Radius Health, Inc.

GMP Quality Assurance Lead

US-NJ-Parsippany
3 weeks ago
Job ID
2017-1645
# of Openings
1
Category
Quality

Overview

Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Established in 2003 by world-renowned researchers, our history is deeply rooted in science and our research and development efforts are focused on disease areas with significant unmet need for new treatment options to help improve the lives of patients!

 

Radius Health, Inc. is seeking a GMP Quality Assurance Lead who can perform in a fast-paced environment under tight deadlines and who has expertise in assuring compliance with  FDA, GMP and all relevant regulatory requirements

 

The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. The incumbent will execute Quality Assurance and quality system activities with a focus on Radius’ late-phase development and commercial products, ensuring consistent application of cGMPs. Specifically, s/he will have responsibilities for execution of quality systems related to complaint management, complaint investigations, CAPA and deviation management and change management.  

Responsibilities

  • GMP compliance, (to all relevant regulatory requirements), of all products through the product development, regulatory approval and commercialization processes
  • Act as owner of GMP Quality Management System including systems for investigations (manufacturing, complaint), CAPA, change management. Specifically:
    • Prepare and review and QA change control documentation for changes related commercial manufacturing, testing and facilities
    • Investigate and document product related complaints that are submitted through the complaint reporting process
    • Conduct investigations into GMP related issues or problems associated with audits, batch records and complaints. Assists with management of manufacturing deviations, out-of-specification results and investigations
    • Ensure adequate root cause analysis as well as identification and implementation of effective CAPA
  • Support preparation of annual product quality review report
  • Prepare monthly quality metrics for periodic review meetings
  • Support the development of quality systems and associated SOPs
  • Support review of manufacturing and testing records at contract manufacturing sites
  • Identify and escalate compliance issues to Senior Management

Qualifications

  • Solid understanding of pharmaceutical and medical device QA principles including global cGMP requirements, 21CFR Part 210 and 211, 21CFR Part 820 FDA, EU GMP Volume 4, ISO 13485, ICH Q7, Q8, Q9 and Q10.
  • Bachelor’s degree required
  • 5 - 8 years of relevant GMP experience in biopharmaceutical supplier or contract QA
  • Strong administrative skills including Microsoft Office Suite (Word, Excel, PowerPoint)
  • Experience in interacting with multiple functional groups and working on cross functional teams
  • Experience in management and use of electronic quality management systems preferred
  • Ability to travel up to 10% preferred

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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