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Manager, QA Doc Control

Escient Pharmaceuticals

San Diego, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Industry: Biotechnology
  • Post Date: 02/11/2024
  • Website: www.escientpharma.com
  • Company Address: 10578 Science Center Drive, Suite 250, San Diego, CA 92121, US

About Escient Pharmaceuticals

Escient is a clinical-stage pharmaceutical company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory diseases. Our pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell-mediated disorders and MRGPRX4 for cholestatic pruritus.

Job Description

$110,000 ‒ $130,000 Annually

Our team is driven by the desire to make a positive difference in the lives of patients. We are passionate about innovative science and strive to discover and develop novel medicines, to bring value to the healthcare ecosystem, and to address significant unmet medical needs. We foster a culture of innovation, collaboration, transparency, mutual respect, and integrity and an environment where employees feel fulfilled by the work they do and are recognized for the contributions they make

Escient Pharmaceuticals is a San Diego based a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Escient is led by an experienced management and scientific team and funded by top-tier life science investors.

The Manager, QA Doc Control is responsible for Quality Systems activities with key responsibilities including document control, training, vendor management and audit support, CAPA and complaint management, and QA project support for manufacturing and clinical programs.

This is a hybrid position that requires to be on-site at least 2 days per week at our San Diego office.

RESPONSIBILITIES:

  • Leads day-to-day document control activities including revising, formatting, tracking, and releasing internal controlled documents.
  • Support the operation of an electronic quality management system (DOT Compliance) and provide administrator support.
  • Manage paper and electronic documentation storage and retrieval processes for the archiving and retention of controlled documents.
  • Oversee and maintain the employee training program
  • Update databases, prepare metrics, identify and communicate trending within the quality management system.
  • Provide QA support and oversight for activities related to CRO manufacturing and clinical study activities.
  • Support audits by regulatory or state agencies, and partners
  • Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures
  • Support other QA department needs as identified by management

REQUIREMENTS:

  • Bachelor’s degree or a combination of relevant education and applicable job experience
  • 5+ years’ relevant industry experience in quality assurance in support of clinical research, product development, regulatory affairs and/or regulatory compliance
  • Prior experience working with electronic document management systems, DOT Compliance experience a plus
  • Strong working knowledge of applicable regulations, guidelines, and industry standards (i.e., ICH-GCP, GLP, and GMP guidelines, FDA, EMA and other international Quality Systems regulations and standards
  • Knowledge of pharmaceutical/biotechnology development processes and auditing practices, a plus
  • Experience in emerging (clinical-development stage) and commercial-stage pharmaceutical companies, a plus

 

Salary Range: $110,000 - 130,000

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