Quality Control Manager

2 weeks ago

Brisbane, United States Planet Pharma Full time

Quality Control Manager needed


Summary:

The successful candidate will have a good understanding of cGMPs, ICH stability, and regulatory drug requirements, be a self-starter with the ability to work under limited supervision and have the desire to be part of an innovative team. This is a unique opportunity to join a biotech company focused on developing life transforming therapeutics for patients with rare diseases. This position will be instrumental in supporting the company’s therapeutic products from early-discovery development stage to commercial launch and be a critical part of innovation team for the development of the company’s next generation products. The individual in this role is expected to carry out all quality control activities in a strict regulated environment (ICH/Compendial/FDA and EMA).


Responsibilities including, but not limited to:

Main focus: The Manager/Senior Manager of CMC QC will work across all products/programs as assigned (Clinical & Commercial products at West coast US) for quality control operational support

External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing needs.

  • Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, and release of Biologics, small molecule, and oligonucleotide products.
  • Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
  • Method Development and Validation: Support the development and validation of analytical methods used for QC testing of small molecule and oligonucleotide products.
  • Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.
  • QC data review: Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports.
  • Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines.


Other responsibilities may include:

  • Work within QC and with QA and other departments to address review comments on QC/analytical documents.
  • Manage/assist the document creations and reviews via Veeva Document System.
  • Create and update batch analysis tables for stability data.
  • Keep track of contract lab stability time point pulls for different programs.
  • Create Excel/JMP tables and graphs for stability data trending.
  • Initiate and manage change controls, deviations and CAPA in Veeva Document System.
  • Assist in OOE/OOS/OOT investigations and deviations.
  • Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support release and stability testing.


Requirements:

  • Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field.
  • Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries).
  • Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries).
  • Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirable.
  • Experience in conducting stability studies per ICH Guidelines is highly desirable.
  • Good oral and written communication skills and a fast learner.
  • 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).

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