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Executive Director, Head of Quality Assurance
US-MA-Waltham | US-PA-Wayne
Job ID: 2019-2028
Type: Regular Full-Time
# of Openings: 1
Category: Quality – Dept
Radius is a science-driven biopharmaceutical company focused on developing new therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases.
Radius is committed to the research and development of new therapeutics for the large and underserved osteoporosis market. The Company currently has one commercial product as well as abaloparatide in development in transdermal (Abaloparatide-TD) methods of administration for the potential prevention of fractures in post-menopausal women at risk of fracture from osteoporosis.
The Exec Director, Head of Quality is responsible for oversight of all GxP activities at Radius Health. This includes GMP, GCP, GLP, GVP and associated Quality Systems. This position is also responsible for continuous process improvements in the quality area.
- GMP Oversight and compliance to all relevant local requirements of all product through the product lifecycle from development to commercialization:
- Ensures that appropriate equipment, lab computer systems, and method validation are complete.
- Promotes recognition of quality programs among internal and external customers.
- Oversees CMO QA activities of multiple functional areas and manufacturing sites, ensuring consistent application of cGMPs; QSR; ISO 13485, ICH, and other relevant regulations and guidance.
- Organizes internal investigations and assures complete and accurate documentation.
- Reviews and approves documents as required, including protocols, reports, document changes, etc.
- Manages and supports GMP Quality Management Systems.
- Responsible for batch review / batch disposition.
- Oversees Product Complaints.
- Conducts investigations into GMP-related issues and manages QA change control process.
- Supports activities for the R&D departments including, review of draft and executed batch records, release of pharmaceutical products and QA review and approval of product label proofs.
- Oversight of GCP, GLP and GVP QA, including but not limited to oversight of the following activities:
- Maintaining appropriate knowledge, expertise and global experience in the principles and applications of related ICH guidelines
- Vendor, clinical trial site (for GCP) and internal audit planning, conduct, reporting and management of related findings, investigations and CAPAs
- Procedure development
- Identification and monitoring of deviations, investigations and CAPAs
- Inspection Readiness
- Oversight of Radius GxP Quality Management System:
- Controlled Documents: (i.e. policies, Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates and Forms)
- Training Management System including the establishment and maintenance of appropriate training curriculum, assignment, records management and compliance monitoring and reporting
- Oversee selection and fully-validated implementation of a QMS, including authoring, review, approval and tracking of GxP Deviations, Product Complaints, GxP Audits (and their related CAPAs, Investigations and Findings) and GMP Change Control.
- Refine functionality and ease of use of the QMS to meet evolving needs of GMP QA and GCP/GLP QA, as well as Computer Systems Validation QA.
- Oversight of Document Management at Radius Health to ensure compliance with regulatory requirements and corporate SOPs:
- Liaises with Information Technology (IT) to maintain functional requirements for all GxP Quality Systems
- Establish and refine corporate Computer Systems Validation (CSV) procedures, organization and oversight to ensure adherence to 21 CFR Part 11 regulations within Radius Health and any external vendors and partners
- Liaises with Functional Area Leads to identify and design document management procedures that are compliant and integrated into organizational EDMS (and/or, when relevant, paper archives).
- Identify, define and lead implementation of proactive, cross-organizational process improvement and change initiatives to establish and sustain an effective and efficient operational environment across regulated R&D, GMP manufacturing, pharmacovigilance and medical affairs functional areas.
- Bachelor’s degree in scientific discipline required, advance degrees preferred
- Solid understanding of quality management and continuous process improvement principles including global cGMP requirements, ISO 13485, ICH and other relevant regulations is required
- Deep understanding of GCP, GLP and GVP regulations, guidances and principles is required
- Experience in Technology Transfer, Scale up and late phase clinical development.
- Experience with PAI and NDA preparation and inspection readiness
- Understand R&D Development activities in bio pharmaceutical
- 15+ years of relevant GMP/GCP/GXP experience
- Ability to lead quality professionals
- Have the ability to maintain attention to detail while executing multiple tasks.
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.
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