- Expiry Date: 14 October 2021
Seeking an Specialist within the Global Product Quality, Cell Therapy Development and Operations (CTDO) organization. The ideal candidate will be an experienced Quality professional with prior experience working in a clinical and commercial QC setting. In this role, you will work closely with the QC Network Lead supporting harmonization efforts of platforms, strategies, technologies, global policies and procedures across numerous clinical and commercial sites in Washington, New Jersey, and other future sites within the cell therapy network. The ideal candidate will help drive efficiencies, improvements, risk mitigations, and alignment on common practices and strategies in support of routine GMP release and stability testing activities.
The candidate will support initiatives to implement new technologies developed for process and analytical improvements (including platform strategies, automation improvements, etc.) and help to improve the maturity of the Quality QC Network (practices, procedures, technologies, etc.) and programs owned by Global Product Quality within the CTDO organization.
The position will be responsible for ensuring compliance with current and prospective global regulatory requirements and should be aware of and adopt effective and efficient industry standard practices.
DUTIES and RESPONSIBILITIES:
Collaborates within individual site QC teams, Global Product Quality, and individual functions (i.e. analytical development) to support strategies for improvement and implementation of best practices and automation.
Assists with the continuous improvement of global QC Operations pertaining to quality oversight of QC testing laboratories and helps ensure quality related items are tracked, monitored and resolved in a timely manner.
Performs document management responsibilities in support of global QC network as needed. May own policies and procedures as needed across global QC network.
Develops, monitors and reports on Network QC activities, establishes Key Performance Indicators, and creation of dashboards and provides updates to management/leadership teams.
Identifies global QC network issues and effectively and proactively communicates and resolves them in a diplomatic, flexible, and constructive manner.
Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (FDA, EMA, PMDA, etc.) requirements for cell-therapy programs.
Must be a change agent to drive harmonization across multiple QC sites / organizations to align on a common strategy to improve efficiency, align on technology platforms and reporting metrics, and establish best practices to roll out across the global QC network.
Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision. Experience with automation and implementation across multiple sites is also desired.
Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
Strong technical writing skills.
Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.
Must be able to effectively streamline operations, design workflows, and establish performance measurement systems.
Must have knowledge of lean concepts and process
Strong communication and presentation skills
Strong ability to influence
Ability to think and drive strategic initiatives across a large span of operations
Strong project management skills and ability to communicate effectively across matrix functions
EDUCATION and EXPERIENCE
Bachelors and/or Masters degree in scientific discipline with a technical understanding of biopharmaceutical production and understanding of cell therapy and drug product development and manufacturing
Minimum of 4-7 years of biologics industry experience in a technical role(s) supporting programs in pre-clinical phases through commercial, with at least one or more role (4+ years) in Quality (QA, QC and/or Compliance)
Strong knowledge of global regulations (EU, US) and GxP experience
Excellent verbal and written communication skills
Ability to prioritize and balance work from multiple projects in parallel
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