- Reference: AJ46510
- Job Type: Permanent
- Location: Westmeath
- Category: General Management
The Vice President of Quality will be responsible for the strategic leadership and successful implementation, execution and maintenance of the Quality program for Ireland’s commercial operations, clinical and manufacturing scale-up and the commercial production, as well as launch of subsequent products
Duties and Responsibilities:
- Create long term Quality strategy for Ireland that is in alignment with Global Head of Quality and the Company’s mission and values and in partnership with the other relevant functions of the Company.
- Accountable for ensuring timely and compliant QC testing and QA batch record review and release of product.
- Develop, implement and maintain quality systems.
- Direct the QC laboratory assuring compliance to testing requirement and specifications that support in-process, product release and stability testing.
- Provide expert technical analysis and evaluation of QA issues, establish risk mitigation and best practice strategy for resolution.
- 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 by Regulatory Authorities.
- Responsible for the implementation of all regulations related to development and commercial supply of pharmaceutical products.
- 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
- Business savvy and resourceful, with the situational acumen to excel in both large corporate environments and smaller entrepreneurial settings
- Proven, repeated success with numerous commercial scale-up and product launch programs
- Strong people leadership capabilities.
For more information or to apply please contact Tina Egan on firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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