Radius Health, Inc.

Manager, GMP QA

Job Locations US-PA-Wayne | US-MA-Waltham
Posted Date 3 months ago(10/14/2020 11:20 AM)
Job ID
2020-2105
# of Openings
1
Category
Quality - Dept

Overview

Radius Health, Inc. is seeking a GMP Quality Assurance Manager with experience in supporting GMP operations and compliance for solid dosage and/or drug/device combination products in accord with FDA CFR Part 4, 210 and 211, FDA 21 CFR Part 820, EU GMP Volume 4, ISO 13485, ISO 14971, ICH Q7, Q8, Q9 and Q10; performing in a fast-paced environment under tight deadlines.     

 

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
  • Review of master and executed batch records and QC testing for release of commercial and investigational products.
  • 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, temperature excursions and investigations. Ensure adequate root cause analysis as well as identification and implementation of effective CAPA
  • Investigate and document product related complaints that are submitted through the complaint reporting process
  • Prepare and review and QA change control documentation for changes related commercial manufacturing, testing and facilities.
  • Creation and/or revision of SOPs governing GMP QA activities.
  • Generation and implementation of quality agreements. 
  • Perform vendor audits supporting drug product manufacturing and packaging/labeling.
  • Prepare and review plans, protocols, reports associated with Design Control and Risk Management programs.
  • Support preparation of annual product quality review report
  • Support the development of quality systems and associated SOPs
  • Prepare monthly quality metrics for periodic review meetings
  • Identify and escalate compliance issues to Senior Management

Qualifications

  • Solid understanding of pharmaceutical and medical device quality assurance principles including global cGMP requirements, 21CFR Part 4, 210 and 211, 21CFR Part 820 and other relevant regulations.
  • Solid understanding of US and international requirements for Design Control, Risk Management, Supplier Management and CAPA regulatory requirements and guidelines
  • BS in Biology/Chemistry or science related discipline.
  • 5 - 8 years of relevant GMP experience in biopharmaceutical supplier or contract QA with 3 years of experience in a laboratory or manufacturing operations.
  • Investigating pharmaceutical or medical device complaints
  • 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

Work Environment

The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

 

PM18

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