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West Pharma VP Corporate Quality United States, Pennsylvania, West Whiteland Township 550169874
Today
The VP, Corporate Quality, embodies visionary leadership, driving the creation, development and execution of our Corporate Quality strategy and infrastructure, to align with the strategic plan for the West business and Quality. In this strategic capacity, this role will be responsible for ensuring that all elements of Corporate Quality, including the Quality System, meets the needs of customers, the requirements of the applicable global Regulatory bodies, and is scalable as the business continues to grow and evolve.
Essential Duties and Responsibilities
• Strategic mindset that can advance the Corporate Quality functions’ processes, personnel, organizational structure, and goals/objectives for the department to align with West’s strategic plans and be well-positioned to grow and evolve as the company grows
• Demonstrate the advanced expertise to provide the appropriate Corporate Quality oversight to all businesses to identify and address regulatory compliance risks and the associated business risks
• Drive more efficiency and competitive advantage for West by ensuring that the Corporate Quality groups are aligning their efforts and leveraging knowledge and resources from these groups.
• Prepare, manage and deliver the annual budgets for the corporate Quality group
• Collaborate with internal stakeholders across the enterprise to drive a more harmonized/standardized and scalable Quality System that meets the current and future needs of the market and is fit for purpose. Assure that the Quality System is compliant with applicable regulations and standards for the medical device, combination device and medicinal product containment systems industry
• Assist Operation Unit leaders with inspection readiness for USFDA and other Ministries of Health (MoH) inspections or Competent Authority/Notified Body ISO audits. Oversee West’s responses and monthly updates related to any FD-483, Warning Letters, or other significant MoH/NB findings.
• Facilitate the transformation of the Supplier Quality Management (SQM) processes and practices at West incorporating industry best practices, procedures and systems, and ensure proper SQM alignment with Design Controls and Risk Management.
• Evolve the Digital Quality group to ensure ongoing support for QA/RA and to the West enterprise, including identifying ways to utilize Artificial Intelligence to drive efficiencies and competitiveness.
• Ensure that Global Quality Systems platform(s) for Document Control, CAPA, NCRs, SCARs, Complaint Handling, MDR/AER reporting, etc, is fit for purpose and scalable with the growth of West.
• Oversee the standardization and execution of global customer quality agreements and specifications
• Evolve the West global change control process and associated customer notification processes
• Ensure that the Corporate Audit and Corporate CAPA groups are well-aligned to adequately identify and drive closure of enterprise-wise QMS gaps and continuous improvement opportunities
• Evolve the Corporate-level guidance and requirements for Risk Management (including post-market risk assessments/health hazard evaluations) to ensure they meet the requirements of ISO14971 or ICHQ9(a)
• Align various Quality Management Reviews to ensure that QMS data cascades through the organization appropriately and generates the appropriate action plans.
Additional Responsibilities
• Drive Quality Culture focus at West via Quality week, the associated recognition program and other activities
• Act as the emergency back up to the Chief Quality/Regulatory Officer, as needed.
Education
- Bachelor's Degree with concentration in Science, Technology, or Engineering required
- Masters Degree with concentration in Science, Technology, or Engineering highly preferred
Work Experience
Minimum 15 years of Qualityand/or Regulatory Affairs experience required
Minimum 10 years working in a Medical Device/Combination Device/Pharma manufacturing environment required.
Minimum 10 years leading or managing quality and/or Regulatory or Operations preferred.
Preferred Knowledge, Skills and Abilities
- In-depth knowledge of FDA 21CFR parts 820, 3, 4, 11, 7, 803, 806, and 210/211, as well as ISO13485, ISO9001, and EU MDD/MDR requirements, MDSAP, ICH Q10,EU GMP Annex 1
- Strong understanding of Medical Device Risk Management principles and regulatory requirements, such as ISO14971 and ICH Q9 (R1).
- Knowledge of Regulatory requirements for primary packaging materials used with medical devices and pharmaceuticals, including ISO 15378
- Knowledge of Computer System Validation and Data Integrity/21CFR part 11 requirements
- Strong knowledge and experience leading Quality Assurance or Quality Systems functions in the medical device, combination device and/or pharmaceutical industries
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
- Work in manufacturing environments, subject to all gowning and PPE requirements.
- Work in an office environment. At times, must sit for extended periods of time.
- Communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Ability to make independent and sound judgments.
- Observe and interpret situations, analyze and solve problems.
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