דרושים Senior Specialist Product Development R&d ב-West Pharma ב-United States, West Whiteland Township

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s degree or equivalent experience is required
• Master’s degree or PhD in science, math, engineering, or related discipline preferred

• Minimum 5 years of relevant experience
• 2+ years of medical device regulatory experience preferred
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
• Advanced knowledge of ISO 13485
• Advanced knowledge of product life cycle, product development process, design control and change control
• Experience interacting with government agencies
• Excellent oral communication, technical writing, and decision-making skills

• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to verbally communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

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

• 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.

• 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 8 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

In this role, you willbe reporting to the Manager, Internal Audit. You will primarily be executing the testing of the SOX 404 financial controls, with opportunities to support other operational, financial, IT and risk-based audits as necessary. You will lead the development of audit risk assessments, audit planning and audit programs. You will also be responsible for developing and communicating audit report findings and recommendations.

• Testing annual Sarbanes-Oxley Section 404 controls for compliance
• Be the subject matter expert, perform individually or in a team, all phases of audits including planning, fieldwork, reporting results and performing subsequent follow-up procedures
• Assess exposure resulting from ineffective internal controls and provide recommendations to address identified control deficiencies
• Identify root causes and develop audit report findings. Then debrief those findings with the auditees to come up with problem solving recommendations and remediations
• Perform separate audit / SOX projects individually
• Work cross-functionally with other members of the company (Commercial, Supply Chain, etc.) and develop relationships
• Lead third party resources in defined projects in conjunction with audit management
• Participate in other audits and projects (ESG, Cyber Security, Enterprise Risk Management, etc.) as assigned
• Utilize Data Analytic tools such as Power BI to find gaps / anomalies and improvements
• Collaborating on other business and enterprise risk projects, further developing your expertise and broadening your capabilities
• Participate in special projects and other duties as assigned
• Lead and run meetings with the team, auditees and business partners etc.

• Bachelor's Degree in Accounting or Finance or equivalent experience required
• 4+ years of experience with a minimum of 3 years ofprogressive audit experience in Big 4, Regional CPA firm or manufacturing industry

• Experience with global, manufacturing and/or Pharma or Life Science medical device companies is preferred
• Ability to leverage technology to improve results
• SAP or other ERP experience is a plus
• Strong understanding of accounting, finance and auditing areas and concepts
• Proficiency in MS Office, including Word, Excel and PowerPoint
• Excellent written, oral, and presenting skills; active listening, critical thinking, interpersonal skills, fact finder skills
• Analytical mindset with the ability to process and convert vast amounts of data into useful information
• Team player who can work cross functionally.

• CPA or CIA certification either in hand or being actively pursued is required.

• Use written and oral communication skills.
• Read and interpret data, information and documents
• Observe and interpret situations, analyze and solve problems
• Ability to make independent and sound judgments
• 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
• Position operates in a professional office environment. May stand or sit for extended periods of time
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• 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

The Sr Manager, ESG Strategy & Support will act as a key strategic partner in leading and shaping the Environmental, Social, and Governance (ESG) program at West. This pivotal role involves embedding ESG considerations into West's business processes while aligning with its Mission, Vision, and Values. Responsibilities include ensuring compliance with ESG-related laws and regulations such as CSRD, CDP, EU Deforestation, SBTi, CBAM and GRI. The role functions to support the ESG program and involves close collaboration with team members to establish strategies and devise global, regional, and local plans that align with West's Global ESG goals.

• In depth collaboration with internal stakeholders to deliver, drive and execute on ESG goals including Climate strategy; Waste in operations; R&D for the environment; Responsible supply chain
• Serve as the “go-to” ESG subject matter expert for assigned business functions, which may include operations, commercial, supply chain, and research & development projects.
• Champion the creation and release of the annual ESG report, working with Communications and Data Collection and Reporting teams.
• Drive the Science-Based Target Initiative (SBTi) strategy.
• Ensure conformity to global ESG-related laws and regulations (voluntary and mandatory) reporting standards while spearheading program enhancements and monitoring ESG reporting best practices and evolving legislative/regulatory regimes.

• Establish robust procedures and systems for dialogues with internal and external stakeholders concerning ESG issues, including assessment and development of ESG policies, processes, and systems where appropriate.
• Proven track record in analyzing and communicating complex ESG data to a wide variety of stakeholders, delivering strategic insights to senior executives.
• Augment engagement with primary customers and investors, ensuring timely and effective responses to all ESG-related inquiries.
• Tackle other role-related tasks as necessitated by the organization, strictly observing all organizational guidelines, policies, and safety regulations.
• Other duties as assigned.

• Bachelor's degree in environmental or other sciences, or related fields (required).
• Master’s degree in business, environmental sciences or related fields (preferred)

• Minimum 10 years in ESG or sustainability-related roles, with preferred experience in SBTi and emissions calculations (required).

• Familiarity with or experience implementing operational and / or supplier environmental and human rights risk analysis and due diligence processes.
• Experience using and / or implementing Product Carbon Footprint (ISO 14067, PATH) / LCA.
• Demonstrated ability to engage R&D organizations to implement sustainability-related considerations into product development / stage gate processes.
• Have an established network within the ESG community to engage with thought leaders and regulatory bodies.
• Experience with SBTi and Scope 1, 2 and 3 emissions calculations.
• Experience with ESG reporting software such as NASDAQ OneReport, Metrio.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as UN Sustainable Development Goals, CDP, and SASB reporting requirements.
• Advanced level skill in MS Excel, Power Point, Word, and Outlook.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as DJSI and CDP.
• Extremely detail-oriented and deadline driven, with proven track record.
• Excellent communication skills, both written and oral, with proven track record.
• Excellent organizational, administrative, and time-management skills with the ability to work effectively under pressure.
• Exceptional ability to immediately establish credibility with senior executives.
• Ability to independently manage projects and solve problems quickly and effectively.
• Proven ability to cultivate teamwork and fill knowledge or skill gaps where needed.
• Ability to build and maintain strong relationships with customers, business partners, resource managers, and other senior-level executives.
• 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 manage multiple tasks/projects/priorities and simple systems simultaneously.
• Ability to exercise good judgment and maintain a high level of integrity.
• Ability to comply with the company’s safety and quality policy at all times.

• Communication, quick decision making based on logic, circumstances and data at hand, interpreting data, reading or writing, public speaking - must be able to express or exchange ideas with team members.

• Must be able to understand direction and adhere to established procedures.
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
• Maintain the ability to work well with others in a variety of situations.
• Able to learn and apply new information or new skills.

• Read, interpret and analyse data, information and documents.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Must be resilient.
• Demonstrates enthusiasm, takes accountability, is “self-started” and takes initiative for all work and is results driven.

• Overall ownership and accountability for developing, leading and driving new business development for DDD OU product platforms for identified strategic accounts to achieve revenue growth targets for commercial and product development sales.
• Advance the vision for strategic partnerships and customer opportunities as the SME for device services offerings, for all direct assigned accounts and regions. Establish business development programs including early adopter customers, target service levels, and CDAs (Customer Development Agreements).
• Responsible for driving the prospecting and lead development, monitoring sales and funnel performance. Lead and support customer facing teams in key customer interactions/strategic partnerships throughout the selling journey including critical customer/strategic collaboration, presentations, post-sales leadership and problem solving to deliver on revenue and growth targets.

• Bachelor's in Engineering, Science or Business-related discipline

• Minimum 15 years of experience in B2B, Combination Products, Business Development, Product/Program Management.
• Indepth knowledge and experience in pharmaceutical/medical device technical development, sales, marketing or related business.
• Experience in successfully leading global multi-functional or cross-functional teams, in developing cohesive relationships and producing strong business results.
• Excellent communication/negotiation/influencing skills and strong customer focus.
• Excellent commercial and financial acumen.
• Self-starter, highly motivated and ability to work independently with little or no daily supervision.

• MBA or master’s degree preferred
• Background with a good technical understanding and knowledge of Combination products, medical device qualification, primary packaging, Regulatory requirements and Program Management.
• Significant leadership team experience and executive leadership exposure.

The Sr Manager, ESG Strategy & Support will act as a key strategic partner in leading and shaping the Environmental, Social, and Governance (ESG) program at West. This pivotal role involves embedding ESG considerations into West's business processes while aligning with its Mission, Vision, and Values. Responsibilities include ensuring compliance with ESG-related laws and regulations such as CSRD, CDP, EU Deforestation, SBTi, CBAM and GRI. The role functions to support the ESG program and involves close collaboration with team members to establish strategies and devise global, regional, and local plans that align with West's Global ESG goals.

• In depth collaboration with internal stakeholders to deliver, drive and execute on ESG goals including Climate strategy; Waste in operations; R&D for the environment; Responsible supply chain
• Serve as the “go-to” ESG subject matter expert for assigned business functions, which may include operations, commercial, supply chain, and research & development projects.
• Champion the creation and release of the annual ESG report, working with Communications and Data Collection and Reporting teams.
• Drive the Science-Based Target Initiative (SBTi) strategy.
• Ensure conformity to global ESG-related laws and regulations (voluntary and mandatory) reporting standards while spearheading program enhancements and monitoring ESG reporting best practices and evolving legislative/regulatory regimes.

• Establish robust procedures and systems for dialogues with internal and external stakeholders concerning ESG issues, including assessment and development of ESG policies, processes, and systems where appropriate.
• Proven track record in analyzing and communicating complex ESG data to a wide variety of stakeholders, delivering strategic insights to senior executives.
• Augment engagement with primary customers and investors, ensuring timely and effective responses to all ESG-related inquiries.
• Tackle other role-related tasks as necessitated by the organization, strictly observing all organizational guidelines, policies, and safety regulations.
• Other duties as assigned.

• Bachelor's degree in environmental or other sciences, or related fields (required).
• Master’s degree in business, environmental sciences or related fields (preferred)

• Minimum 10 years in ESG or sustainability-related roles, with preferred experience in SBTi and emissions calculations (required).

• Familiarity with or experience implementing operational and / or supplier environmental and human rights risk analysis and due diligence processes.
• Experience using and / or implementing Product Carbon Footprint (ISO 14067, PATH) / LCA.
• Demonstrated ability to engage R&D organizations to implement sustainability-related considerations into product development / stage gate processes.
• Have an established network within the ESG community to engage with thought leaders and regulatory bodies.
• Experience with SBTi and Scope 1, 2 and 3 emissions calculations.
• Experience with ESG reporting software such as NASDAQ OneReport, Metrio.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as UN Sustainable Development Goals, CDP, and SASB reporting requirements.
• Advanced level skill in MS Excel, Power Point, Word, and Outlook.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as DJSI and CDP.
• Extremely detail-oriented and deadline driven, with proven track record.
• Excellent communication skills, both written and oral, with proven track record.
• Excellent organizational, administrative, and time-management skills with the ability to work effectively under pressure.
• Exceptional ability to immediately establish credibility with senior executives.
• Ability to independently manage projects and solve problems quickly and effectively.
• Proven ability to cultivate teamwork and fill knowledge or skill gaps where needed.
• Ability to build and maintain strong relationships with customers, business partners, resource managers, and other senior-level executives.
• 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 manage multiple tasks/projects/priorities and simple systems simultaneously.
• Ability to exercise good judgment and maintain a high level of integrity.
• Ability to comply with the company’s safety and quality policy at all times.

• Communication, quick decision making based on logic, circumstances and data at hand, interpreting data, reading or writing, public speaking - must be able to express or exchange ideas with team members.

• Must be able to understand direction and adhere to established procedures.
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
• Maintain the ability to work well with others in a variety of situations.
• Able to learn and apply new information or new skills.

• Read, interpret and analyse data, information and documents.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Must be resilient.
• Demonstrates enthusiasm, takes accountability, is “self-started” and takes initiative for all work and is results driven.