Our client is a global pharmaceutical leader in innovation.
The newly created role of Vice President, Quality will be responsible for the strategic leadership and successful implementation, execution and maintenance of Quality program for company commercial operations, clinical and manufacturing scale-up and the commercial production of the company’s lead product as well as launch of subsequent products.
This person will ensure worldwide health authority regulations for pharmaceutical manufacturing are met at this company. The Vice President of Quality will report directly to the Head of Global Quality and will establish and lead the Ireland site Quality Department (QA/QC) function to ensure that all processes, procedures, tasks, and projects are in compliance with cGMP requirements. The position will be based out of the company’s US facility for approximately 1.5 years while construction is underway at our Ireland site.
This position is responsible for the management and coordination of activities required to meet quality and compliance standards. It acts to liaise with other senior executives and staff throughout the organization to ensure that that quality is functioning properly and integrated throughout the operation. Where appropriate, this person will advise on changes and their implementation and provide SOP’s, training, tools and techniques to enable other departments to achieve the company quality and compliance goals.
- Create long term Quality strategy for the company that is in alignment with the company’s mission and values and in partnership with the other relevant functions of the company
- Develop, implement and maintain quality systems aimed at ensuring the compliance to CGMP globally and ISO.
- Drive continuous process improvement activities to improve the overall supply chain performance and ensure adherence to CGMP requirements.
- Direct the QC laboratory assuring compliance to testing requirement and specifications that support in-process, product release and stability testing
- Accountable for ensuring timely and compliant QC testing and QA batch record review and release of product.
- Direct QA and QC activities and programs for internal and third-party supplier. Provide QA oversight of contract organizations.
- Provide expert technical analysis and evaluation of QA issues, establish risk mitigation and best practice strategy for resolution.
- Direct all Corrective Action/Preventative Action (CAPA) investigations (CMC, clinical, nonclinical), and investigations
- Successful management of health authority, Notified body, partner inspections, due diligence and internal audits. Support preparation of clinical trial sites, contract manufacturers, and nonclinical testing laboratories for audits (e.g., Pre-Approval Inspections) by Regulatory Authorities.
- Provide training (GMP, GCP, GLP) to company
- Responsible for the implementation of all regulations related to development and commercial supply of pharmaceutical products
- Champion a Quality Culture in the organization
- Successful track record with Health Authorities around the world
- Ability to communicate effectively at all levels within the corporate environment and with external contacts
- Demonstrate a thorough knowledge of applicable cGMP
- Demonstrated ability to support and put company’s Values into operation
- Demonstrated ability to solve, and help others to solve, complex problems with creativity and innovation
- Excellent verbal, written, and interpersonal communication skills
- Bachelor’s degree in science, engineering or related field is required, with an advanced degree in science, engineering, business or related field preferred
- Motivational, inspirational style with strong influencing skills and innate drive for results
- 10 years of leadership experience in a Quality Assurance/Quality control organization, biopharmaceutical or pharmaceutical, drug GMP, formulation, device and aseptic processing
- Strategic ability and critical reasoning to unify teams around the key issues with the resilience and tenacity to see complex programs through to successful outcomes
- Business savvy and resourceful, with the situational acumen to excel in both large corporate environments and smaller entrepreneurial settings
- A leader of leaders, skilled at attracting the best talent and developing teams in learning agile organizations
- Proven, repeated success with numerous commercial scale-up and product launch programs
- Strong people leadership capabilities
- Broad Quality and Operations experience to include:
- Building of a Quality and Compliance culture
- Preparation for and success with pharmaceutical drug product pre-approval inspections
- Tech transfer processes and program management
- Product launch
- A highly collaborative leader able to excel in a matrixed cross-functional organization
- The ideal candidate for this unique leadership opportunity will be passionate about:
- Making an enormous impact in disease areas that impact millions of people
- Driving the build-out of the organization to commercial scale Quality operations and achieving / sustaining excellence in quality across the company
- Being a key part of a pre-IPO organization that is very well capitalized
NOTE: The new appointee will work closely alongside colleagues at the companies US plant, before transitioning to the company facility in Ireland
Cv to email@example.com 01 2302400