Sr. Quality Operations Specialist, Gene Therapy (v549)

  • Contract Duration: 12+ months, Onsite
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Job description

Lenox Executive Search is seeking a candidate for a contract role for a Sr. Quality Operations Specialist, with one of our global pharmaceutical clients. This is a one year contract position with the possibility of extension/conversion.

Key Knowledge/ Skills and Competencies of a Sr. Quality Operations Specialist:

  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Collaboration / Teamwork
  • Ability to independently lead cross-functional teams and represent the Quality unit
  • Communication
  • Ability to communicate effectively across all organizational levels
  • Critical Thinking / Problem Solving
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Attention to detail
  • Expert knowledge of GMP requirements governing oral drug products manufacturing practices
  • Proven experience supporting GMP manufacturing either via experience in manufacturing and /or experience providing QA operational support of GMP manufacturing

KEY RESPONSIBILITIES of a Sr. Quality Operations Specialist:

  • As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Company Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
  • Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, packaging and label operations
  • Responsible for batch disposition activities. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
  • Responsible for review and approval of COAs, and product release
  • Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
  • Review and approval of manufacturing documents.
  • Develop and deliver technical training programs
  • Supports drafting and revising Quality Agreements between CMOs/Suppliers and Company, as needed
  • Provide QA support of change controls, GMP investigations and CAPAs. OOS and OOT investigations and ensuring appropriate CAP actions are identified.
  • Provides experienced technical advice for fill finish related program decisions
  • Provides project support involving technical transfers, engineering projects and similar activities
  • Participate in compliance walkthroughs and help drive the closure of any observations
  • Responsible for identifying risks and communicating gaps for GMP process/systems
  • Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
  • Participate in continuous improvements of department processes.
  • Participate in inspection readiness and support activities
  • Participate in process improvement initiatives (as necessary).
  • Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner
  • Experience on product complaints investigations and recalls

REQUIRED EDUCATION AND EXPERIENCE of a Sr. Quality Operations Specialist:

  • Demonstrated success by independently leading cross-functional teams
  • Experience providing QA support and oversight of GMP manufacturing operation including batch release
  • Experience with ATMP drug product development and manufacturing with proficient knowledge of the following in a pharmaceutical setting
  • Cell and gene therapy cGMP’s and associated CMC regulatory considerations
  • Aseptic processing
  • Experience successfully leading event investigations, Root Cause Analysis and CAPA
  • Experience with network-based applications such as Oracle, TrackWise
  • Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 3-5 years of relevant work experience, or relevant comparable background.

Job Type: Contract

Salary: $50.00 – $65.00 per hour


  • Monday to Friday


  • Bachelor’s (Required)


  • batch release: 1 year (Preferred)
  • package label: 3 years (Preferred)
  • change control: 3 years (Preferred)
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