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Sr. Director, Gene Therapy Operational Quality
at Vertex Pharmaceuticals Inc (US)
Boston, MA

Sr. Director, Gene Therapy Operational Quality
at Vertex Pharmaceuticals Inc (US)
Boston, MA

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Description

The Sr. Director of Gene Therapy Operational Quality Assurance (OQA) will lead the build out of the new function and the capabilities in the Quality organization that will be responsible for the Gene Therapy strategic leadership. Additionally, this role will direct the execution of the Operating Management System (OMS) assuring compliance and excellence in quality.
S/he will Support the Site Head in the build out of a new Gene therapy manufacturing site that will support product development, Clinical manufacturing and technical transfer. This individual will provide guidance on establishment of the Regulatory Intelligence and Gene therapy QMS and product release internally manufactured products as well as external CMOs.
S/hewill lead the establishment of the quality Risk management plans that will govern the program management reviews working closely with the business stakeholders and the functions within the Quality organization with the objective of ensuring transparency for gaining insights regarding operational delivery across all GXP functions.
This individual will report to the Head of GXP Operational Quality and will have responsibilities for CMC operations expanding from preclinical, clinical, manufacturing and distribution. This individual will be one who has demonstrated success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality Leadership Team (QLT) engagement.
S/he will partner with all other Quality Management area heads to ensure alignment of strategic and operational goals with priorities of the business and QA for delivery of results necessary to the attainment of ourgoals.

Key responsibilities:

Provide strategic GCP/GMP quality/compliance guidance
  • Build out of a the Quality Systems to support the development, manufacturing and clinical management and oversight of the Gene therapy programs
  • Oversee outsourced CMC activities at CMOs, CROs
  • Build a risk management plan to support manufacturing and clinical activities
  • Communicate effectively with Senior leaders project plans, compliance risks and mitigations

Build capabilities for support of internal facility manufacturing and disposition of starting materials and Drug Product in support of Clinical Studies
  • Responsible for the oversight of the build out of a new facility
  • Responsible for QA Oversight of facilities and utilities in the manufacturing facility
  • Perform QA review of Master and Executed Batch Records
  • Evaluation of Investigations/ OOS/ Change Controls

Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight
  • Build auditing capabilities to support vendor qualifications
  • Establish and maintain Quality Agreements
  • Work with the business areas on vendor selection
  • Participate in Business Review Meetings internally and externally with CXOs

Lead Inspections at Vertex or CMC Contracted Organization
  • Work closely with Regulatory to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
  • Responsible for real time inspection readiness

Support the Regulatory strategy of filing and approval of IND, IMPD, CTA, BLA
  • Evaluate the Regulatory Strategy for compliance with internal source documents
  • Draft, review, and approve relevant sections of regulatory filings

Individual Development/ Training
  • Responsible for talent recruitment and development and maintains a plan that provides for succession and continuity in the most critical positions
  • Establish Goals that aligns with the department and corporate strategies/goals
  • Fosters a culture of innovation, transparency and accountability
  • Develops a superior, high-performing team that meets increasing needs and requirements across the business and helps drive the overall organization forward

#LI-RS1

Minimum Qualifications :

  • Bachelor's degree in a scientific or allied health field (or equivalent degree) plus 15+ years of relevant work experience, or relevant comparable background, or Master's degree and 8-10 years of relevant work experience Experience/knowledge of biologics and/or advanced gene Therapy experience and regulations
  • Comprehensive knowledge of domestic and international GCP and GMP regulations and subsequent regulatory pharmaceutical applications
  • Experience working with Contracted Organizations and management of a manufacturing site

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