Quality Manager

Location: San Diego, CA
Company: Primrose Bio
Salary range: $90,000 –$120,000 / year

Job Description

Primrose Bio, a biotechnology company enabling the development of innovative therapeutics, vaccines, and manufacturing tools, is seeking to fill a Quality Manager position.

The individual selected will oversee the development, implementation and maintenance of quality assurance systems and activities. The Quality Manager will function as manager of EDMS for the generation, review, approval, and archival of documents for R&D, ISO based, and GMP based products and coordinate interdepartmental activities including investigations, trainings, and resolve potential product quality issues to improve efficiency. The individual may audit raw material vendors and prepare audit reports. This individual shall adhere to Primrose Bio’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility as defined.

Key Responsibilities

  • Leads implementation, validation, and ensures the ongoing compliance of electronic document management systems (EDMS). Manages document control and acts as subject-matter-expert (SME)
  • Trains EDMS end users and provides first-line technical support
  • Support investigations for change management, product-related deviations, OOS, and CAPAs
  • Responsible for control and inventory supply of GMP/ISO produced materials, including QA retained samples stored at Primrose Bio
  • Develop and present GMP/GDP training sessions for internal employees
  • Prepare presentations for management review of quality systems
  • Provide pertinent data to support quality and compliance metrics and trending
  • Participate, as appropriate, in the evaluation of Primrose Bio’s Quality System and processes for optimization and continuous improvement
  • Other duties as assigned or required

Qualifications

  • BS/BA degree in life sciences, engineering or a related discipline.
  • A minimum of 8 years working in a biotech or pharmaceutical quality assurance environment
  • Excellent working knowledge of national and international pharmaceutical regulations, guidelines and expectations (FDA GMP, EU GMP, EU Directives, ICH Guidelines, etc.)
  • Working knowledge of ISO (9001, 13485) is preferred but not required
  • Must be able to read and interpret complex documentation for compliance with procedures, standards and regulations
  • Clear and succinct writing style; excellent communication skills, both verbal and written
  • Strong observational and listening skills
  • Ability to work collaboratively with people at all levels: operators through the CEO

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    About Primrose Bio

    Founded in 2023 following the merger of Pelican Technology Holdings (formerly Pfenex) and Primordial Genetics, Primrose Bio specializes in developing high-efficiency production systems for innovative and complex biologics. Our technical foundation lies in advanced protein expression and enzyme engineering, and we deploy these technologies in commercially proven platforms. Our advanced manufacturing technologies derisk the path to success for the development of novel therapies.

    We believe in a creative and nurturing environment that allows for constructive and productive interaction between talented people. Good people in a good company will ultimately create superior products that will make a positive contribution to our society and to the health of the planet. Primrose Bio is an equal opportunity employer.

    We offer our employees a comprehensive benefit package including Medical, Dental, Vision, 401k, Paid Time Off, stock options and a dynamic start-up biotech environment with many opportunities for growth.

    Individuals seeking employment at Primrose Bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.

    Primrose Bio is located in the heart of Sorrento Valley in San Diego CA. The company has state-of-the-art laboratory and office space, IT infrastructure and conferencing facilities. 

    If qualified and interested, please apply via LinkedIn, send your CV to careers@primrosebio.com or apply via the form below.

    Apply today

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