Director, Development GMP Quality Assurance

Waltham MA Radius Health

Radius Health

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Director, Development GMP Quality Assurance

US-MA-Waltham

Job ID: 2019-2010
Type: Regular Full-Time
# of Openings: 1
Category: Quality – Dept

Overview

The incumbent will have responsibility to ensure that all quality management functions are maintained according to GMP requirements. This position will oversee CMO QA activities of multiple functional areas and manufacturing sites with a focus on Radius’ pipeline products, ensuring consistent application of cGMPs; QSR; 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, and other relevant regulations. Serve as the QA subject matter expert supporting Radius CMC development activities including specification development, manufacture and release of investigational products, change management as well as selection, management and audit of suppliers, contract manufacturers and contract testing labs. Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverable, site metrics and company goals.

Responsibilities

  • GMP compliance, (to all relevant local requirements), of all products through the product development and regulatory approval. Work with GCP, GLP, and GMP Quality Assurance Leads and functional area leads to develop and continuously improve GXP-compliant procedures and tools to support quality cycle deliverables, including requirements, deviations, investigations, and CAPAs
  • Promote recognition of quality programs among internal and external customers
  • Overseeing CMO QA activities of multiple functional areas and manufacturing sites, ensuring consistent application of cGMPs; QSR; 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, and other relevant regulations and guidance
  • Execute GMP audits of suppliers, contract manufacturers, contract testing laboratories, manufacturers of investigational products (clinical suppliers) and execute internal audits
  • Manage batch record review and product release for investigational products
  • Manage and provide direction to GMP QA Development Manager
  • Organize internal investigations and assure complete and accurate documentation
  • Identify and escalate compliance issues to Senior Management
  • Review and approve documents as required, including protocols, reports, document changes, etc.
  • Work with functional area leads and partner with Commercial QA team to develop and continuously improve GXP-compliant procedures and tools, including requirements, deviations, investigations, and CAPAs
  • Conduct investigations into GMP-related issues
  • Support activities for the R&D and Technical Operations departments including, review of master batch records, specifications, change controls, test methods, protocols, reports, OOS investigations and deviations.
  • Establish Quality/Technical Agreements with suppliers, contract manufacturers and testing labs

Qualifications

  • Bachelor’s degree is required, advanced degrees preferred.
  • 7 – 10 years’ relevant GMP experience in related industry area is required.
  • Solid understanding of quality management and continuous process improvement principles including global cGMP requirements, ISO 13485, ISO 14971, ICH Q8, Q9, and Q10, and other relevant regulations is required for this role.
  • Experience in Technology Transfer, Scale up, and early phase clinical development is required.
  • Experience with PAI and NDA preparation and readiness planning preferred
  • Ability to travel up to 30% is a requirement for this position.

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.

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.

To apply for this job please visit topspotjobs.com.