AbbVie

Biologics PQA - Global Change Control Manager

Employer
AbbVie
Location
PR, United States
Posted
Oct 28, 2020
Ref
2007368
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Biologics PQA Global Change Control (GCC) Manager establishes and maintains the Change Control process needed to ensure that Commercial Biologics products are manufactured following AbbVie's approved specifications and manufacturing instructions, in compliance with GMP and in line with regulatory submissions.
  • Responsible for the running of the Global Change Review Board (GCRB) process for commercial products in the Biologics region. Currently, this is for Humira and Skyrizi marketed products.
  • Provides Change Control oversight and expertise across all the manufacturing nodes for Biologics products in the market assuring comprehensive review and approval for all changes. Applies to bulk drug substance, drug product manufacturing and packaging sites (AbbVie and TPMS's), and Global/ PPT projects as applicable.
  • Sets and upholds the highest standards of change control to ensure a robust and systemic process is established and maintained and that all changes are adequately risk assessed and authored in a clear and logical manner. Acts as a gatekeeper to ensure all changes are Inspection ready.
  • Maintains formal contact with local Site and TPM CRBs and ensures changes with global impact are tabled at GCRB.
  • Acts as a link with other stakeholders proposing and executing changes not limited to S&T, IME, PSM, SCM, RA, R&D, and other QA functions.
  • Develops and implements continuous improvement for GCC business processes.
  • Leads Quality Risk Management and Knowledge Management activities for Commercial Products and the overall Bio PQA function.
  • Participate in CMC meetings for DS (drug substance) and DP (drug product). Support the regulatory filings and marketing authorization dossiers by developing and/or reviewing CMC documents and BLA documents.
  • Actively participates in change management and QRM COEs and policy discussions.
  • System owner of SolTraqs and Lot Smart for PQA Organization.
  • Supervisory Manager for GCC team.


Qualifications

• B.Sc. in Life Sciences or Engineering is essential.

• M.Sc. preferred

  • This position requires an experienced professional possessing broad Quality Management skills with an emphasis on a systems approach with strong compliance. Knowledge of GMP regulations and standards for Biologics products is essential. The role requires GMP experience in at least one of the following areas; Sterile products, SVP, BDS, Device manufacturing along with Quality Assurance or Regulatory Affairs experience in Biologics.
  • At least 8 years of combined experience in Quality, Manufacturing, or Technical Operations with at least 5 years related to Biologics products and processes. Understands the suite of interrelated documentation and systems underpinning product quality.
  • Possesses knowledge and skillsets required to operate within a global environment that requires a high degree of urgency, problem-solving skills, positive interpersonal skills, and the ability to manage multiple complex tasks and make decisions. Freely shares knowledge and develops change control competency for the team.
  • Ability to communicate and explain change control and to be a recognized SME on this critical aspect of the Quality System. Demonstrates the highest standards of verbal communication and written output.
  • Ability to devise and improve business processes.


Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.