Senior Manager, QA Lot Disposition

2 weeks ago

San Carlos, United States The Steely Group Full time $80 - $85
Job DescriptionJob Description

 

We are looking for a dynamic quality customer-focused professional with working experience on product lot release of internally and externally produced products including raw materials. This individual will have the ability to handle multiple priorities and meet CMC deliverables as one of the SMEs for product disposition.

Essential Responsibilities:
This individual will be responsible for supporting external supply chain cGMP operations and internal cGMP Operations as needed and will, at a minimum, include:

  • Perform Lot Release Disposition of Internally and Externally produced products.
  • Represent QA team leadership to respond to CMC deliverables on product disposition externally and in some cases, internally
  • Coordinate with External Quality Assurance to compile and review all documentation to perform Quality Release of Externally produced Products
  • Assist in the completion and maintenance of CMO/CTO Quality Agreements
  • Actively support the development, implementation, and maintenance of our quality management systems & applicable SOPs
  • Perform reviews of cGMP documentation, both in-house and at contract organizations.
  • Review and approve completed batch documentation for cGMP production, including QC documentation of release and in-process testing
  • Lead investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review.
  • Release raw materials and batches/lots for further manufacturing, clinical trials, and commercial distribution
  • Oversee and perform training of personnel to ensure compliance and conformance to our requirements
  • Develop, apply, revise, and maintain quality assurance protocols and methods for processing materials into partially finished or finished products
  • Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
  • Participation in the ERP and Quality System implementation, training, and maintenance activities
  • May ensure compliance to in-house and/or external specifications and standards, (i.e. GLP, GMP, ISO, Six Sigma)
  • This individual will be expected to effectively follow SOPs and policies, and cGMP compliance regulations.  Additionally, he/she should be able to independently manage review times to meet priorities and communicated timelines.
  • This individual may be asked to travel to support business operations that involve contract manufacturing.  Anticipated travel is approximately 5-10%.


Key Internal and External Collaborations and Interface:

  • Internal Collaborations – Manufacturing, Quality Control, Quality Operations, Process Development, Analytical Development, Supply Chain, Regulatory Affairs, Alliance Management, among others
  • External Collaborations – Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs), Partnered Program Companies


Qualifications:

  • 10+ years of industry experience with 8+ years experience in Quality Assurance/Quality Systems related experience in a cGMP pharma/biologics regulated manufacturing environment is required
  • Possess a working knowledge of 21 CFR FDA, EU and ICH guidelines
  • Bachelor’s degree or higher in a relevant scientific area is strongly preferred
  • Relevant Quality Systems experience including Supplier and CMO/CTO Management, Raw Material Review Board Team Management, Change Control, Documentation Control, Training and Raw Material/Final Product Release
  • Skilled in evaluating and implementing solutions for regulatory compliance guidelines
  • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
  • Knowledge and ability to sufficiently train others on regulatory compliance issues pertaining to external requirements
  • Strong interpersonal skills and ability to work with others in a positive “can do” and collaborative manner
  • Balanced decision making that demonstrates critical thinking
  • Able to establish priorities and maintain progress even under uncertain circumstances
  • Strong verbal and written communication skills are essential
  • Strong communication, prioritization and organizational skills
  • Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies
  • Ability to utilize multiple word-processing and database applications
Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

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