Compliance Manager jobs in United States, Pennsylvania, West Whiteland Township

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• 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.

• 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

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.

• אחסנת משטחים במערך האוטומטי (עבודה על מלגזה)
• מיון, רישום וקבלת סחורה במחשב על פי נהלים
• ליקוט וביקורת הזמנות ללקוח
• פריקת משאיות ומכולות
• עבודה מול מחשב (Word, Excel, Outlook)
• סביבת העבודה בחלקה הינה חדר קור (טמפרטורה של 5 מעלות בממוצע) וחלקה משרדית מול מחשב
• העבודה במשמרות ( בוקר/ערב)

• חריצות, אחריות, אכפתיות, סדר וארגון ויכולת עבודה בצוות
• נכונות לעבודה במשמרות –חובה (תתכן עבודת לילה לפי צורך)
• נכונות לעבודה בשישי / מוצ"ש במידת הצורך
• נכונות לעבודה בש.נ במידת הנדרש
• נכונות לעבודה במאמץ פיזי ממושך - חובה (זאת בכפוף לתקנות הבטיחות בעבודה ובהתאם לנהלי הבטיחות שיוגדרו באתר). לשם כך על העובד להיות בעל כשירות פיזית וללא מגבלות רפואיות רלוונטיות.
• ניסיון קודם בתחום הלוגיסטיקה / מחסן ממוחשב (עבודה בסביבה ממוחשבת ומסופונים) – יתרון! (יתרון לחברות לוגיסטיקה / תרופות)
• אנגלית ברמה בסיסית – חובה
• רישיון נהיגה - חובה
• רישיון מלגזה – יתרון
• בגרות מלאה – יתרון

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