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Manager, Quality Control Consultant

The Steely Group

Hybrid, Waltham, MA

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JOB DETAILS
SKILLS
Analysis Skills, Analytical Chemistry, Analytical Development, Biology, Business Model, Consulting, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Collection, Data Management, Data Quality, Disease, Document Control, Document Management, Dosage Forms, Drug Development, Drug Products, Drug Release, Fourier-Transform Infrared Spectroscopy (FTIR), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), Laboratory Analysis, Laboratory Information Management System (LIMS), Laboratory Management, Oncology, Operational Support, Oral Administration Drugs, Organizational Skills, Outsourcing, Pharmaceutical Analysis, Process Development, Process Improvement, Product Development, Product Packaging, Product Reviews, Product Support, Product Testing, Product/Service Launch, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Submissions, Small Company, Small Molecule Drugs, Small Molecules, Spectroscopy, Support Documentation, Team Player, Technical Writing, Test Data, Testing, Time Management, Traceability
LOCATION
Hybrid, Waltham, MA
POSTED
2 days ago
The Manager, Quality Control Consultant is a hands-on support role responsible for executing and coordinating cGMP quality control activities associated with development and commercialization of the company’s small-molecule assets.

This function operates within a hybrid work environment with 100% outsourced analytical and QC testing. The incumbent will provide direct QC operational support for activities related to drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. This person will review protocols, methods, reports, batch records, and related GMP source documents; support stability operations and reference standard programs; and actively manage QC data and documents using systems such as Excel, Veeva LIMS, SmartSheet, JMP, and Veeva for clinical and commercial projects.

The selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

This role is expected to begin as a strong execution and support position, with the opportunity to progressively take on greater ownership and lead QC projects as experience and business needs evolve.

Key Responsibilities:
QC Operations and Project Support 65%
  • Directly support project leads with QC operational activities across development and commercial programs, with emphasis on executional support in the near term and the potential to assume increasing ownership of discrete QC projects over time.
  • Perform detailed QC review of analytical test data for regulatory starting materials, in-process testing, drug substance and drug product batch release, and stability studies.
  • Support release and stability workflows through data review, data transcription, data verification, and compilation of results in internal tracking tools and reports.
  • Maintain QC document management activities, including organizing, tracking, and reconciling protocols, reports, specifications, worksheets, certificates, and related GMP records in systems such as Veeva, and Veeva LIMS.
  • Support Annual Product Quality Review (APQR) preparation and review by compiling trend data, verifying source data, and contributing to quality metrics summaries.
  • Perform routine internal QC activities such as data trending, status tracking, reference standard and reagent inventory support, and follow-up of action items to enable timely batch disposition and stability reporting.
Analytical and Lifecycle Support 25%
  • Support analytical method lifecycle activities by coordinating documentation, reviewing supporting data packages, and assisting with method transfer, qualification, validation, and implementation records.
  • Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities.
Systems, Tools, and Continuous Improvement 10%
  • Use and help maintain digital tools and trackers (e.g., SmartSheet Veeva LIMS, Veeva, JMP, and related QC systems) to support data review, document control, trending, and operational visibility.
  • Identify process improvement opportunities to strengthen internal QC workflows, improve data accuracy, and enhance efficiency in a virtual quality control operating model.
Other duties and responsibilities as assigned

Required Qualifications:
  • B.S. degree (with at least 6 years of experience) or an M.S. degree (with at least 4 years of experience) in analytical chemistry or related life sciences discipline. Work experience should include a combination of data management and quality control experience in pharmaceutical product development and/or commercialization.
  • Hands-on experience and/or familiarity with HPLC/UPLC, GC, KF, spectroscopy (UV, FTIR, etc.), dissolution and other common analytical techniques used for small molecule drug substance and solid oral dosage drug product testing.
  • Advanced working knowledge of cGMP compliance requirements for pharmaceutical analytical development and quality control laboratories.
  • Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
  • Ability to work independently with good judgement and strong organization skill

Preferred Capabilities:
  • CDMO management employing cross-functional collaboration skills.
  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is desirable.
  • Small molecule pharmaceutical development for solid oral dosage forms.
  • Experience in a hybrid or virtual  biopharmaceutical development business model with 100% outsourcing of analytical and QC testing is preferred.

About the Company

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The Steely Group

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