Site Quality Leader

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

AVP, Digital Analytics

Associate Director RA & QA

HR Systems and Workforce Analyst

Logistics Analyst

Business Intelligence Analyst

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: <ul><li>Own Managerial P&amp;L planning and forecasting, delivering accurate and documented forecasts and budgets</li><li>Lead and own the India FP&amp;A calendar (cross functional view – connected with S&amp;OP and Regional timeline)</li><li>Accountable for managerial P&amp;L reporting in Campari group consolidation system.</li><li>Provide visibility on P&amp;L by SKU / brand / state / channel / customer down to GP and/or CAAP and by account.</li><li>Manage SG&amp;A in collaboration with functional leaders.</li><li>Provide clarity on business performance drivers and variations vs previous forecasts, Budget and prior years</li><li>Pilar of the S&amp;OP process, leading the Volume to value conversion and ensure consistency with commercial planning.</li><li>Provide management relevant and accurate analytics providing visibility on the R&amp;O and as such, enabling effective business decisions.</li><li>Secure integrity of the Depletions/sell out reporting by brand, by state, by channel.</li><li>Understand COGS variances in collaboration with regional supply chain finance team</li><li>Work in close collaboration with controlling team to secure DD and A&amp;P accruals accuracy, documentation and relevance at all time.</li><li>Support Revenue Optimization agenda, partnering commercial team to optimize revenue performance by customers/distributors/channel and maximize profitability.</li><li>Drive internal control &amp; operating efficiency of the promotional program and trade spend.</li><li>Support Key Account managers for trade terms negotiation, providing relevant analytics.</li><li>Develop standardized Value Chain supporting commercial team needs</li><li>Develop sound and reasonable business case for innovation/new product launch/footprint expansion</li><li>Drive ROI analysis for all key initiatives – maximization of investment, share learnings.</li><li>Continually work with functional teams to drive profitable growth and strive for continuous ongoing improvement.</li><li>Drive initiatives through increased focus on the effectiveness and profitability of sales spend and through the proactive identification of profit/growth opportunities.</li><li>Represent finance and challenge financial efficacy in key cross functional forums like Exec reviews, valuation meetings.</li><li>Develop tools to support cross functional team work and decision making and help improvement of internal processes.</li><li>Support projects led by group aiming at improving analytics and efficiencies across finance</li></ul> Requirements: <ul><li>8-10 years experience in commercial finance and FP&amp;A role. Ideally close working experience with sales and marketing/ supply chain in a commercial capacity, preferably in the liquor industry or FMCG.</li><li>Qualification – Chartered Accountant</li><li>Experience in Liquor industry preferred, FMCG essential</li><li>Advanced excel and strong power-point skills</li><li>SAP, Power BI, BPC&nbsp;</li></ul>

Role Description: <ul><li>Quality Control (QC) Officer with hands-on experience in analytical testing and laboratory operations within API, pharmaceutical, or chemical manufacturing industries.</li><li>The candidate should have strong exposure to HPLC and other analytical instruments along with knowledge of GMP/GLP documentation and quality systems.</li></ul> Responsibilities: <ul><li>Perform analysis of raw materials, in-process samples, and finished products as per specifications and SOPs.</li><li>Handle and operate analytical instruments such as: o	High-Performance Liquid Chromatography (HPLC) o	GC o	UV Spectrophotometer o	FTIR o	Karl Fischer</li><li>Conduct wet chemical analysis, titration, LOD, moisture analysis, and related QC activities.</li><li>Prepare mobile phase, standard solutions, reagents, and test samples for analysis.</li><li>Perform calibration and routine maintenance of laboratory instruments.</li><li>Maintain laboratory records, logbooks, COA documentation, and reports as per GMP/GLP guidelines.</li><li>Follow SOPs, safety standards, and quality compliance procedures.</li><li>Support audit activities and maintain data integrity.</li><li>Coordinate with QA and Production teams for quality-related activities.</li></ul> Requirements: <ul><li>Strong hands-on experience in HPLC analysis (Mandatory)</li><li>Knowledge of GC, UV, FTIR, and wet chemistry.</li><li>Understanding of GMP, GLP, SOPs, and documentation practices</li><li>Good analytical and troubleshooting skills.</li><li>Ability to work in rotational shifts and plant environment Preferred Candidate Profile</li><li>Experience in API / Pharmaceutical / Chemical manufacturing industry</li><li>Good exposure to QC laboratory operations</li><li>Strong attention to detail and documentation accuracy</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

Responsibilities: <ul><li>Lead and deliver Digital Measurement Analytics for Digital Platforms in Agile methodology to drive digital data strategy that includes collection &amp; validation of data and reporting.</li><li>Partner with onsite Stakeholders and various process owners in marketing, technology and digital teams to plan and implement strategic priorities.</li><li>Present analytical results and actionable recommendations to key stakeholders on a recurring cadence, and propose innovative analytics solutions to drive business growth and enhance the customer experience.</li><li>Responsible for team’s effective communication, project deliverables, coaching team on adhering to expected timelines, accuracy &amp; compliance with meticulous project management.</li><li>Lead internal initiatives, perform other duties and/or special projects, as assigned.</li></ul> Requirements: <ul><li>Degree in Statistics, Mathematics, Economics, Engineering, or any other quantitative streams with 4+ years of hands-on relevant Analytics experience.</li><li>Minimum 6+ years of relevant work experience in lieu of specified degree.</li><li>2+ years of experience in Digital or Web Analytics Domain utilizing tools such as Adobe or Google Analytics and 2+ years of experience in SAS or SQL.</li><li>1+ years of Experience in Managing People, Coordinating work, Supervising, Evaluating performance and ensuring employees are trained.</li><li>Minimum 1+ years of experience in Data visualizations tools such as Tableau to drive insights.</li><li>Excellent oral and written communication skills with ability to collaborate, articulate and present solutions cutting across functional/agile teams in a simple yet compelling manner</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Overview: <ul><li>The HR Technology and Integration (T&amp;I) organization was established as part of the HR team’s journey through digital transformation.&nbsp;</li><li>Working as part of our Global HR Technology &amp; Integration team this role to Build, implement and improves global HR systems, data, reporting and analytics platform.&nbsp;</li><li>As a product owner you will Develop and improve existing HR systems in partnership with our Global Talent Rewards &amp; HR Services teams to meet business requirements.</li></ul> Responsibilities: <ul><li>Act as a Global Product Owner to support our Global Total Rewards systems &amp; development.</li><li>Partner closely with our Global Total Rewards team to provide product knowledge &amp; solutions.</li><li>Proactively recommend solutions and ideas to help address technical problems that hinder productivity within Total Rewards.</li><li>Collaborates with Total rewards business teams to analyse requirements, develops and implements various solutions &amp; procedures.</li><li>Provides expertise in the analysis, design, development, and implementation of our Global HRIS system &amp; applications.</li><li>Streamline &amp; continuously improve system configuration to support Global Total Rewards team</li><li>Research solutions to support HR programs and processes.</li><li>Acts as a liaison with IT (Internal &amp; External) on technical issues and projects requiring data integration and other technical support.</li><li>Troubleshoots production issues, including problem research and analysis, and performing steps for resolution.</li><li>Documents system specifications, configurations, processes and procedures.</li><li>Partners with IT, HR and business to ensure effective use of methodologies and communication of test strategies, test results and performance through testing teams</li><li>Audits and reviews changes within HRIS to ensure proper controls and separation of duties and assists in establishing new controls, as needed.</li><li>Contributes to training program development and provides Tier 3 end-user support. Partners with COE’s &amp; Shared Services on enhancements, new rollouts, etc.</li><li>Works with external vendors and other service providers to ensure the efficient, accurate, and timely exchange of information</li></ul> Requirements: <ul><li>Bachelor degree (or equivalent); advanced degree preferred.</li><li>Typically requires minimum of 5+ years of SuccessFactors experience with end to end implementation projects</li><li>SuccessFactors certification with experience and expertise in modules like Compensation and Variable Pay</li><li>Hands on experience with SuccessFactors Employee Central (EC)</li><li>Candidate should ideally have been experience in at least 1 previous global / regional implementation • Provided recommendations with half-yearly and periodic system updates</li><li>Ability to communicate recommendations and solutions to non-technical clients and end users.</li><li>Experience building and executing test scripts for HR information system upgrades and enhancements. • Desired ITIL Service Management Certified</li><li>Advanced proficiency in MS Office, especially Excel</li></ul>

Responsibilities: <ul><li>Maintain &amp; report KPIs related to Freight, Duty, Warehousing, and Inventory to drive stakeholder engagement &amp; action.</li><li>Act as a liaison between regional supply chain leaders, Global Logistics, and Finance to collect known headwinds, tailwinds, and cost reduction projects for inclusion in the quarterly consensus forecast</li><li>Track attainment to forecast every month, including Pareto analysis of any misses &amp; gap closure plan</li><li>Challenge existing targets &amp; identify opportunities for further improvements by partnering with the Global Logistics &amp; Global Trade Services organizations</li><li>Drive adherence &amp; standardization in the Premium Freight approval workflow, including training, specific guidelines for customer liability, and data input and reconciliation at the regional level</li><li>Identify and lead a project(s) that directly contributes to freight and/or duty cost reduction</li><li>Develop guidelines for inventory stocking strategy (Make-To-Stock / Make-To-Order), Safety Stock, Lot Sizes</li><li>Collaborate with the Master Data team to review and maintain system parameters in accordance with the latter.</li><li>Lead Slow-Moving / Obsolete inventory cadence &amp; drive actions to completion, including End-of-Life procedure</li><li>Integrate with Corporate initiatives for inventory optimization (ABC/FMR, Healthy Stock methodology)</li><li>Create innovation and digitize reports for better data presentation and action determination.</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Information Systems, or a related field. A Masters degree is preferred.</li><li>Proven experience 5+ years in master data management, data governance, or a related field, preferably in a supply chain planning environment.</li><li>Strong knowledge of supply chain planning processes, including demand planning, inventory management, and production planning.</li><li>Proficiency in utilizing master data management tools and systems (e.g., SAP MDG, Informatica MDM, etc.).</li><li>Solid understanding of data governance principles, data quality management, and data lifecycle management.</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain dashboards and reports using Power BI and or Tableau</li><li>Connect to data sources including data warehouses (for example Redshift), ERP systems, and structured datasets</li><li>Prepare and transform data using Power Query, Tableau Prep, or similar tools</li><li>Build and maintain data models and calculations within BI tools to support scalable reporting</li><li>Translate business requirements into clear and effective visualizations and reports</li><li>Analyze data to identify trends, performance gaps, and opportunities for improvement</li><li>Ensure data accuracy by validating outputs against source systems and established definitions</li><li>Support user acceptance testing and incorporate feedback into reporting solutions</li><li>Maintain and enhance existing dashboards to improve usability and performance</li><li>Document key metrics, business logic, and report structures</li><li>Collaborate with cross-functional teams including business stakeholders and technical partners</li></ul> Requirements: <ul><li>Bachelor’s degree in Industrial engineering, Information Technology, Data Analytics, or related field</li><li>3 to 5 years of experience in Business Intelligence, Data Analytics, or Reporting roles</li><li>Experience developing dashboards using Power BI or Tableau</li><li>Experience working with enterprise data sources such as ERP systems or data warehouses</li><li>Experience supporting business or operational analytics, with supply chain exposure considered an advantage</li></ul>

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213 risk analysis Jobs found

Site Quality Leader

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

AVP, Digital Analytics

Associate Director RA & QA

HR Systems and Workforce Analyst

Logistics Analyst

Business Intelligence Analyst

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213 risk analysis Jobs found

Site Quality Leader

HR PARTNER II

Commercial Finance Manager

QC Officer

EHS Analyst

AVP, Digital Analytics

Associate Director RA & QA

HR Systems and Workforce Analyst

Logistics Analyst

Business Intelligence Analyst

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.