Senior Manager CMC Quality Control Writer

2 weeks ago

Reston, Virginia, United States Tandym Group Full time
Job Title: Senior Manager CMC Quality Control Writer

We are seeking a highly motivated and experienced Quality Control Manager to join our team at Tandym Group as the Senior Manager for CMC Quality Control Department.

Responsibilities:
  • Oversee all aspects of QC data review for commercial and clinical programs, including modalities and molecules.
  • Collaborate with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure quality standards are met.
  • Work closely with cross-functional departments to achieve corporate goals and objectives.
  • Play a critical role in bringing therapeutic products from early-discovery development to commercial launch.
  • Be the analytical, technical, and quality operational subject matter expert for QC CMC writing, reviewing, and assisting in Regulatory filings.
  • Write, update, and revise CMC stability sections in support of regulatory filings.
  • Address CMC stability inquiries per regulatory inquiries.
  • Perform review and draft of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports, and other QC/analytical documents.
Other Responsibilities:
  • Participate in qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.
  • Generate QC documents, including CoAs, reference standard qualifications and reports, and risk assessments.
  • Work within QC and QA and other departments to address review comments on regulatory and QC/analytical documents.
  • Manage/assist document creations and reviews via Veeva Document System.
  • Create and update batch analysis tables for release data.
  • Create Excel/JMP tables and graphs/charts for release and stability data trending.
  • Initiate and manage change controls, deviations, and CAPA with Veeva Document System.
  • Assist in closing Quality Events/Deviations (OOS/OOT/OOE) and Deviation Investigations.
  • Ensure compliance with current GMPs in a manufacturing environment to support lot release and stability testing.
  • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.
Requirements:
  • Bachelor's degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences, or a related life science field.
  • Senior Quality Manager: 5+ years' experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries).
  • Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with tight deadlines.
  • Proficiency in MS Office, Word, and Excel.
  • Proficient in statistical analysis software desired (Excel/JMP).
Desired Skills:
  • Experience with writing and reviewing of CMC filings for regulatory submissions, including IND/IMPD, BLA, and/or MAA.
  • Good oral and written communication skills and a fast learner.
  • Working experience and knowledge in a wide variety of quality control release and stability methodologies.
  • A good understanding of cGMPs, ICH, and regulatory drug requirements, a self-starter with the ability to work under limited supervision, and a desire to be part of an innovative team.

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