectively with FDA and other supervising authorities.
Competencies
  • Excellent interpersonal skills; ability to work across functions in a multinational organization to accomplish results. Be “detailed-oriented”; well organized and self-motivated; high ethical behavior, excellent written and oral communication skills in English, second language (e. g. French, Spanish, Portuguese, German, Japanese) is a plus.
  • Computer proficiency (e.g. MS office).
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.