דרושים Manager Quality Systems ב-West Pharma ב-United States, West Whiteland Township

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Read and interpret data, information and documents
• 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

• Supports the planning and executes compliance and privacy auditing and monitoring activities.
• Supports the daily Data Loss Prevention reviews and communications.
• Manages the day-to-day operations of the annual compliance auditing and monitoring plan.
• Initiates and coordinates corrective and preventive action for areas of noncompliance as identified in the periodic audits and/or through the reporting system.
• Supports the implementation of annual compliance risk assessments.
• Conducts monitoring of AI activities/plans, including but not limited to, support for timely and fulsome assessments of AI pilot/use case requests and supports the AI Steering Committee
• Manages the annual Due Diligence review for agents and distributors
• Supports the Business Compliance & Integrity Department with generating reports used to track and trend activities related to compliance.
• Periodically reviews and recommends updates to compliance policies, procedures and annual compliance auditing and monitoring plan to ensure relevance in providing guidance to management and employees.
• Identifies potential areas of compliance vulnerability and risk, facilitating corrective action plans for resolution.
• Remains abreast of relevant regulatory publications and settlements.
• Collaborates with Chief Compliance & Privacy Officer to develop effective compliance training programs to include new employee orientation, targeted education and ongoing education for management and employees.
  

• Monitors the compliance mailbox, answers questions, and troubleshoots problems for users by phone and email.
• Provides reports as directed and/or requested to the Chief Compliance & Privacy Officer on issues and concerns.
• Collaborates with Chief Compliance & Privacy Officer to develop periodic reports for senior management and the board.
• Assists with the promotion of a compliance culture for the organization.
• Undertake special projects and duties as identified or assigned.

Bachelor's Degree required

• 8-10 years of work experience with 4-7 years of healthcare industry related experience in compliance, operations, privacy, quality, training or applicable experience in pharmaceuticals or medical devices.
• Project Management certification preferred (or experience in lieu of)
• Familiarity with compliance, healthcare and privacy laws and regulations, including but not limited to: FCPA, Anti-Kickback, GDPR, PIPL, EU AI Act and other AI regulations

• Exceptional attention to detail, analytical, and statistical skills.
• Strong written and verbal communication skills.
• Strong organizational and project management skills.
• Strong technology skills including Excel and PowerPoint; and experience creating data analytics preferred.
• Ability to work with and maintain confidentiality of company and personnel data.
• Must be a self-motivated team player with proven ability to identify issues and manage priorities in a fast-paced environment with a bias for action and a strong sense of ownership.
• Must be able to meet deadlines and manage multiple priorities.
• Responsible for identifying system, data, or process improvements that increase efficiency, compliance, or reduce cost to the business.
• Makes recommendations to compliance leadership, develops and supports execution of plans to implement recommendations in conjunction with compliance management.
• Demonstrates an aptitude for critical thinking in complex situations and an ability to synthesize ambiguous data into concrete insights and other duties as assigned.
• 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 and quality policy at all times.
• Preferred experience as a compliance professional responsible for the development and implementation of risk assessments and monitoring and/or audit programs with working knowledge of DOJ’s & OIG’s guidance of an effective compliance program.
• Previous Anti-Kickback Statue compliance risk experience preferred.
• Previous people management experience preferred.
• Review and interpret healthcare compliance regulations, policies, procedures and corrective action plans.
• Ability to be flexible, manage a diverse and demanding workload with minimal supervision.
• Ability to work effectively within a team environment.
• Clear, concise and persuasive writing and presentation skills.
• Decisive and capable of exercising good judgment under pressure.
• Demonstrated ability to problem solve and manage unforeseen changes to plans.
• Excellent interpersonal skills and ability to work as a team player.

• Weekly staggered work schedule to support APAC and Europe

The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.

• Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
• Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements.
• Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
• Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
• Identify and implement meaningful metrics and KPI’s to measure and improve WSS laboratory compliance.
• Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
• Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
• Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.

• Bachelor’s Degree and/or Masters in Science Technology or Engineering.
• Master's Degree preferred

• 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
• Expertise of cGMP requirements, ISO standards and FDA regulations

• Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
• Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
• Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
• Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
• 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.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Thorough understanding of validation activities and risk management principles and techniques
• Fluent in English
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• 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.

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with clients.

• Leading the Engagement (for Contract Manufacturing) and Operations (Contract Manufacturing) by providing proactive change management and motivation of the team.
• Providing differentiating service for key accounts aligned with CM Sales.
• Aligning with Global counterparts to create one global customer experience for all Contract Manufacturing interactions.
• Identifying key customer stakeholders and developing strategies to build trusted advisor relationships.
• Maintaining regular interactions with Sales on all levels to proactively identify potential issues and additional potential opportunities.
• Sharing market insights by gaining understanding on customer requirements and trends.
• Sustaining a sense of urgency across the organization to solve customer issues.
• Overseeing the handling of daily customer interactions professionally.
• Working closely with Technical Customer Support and Sales Account Managers including participation in business reviews, customer specific projects, supply chain meetings etc.
• Assisting in providing reporting to customers: open order schedules, forecast, lead time reports, and sales history, following up on transport queries, Track & Trace
• Ensuring support to the AR team in resolving invoicing discrepancies.
• Process owner for Customer Dialogue whilst still maintaining common sense approach to simple tasks.
• Actively participates in conjunction with Customer Success leadership team driving Global West initiatives and representing the Customer Success team in with fellow leaders across the organization.

• Bachelor's Degree in business or equivalent experience required

• Minimum 8 years in client services or customer service required
• 3-4 years of experience in leading a team in client services or customer service

• Knowledge or experience with ERP tools like SAP with Sales and Distribution
• Ability to deliver great customer experience and to be invigorated by constant personal interaction
• Working knowledge of MS Office or the willingness to learn it quickly with Excel skills being on an intermediate level at minimum
• Highly proficient in written and spoken English
• Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Strong learning capacity
• Ability to work independently in a global environment
• Understanding of Incoterms and Export/Commercial Documentation
• 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 always comply with the company’s safety policy

• Develop strong, cross-functional relationships within West Pharmaceutical’s Integrated Systems Operating Unit to establish the FP&A team as a key strategic partner in decision making.
• Analyze month-end financial results, working closely with the accounting team to ensure accuracy and integrity of financial reporting and resolve any discrepancies.
• Collaborate with the Integrated Systems Unit leader and leadership team to support and guide short-term and long-range planning with comprehensive financial analysis and insights.
• Lead the execution of budget, forecast, and strategic plan models, ensuring precision and alignment throughout monthly, quarterly, and annual processes. Conduct variance analysis to aid in performance evaluation.
• Review and influence strategic investments through comprehensive analysis of capital project business cases and Project Expenditure Request (PER) models, ensuring alignment with business objectives.
• Ensure financial planning aligns with organizational goals by identifying key financial drivers, evaluating risks, and providing actionable insights to support informed decision-making.

• Bachelor's Degree in Finance or Accounting required
• MBA, CPA/CFA strongly preferred

• 10+ years supporting the budgeting, forecasting, and long-term planning for a global, publicly traded business

• Manufacturing industry experience
• Excellent technical and analytical skills in finance, forecasting, financial analysis, and budgeting.
• Understanding of business disciplines to develop, analyze and interpret financial data.
• Executive presence and experience presenting to senior leadership.
• Demonstrated ability to work in a team environment on a global basis.
• Strong influencing and change management skills.
• Present analyses and advocate recommended actions to a variety of audiences with self-confidence.
• Ability to multi-task, prioritize tasks, and drive projects to completion with tight timelines.
• Demonstrated ability to learn quickly when facing problems and ability to apply knowledge to new situations.
• Superior verbal, written and interpersonal communication skills.
• Ability to interact with all levels of the organization, including Executive leadership.
• Strong work ethic and integrity to handle confidential/sensitive information.
• Ability to make recommendations and decisions independently.
• Experience using tools and systems such as SAP HANA, Hyperion, PowerBI, SAP BI, Microsoft Office products etc.
• Ability to lead teams and build effective working relationships both internally and externally.
• Strong presentation, communication, and interpersonal skills.
• Self-starter and results oriented independent worker.
• 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.
• Ability to comply with the company’s safety and quality policy at all times.

• Use written and oral communication skills. Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Read and interpret data, information and documents
• 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
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

• We are seeking a highly motivated and agile Finance Manager supporting the Elastomer & Primary Containment (E&PC) Financial Planning & Analysis (FP&A) Operations team.
• This critical role will be responsible for overseeing financial forecasting, budgeting, and reporting activities related to the SG&A functions in Operations & R&D, supporting the finance team to automate as much of the day-to-day activities and supporting sites with process improvements.
• This role will be 30% ad hoc duties depending on need across the sites.
• The Finance Manager will utilize systems such as SAP, Hyperion, BPC, and BW/BI to analyze data, track performance, budget, forecast to support the business.

• Responsible for all financial analysis, reporting and monitoring of results for VP Global EPC OPS, ENG & Supply Chain & VP R&D Components and containment system Packaging.
• Complete the quarterly financial forecast and annual budget for the Global E&PC Ops & R&D using BPC, proactively identifying financial risks and opportunities.
• Use SAP to gather, analyze, and interpret financial data, ensuring accuracy for month-end closing.
• Prepare and present financial reports and insights to senior leaders.
• Responsible for all monthly, quarterly and annual financial analysis of actuals vs budget/forecast.
• Work with the finance transformation team to help with the digitization leveraging SAP, Power BI and technology lead initiatives
• Lead and support the alignment of the FP&A Operating Model including leading the Playbook document that is always undated.
• Working with Strategy and Network Optimization team along with Cost & Inventory Accounting (CIA) on understanding the best fit of product transfers.
• Interact with cross-functional teams, especially CIA & GFS
• Coordinate and prepare capital project financial models and related business case assessments including CAPEX documents for value Stream meetings and E&PC.
• Assist in identifying and implementing opportunities for process optimization and cost reduction and providing financial insights to support ongoing cost-saving initiatives
• Participate in or lead global/regional FP&A initiatives and other special projects
• Perform ad hoc analysis as needed.

• Education: Bachelor's in Accounting or Finance or equivalent experience
• Experience: 8 years of experience in Accounting and/or Financial Planning & Analysis
• Successful experience in working across multiple levels of an organization including senior leadership

• Exceptional financial acumen including strong analytical, financial modeling, budgeting and forecasting skills.
• Expertise as a financial business partner and strong internal customer service focus.
• Understanding of GAAP and internal control principles.
• Experience of Manufacturing ERP and cost accounting principles.
• Excellent problem solving, process improvement and organizational skills.
• Good interpersonal skills and the ability to present concepts and results in a concise manner.
• Skills in Microsoft Office and business intelligence tools (preferred SAP S/4 HANA).
• Ability to work in a matrixed organization and promote a collaborative environment. Excellent relationship skills and client-focused mindset.
• Excellent oral and written skills; interpersonal skills, fact finder skills, active listening, critical thinking, time management, problem sensitivity and project management skills.
• Ability to leverage technology to improve, analyze and report results.
• Demonstrated ability to work in a complex, dynamic, and challenging environment with strong inherent project execution skills, including prioritizing tasks, balancing workload between multiple projects, anticipating next steps, adapting to changing situations and project scope.
• Ability to comply with the company’s safety and quality policy at all times.

• Medical component and device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility. Must tolerate fumes and from various manufacturing processes
• Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality. Must maintain the ability to work well with others in a variety of situations. Must be able to multi-task, work under time constraints, prioritize and problem solve
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments
• May need to stand or sit for extended periods of time
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary
• Must have good visual acuity. Must be able to see with or without corrective lenses for safety issues
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams. Use written and oral communication skills
• Read and interpret data, information and documents. Ability to make independent and sound judgments. Observe and interpret situations, analyze and solve problems

• Finance and Accounting\Certified Public Accountant (CPA) Upon Hire preferred and
• Finance and Accounting\Certified Management Accountant (CMA) preferred

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