דרושים Quality Manager ב-West Pharma ב-Ireland, Dublin

• Partner to Commercial, Product Management, Demand Planning and translates strategic supply plans into operational supply plans across a global network of manufacturing sites.
• Execute inventory strategies/models for complex global supply chain networks (make stock, make to finish, make to order), gain alignment and implements recommendations.
• Ensure execution of stocking and planning levels for the network and in alignment with financial goals.
• Establishes product supply across the global network for product(s) within policy guidance and considering life cycle management, technical transfers, network optimizations and potential supply disruptions.
• Identify and recommend future customer pathways for product mfg.
• Drive manufacturing sites regarding necessary adjustments to productions plans to accommodate any forecast changes and assure inventory alignment to strategies; develop measurement systems to track performance.
• Partners with relevant functions to develop risk/contingency strategies and plans for the supply chain network. Drives mitigation plans.
• Supports large-scale global crisis, supply disruption and/or allocation & monitors volumes, partner with Supply Execution team as appropriate.
• Supports Commercial with strategic information for customer interactions.
• Support assessment of new business, sites, etc. and ensure the integration and transition of new products resulting from acquisition as appropriate.
• Participates in developing supply agreements for customers, [to ensure alignment of agreements to delivery feasibility].
• Key leader in the SIOP process who articulates the supply plan and network performance for endorsement, driving decisions via end-to-end analysis and scenario planning.
• Supports new product launches & other life-cycle programs such as cost reduction initiatives, network optimization and/or complexity reduction, technical transfers, site and/or sourcing selection. Assures phased production plans as appropriate and manages inventory conversions
• Supports business process improvement strategies and/or initiatives across the supply chain network in coordination with Center of Excellence (CoE)
• Supports the Strategic Plan and Budget Plan development and communication with stakeholders
• Ensures available capacity for their scope of products both long and mid-term.
• Other duties as assigned.

• Bachelor’s degree with preference for Supply Chain, Engineering, Finance or relevant experience

• Minimum 8-10 years of supply chain experience; preference for global supply planning and or site manufacturing experience

• Experience with LRP/Strategic Planning, Budgeting, New Product Introduction
• Solid understanding of supply planning principles and demonstrated ability to implement process and manage change.
• ERP system knowledge with strong linkage of financial, material and supply flows.
• Experience in pharmaceuticals, medical devices or other regulated industry
• Strong capability to manage through influence and across functions
• Strong leadership and strategic thinking, global mindset; anticipates risks, can successfully navigate ambiguity
• Strong soft skills including high emotional intelligence
• High sense for the business; strong business acumen
• Strong coordination and Project Management skills
• Engages others, builds relationships, and creates networks outside team. Checks in with different people to understand the bigger picture.
• Ability to resolve conflict and tension between P&L vs. Balance Sheet
• Ability to perform root cause analysis and corrective action solutions. Follows through on actions.
• Is curious, agile, engages in new experiences and looks for different perspectives
• Fluent in English and excellent communication (written and verbal)
• Able to comply with the company’s safety and quality policies at all times

• Identify deployment site requirements and solutions within our global SAP template; define gaps and design solutions, with the support of system architects, where required
• Train new users in global processes in coordination with Subject Matter Experts
• Coordinate and support the execution of user acceptance testing and data conversion validation
• Lead workshops and interviews with Subject Matter Experts to identify transformation opportunities
• Manage the transformation portfolio within the Agile framework, linking opportunities to leadership priorities
• Develop, track, and report metrics to articulate change benefit realization
• Lead both direct reports and subject matter experts who work in other departments and functions
• Collaborate with Digital & Transformation team to design and implement resilient business processes enabled by supporting technologies
• Define and communicate change impacts to Finance processes, systems, and structures, and support peer leaders to drive stakeholder engagement, communication, and acceptance of change
• Other duties as assigned

• Bachelor’s degree in Accounting, Information Systems, or related fields, or equivalent experience

• Minimum 10 years of experience in project execution, process design, and/or systems implementation
• Experience with SAP (S/4HANA preferred), specifically with Financial Accounting and Controlling modules

• Strong knowledge of and experience with leading practice budgeting, forecasting, analytics, and accounting principles for the typical business processes of a Life Sciences manufacturing company (Order to Cash, Procure to Pay, Record to Report, etc.)
• Ability to manage change effectively, including strong interpersonal communication skills that can be adapted to various levels of the organization
• Experience with Agile project management framework, and ability to set goals, create sprint plans, track progress, and hold team members accountable for timely delivery
• Experience and/or training in Generative Artificial Intelligence and Machine Learning, SAP BW/BI, Microsoft Power BI, and other tools in the Microsoft Power Platform or similar tools for process automation
• Ability to lead cross-functional teams collaboratively, encouraging resilience and maintaining a positive mindset
• Comfort with ambiguity and the ability to logically structure issues and recommend best practice solutions
• Mindset focused on continuous learning to maintain knowledge of industry trends, new technologies, and evolving best practices

You will be a key strategic partner to our global proprietary business, leading product costing, accounting, and process and system enhancements within the centralized cost accounting COE, supporting West’s Global manufacturing operations across the globe.

We are seeking an experienced leader for this team who has a strong understanding of cost accounting as well as with business process definition, system implementations, and working cross-functionally with the global leadership team. This role is responsible for managing aspects of manufacturing accounting for multiple plants and setting the strategy around costing for the division. This includes developing and monitoring the accuracy of inventory valuation and standard costs in accordance with GAAP requirements as well as month-end financial closing, reconciliations, and reporting.

• Setting strategic goals and long-term objectives within the cost accounting team
• Developing and maintaining policies and procedures within the cost and inventory accounting function and drive consistency and standardization within the wider cost accounting team
• Drive value in West through collaboration with senior leaders to align departmental strategies with organizational goals, and ensure execution on these strategies
• People:• Own inventory valuation and product costing processes within scope of role
• Lead SAP implementation for the FICO module as it relates to plant accounting, product costing, and associated master data as plants transition manufacturing to S4
• Oversee the plant level month end close tasks including the preparation of journal entries, reserve and variance analyses, and account reconciliations for all manufacturing locations supported by the wider cost accounting team
• Responsible for coordinating all the details to develop the annual standard costs in collaboration with FP&A, Supply Chain Planning and Operations
• Ensure appropriate controls and compliance with US GAAP
• Support and assist in the global initiatives relating to cost accounting for all regions/divisions of West
• Support and assist other functions within the business as required

• Bachelor's Degree required

• Minimum 10 years within Cost Accounting with
• Minimum 10 years of post-qualification experience in a manufacturing industry required
• Minimum 5 years of relevant experience as leading the Finance function of a company required

• Extensive knowledge of SAP
• Understanding of the manufacturing environment and the associated financial processes
• Knowledge of supply chain, receiving, inventory flow, operations process and manufacturing principles
• Strong ability to assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem
• Ability to effectively analyze transactional level detail in an enterprise resource planning system and articulate the key findings to senior management
• Ability to multi-task and drive actions to completion under strict deadlines
• Understanding of GAAP and internal control principles
• High proficiency in Microsoft Excel

• MBA, CPA, or CMA
• Prior SAP implementation experience

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Bachelor’s degree in engineering or related science

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

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.

• 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 and manage 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.
• Prepare and deliver the annual budget for Corporate Quality group
• 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.

• 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.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies
• Other Duties as assigned

• Bachelor’s Degree and/or Masters (Preferred) in Science Technology or Engineering.

• Minimum 15 years of Quality experience in the Medical Device / Pharmaceutical industry.
• Minimum 15 years of Quality and/or Regulatory Affairs experience.
• Minimum 10 years working in a Med Device/Combination Device/Pharma manufacturing environment.
• Minimum 10 years leading or Managing Quality and/or Regulatory or Operations.
• Previous experience leading Quality Operations or Operations is very desirable.

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.
• 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.
• Observe and interpret situations, analyze and solve problems.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

• Work in manufacturing environments, subject to all gowning and PPE requirements.
• Work in an office environment.

position itself to meet the requirements of continuing rapid business growth and future market development, West Pharmaceutical Services have developed a transformation strategy of standardization,and centralization of global accounting operations.In accordance withthat strategy,we haveFinancial Centre of Excellence in Dublin, Ireland. Reporting to, and working closely with, the Directorn thisrole, you willresponsible forleading and managing the delivery ofvarious tasksrelated to US GAAP & Local Europeanfinancial statementIn addition, you will develop an understanding of our strategic business direction and play a key role in the future development of the functionnew information

• Coordinate the financial statement preparation, tax provisions and compliance for 15+ local entities.
• Collaboration with external advisors to support the ongoing compliance for local entities.
• Assist in the co-ordination of statutory audits and local compliance filing requirements.
• Responsible for compliance with statutory reporting requirements and deadlines.
• Document all financial statement GAAP bridging activities for each of the local entities.
• Research, document, and provide input on GAAP, statutory accounting, tax, and reporting requirements.
• Ensure compliance with internal policies and procedures and update documentation, as necessary.
• Review of quarterly P&L and balance sheet entries for each local entity.
• Collaborate on and review transfer pricing journal entries and provide input on the processes, as required.
• Work closely with the accounting team and other departments to gather information necessary for task execution.
• People:
  • Lead and mentor a team of professional accountants
  • Focus on talent development, building a strong team
  • Develop a customer-centric culture in your team with highly collaborative relationships with the relevant stakeholders
• Control environment:
  • Ensure that company financial records are maintained in compliance with company policies and US GAAP and SEC reporting requirements
  • Accountable for ensuring that company policies and procedures (internal controls) are implemented to provide reasonable assurance that the company assets are protected
  • Support the Sarbanes Oxley activities relative to internal controls documentation and testing and segregation of duties
  • Liaise with internal and external auditors

• Process, technology and service:
  • Report agreed key performance indicators
  • Support deployment of SAP S/4 HANA and other systems e.g. Blackline to garner greater efficiency within the Record to Report function
  • Support implementation of Artificial Intelligence and /or RPA to drive further efficiency and effectiveness in our delivery of accounting services
  • Acquisitions: Support integration into financial operations
  • Other duties as assigned

• Bachelor's Degree In Accounting or Business with concentration in Accounting/Finance required and
• Master's Degree MBA preferred

• 7+years ofPQEexperiencewith a minimum of3years of management experience

• Qualified accountanti.e.ACA, ACCA,CIMAor CPA

• Public Accounting background
• Previous Shared Service Centre with multinational publicly quoted company experience
• Working knowledge of US GAAP
• Proficient in SAP or similar ERP
• Proficient in MS Office applications
• Experience of BI tools an advantage
• Demonstrated ability to form, lead and develop high-performing teams
• Excellent communication and leadership skills i.e. ability to communicate and work effectively with a wide range of region, division and corporate functions
• Able to manage multiple priorities effectively, while managing ambiguity and adapting to changing business needs and priorities
• Project management, meeting facilitation, written/oral communication and presentation skills
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times