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Senior Manager, Quality Operations

Cellares

Cellares

Operations, Quality Assurance
Bridgewater, NJ, USA
Posted on Thursday, May 9, 2024
We are seeking an innovative and highly motivated Senior Manager, Quality Operations, who will contribute significantly to the growth of the Cellares team.
This individual will be responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. This individual will develop, implement and execute long-term Quality programs. This individual will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team and processes. This individual will also manages a team within the QA department based on assigned work, direction, coaching and developing capabilities
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

  • Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements
  • Act as the IDMO Site SME for Quality Operations functions during client and Health Authority inspections
  • Partner with other functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
  • Responsible for all aspects of incoming and final product disposition for the site
  • Responsible for batch record review activities for the site and coordinating Drug Product Release with clients
  • Oversee quality shop floor program to ensure compliance of the manufacturing operations
  • Responsible for providing quality oversight of the QC laboratory
  • Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
  • Manage team professionals within Quality
  • Hire and develop employees within the department
  • Coordinate quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes
  • Establish effective partnerships with clients, business units, sites, and individuals to ensure business processes are effectively linked.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
  • Other duties will be assigned, as necessary

Requirements

  • Bachelor’s degree in a scientific or engineering discipline
  • 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
  • 5+ years of leadership experience, and demonstrated knowledge of relevant cGMP regulations
  • Excellent knowledge of the regulations for biologics, cell and gene therapy products
  • Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is required
  • Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
  • Hands-on experience with designing and implementing GMP Quality Systems
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
  • Demonstrated experience in preparing regulatory submissions and response to health authorities queries
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.