Site Quality Leader

Registered Operations Leader

Commercial Finance Manager

QC Officer

EHS Analyst

Admin Support (Executive Assistant)

Territory Sales Executive

AVP, Digital Analytics

Project Manager

Associate Director RA & QA

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:&nbsp; <ul><li>Manage activities that support business results, revenue growth, client experience and efficiencies in practice.</li><li>Manage resources to achieve business results, including revenue and client acquisition targets.</li><li>Partner with Branch Manager to ensure advisor business plans are completed and marketing events are tracked and measured.</li><li>Assist advisors in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, crafting an agenda and summary of meeting, escorting clients to advisors office and providing follow-up. Prepare and ensure new business paperwork processes are successfully filled out.</li><li>Provide general administrative duties such as answering phones, processing reports, preparing correspondence, setup files, etc.</li><li>Build, manage, track and analyze reports and branch vitals.</li><li>Review advisor expense reports, branch P &amp; L, budgeting, reporting/correcting errors, identify and implement expense reduction opportunities.</li><li>Partner with Registered Principal to ensure compliance support is established and training needs are met.</li><li>Lead real estate and facilities initiatives.</li><li>Lead, coach, mentor and provide performance management for direct reports.</li><li>Partner with Senior Operations Leader and Regional Director of Operations to determine staffing needs; request, hire and allocate staff.</li><li>Conduct 1:1s with staff.</li></ul>﻿Requirements: <ul><li>Bachelors degree or equivalent.</li><li>5 - 7 years relevant experience required.</li><li>Previous successful supervisory experience including knowledge of HR policies and labor laws.</li><li>Excellent written and verbal communication skills; demonstrated ability to motivate team members to delivery results.</li><li>Ability to manage multiple priorities in a fast-paced environment with little or no supervision and strong organizational/time management skills.</li><li>Able to communicate with all levels within the organization.</li><li>Detail orientated, strong math, and analytical skills. Good organization and time management skills.</li><li>Process oriented and can work with a team. Proficient with standard business software applications.</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>To coordinate and facilitate meetings, ensuring accurate documentation through comprehensive minute-taking and timely distribution.&nbsp;</li><li>Manage visa application requests, end-to-end accommodation, travel arrangements, and logistical support for staff and visitors, ensuring efficiency, cost-effectiveness, and a seamless experience.</li><li>Responsible and liaise with 3rd party service providers to ensure timely and compliant processing of Professional Visit Pass (PVP) application for both staff and external vendors.</li><li>Manage with 3rd party service providers to ensure accommodation arrangements for long-stay foreign staff and vendors, including housing setup (apartment, condominium, or staff house), utility provisioning, and food delivery coordination.&nbsp;</li><li>Participate in internal and external audits, ensure timely closure of audit findings with proper documentation and evidence.</li><li>Ensure adherence to company policies and regulatory requirements, maintaining compliance across all administrative and operational activities.</li><li>Coordinating with the canteen service provider to ensure consistent food quality, hygiene and food quantity to meet the daily operation’s needs and to audit canteen timely manner and attend external audit if needed.</li><li>Manage telephone system and deal with service provider if having issue.</li><li>To manage office furniture. To deal with vendor and raise purchase requisition for new added or replacement.</li><li>Actively engage in safety, quality and compliance programs while providing comprehensive administrative support to operations.&nbsp;</li><li>Serve as the primary contact for internal departments and external suppliers in managing administrative matters with efficiency and professionalism.</li><li>Verify and review service provider / vendor billings to ensure accuracy, compliance with contractual terms, and timely processing.</li></ul> Requirements: <ul><li>Degree in business administration or related field.</li><li>Several years of experience working in an administrative role.</li><li>Effective communication skills in multiple languages, both written and verbal to engage with different level of employees and service providers across diverse regions.</li><li>Basic knowledge of office management systems and procedures.</li><li>Proficiency in MS Office (Word, Excel, PowerPoint).</li><li>Ability to handle sensitive information confidentially.</li></ul>

Role Description: <ul><li>Seeking a technically strong and commercially driven Territory Sales Executive to support the execution of strategic account plans at a regional level across Southern Germany, Austria, and Switzerland.</li><li>This role focuses on activating distribution networks, influencing contractors, and ensuring successful deployment of solutions across enterprise customer branches.</li><li>Working closely with the Strategic Account Executive and Enterprise Account Team, you will act as the key link between headquarters strategy and on-the-ground execution across an extensive distributor and contractor network.</li></ul> Responsibilities: <ul><li>Execute the strategy defined by the Strategic Account Executive across assigned regional branches.</li><li>Develop and maintain strong relationships with local and regional distributors within the territory.</li><li>Coordinate closely with Enterprise Account Teams to ensure effective coverage of enterprise and large (Bracket I) accounts, including OEM centers.</li><li>Support and engage approximately 5 key wholesalers (HQ level) and their ~90 regional branches through training and activation initiatives.</li><li>Deliver product training and technical support across distributor branches and contractor networks.</li><li>Work directly with contractors as key influencers in the sales process, ensuring they are equipped to specify and promote solutions.</li><li>Implement channel strategies to drive revenue growth and increase market share through distribution partners.</li><li>Negotiate and manage local agreements, pricing structures, and performance metrics with distributors.</li><li>Conduct regular business reviews with partners to track performance and identify growth opportunities.</li><li>Ensure full alignment and communication between stakeholders across the value chain (HQ, branches, contractors).</li><li>Promote the full portfolio including compression, controls, and electronics as part of a 360° service offering.</li><li>Travel extensively within the assigned region.</li></ul> Requirements: <ul><li>Technical degree or apprenticeship in refrigeration engineering (mandatory: Mechatroniker für Kältetechnik or equivalent).</li><li>Minimum of 5 years’ experience in a technical sales, application engineering, or channel sales role.</li><li>Strong technical understanding of HVAC/R systems, including compressors, controls, and electronics.</li><li>Proven experience working with distributors, wholesalers, and contractor networks.</li><li>Excellent interpersonal and stakeholder management skills.</li><li>Ability to work autonomously while collaborating effectively within a matrix organization.</li><li>Native-level German language skills.</li><li>Strong proficiency in Salesforce or similar CRM systems.</li><li>High willingness to travel across Southern Germany, Austria, and Switzerland.</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>

Responsibilities: <ul><li>Manage and supervise team’s projects’ progress</li><li>Project management– meeting project milestones, cost control/savings for projects and timely project billing.&nbsp;&nbsp;</li><li>Validate suppliers’ quotations are in accordance to site requirements</li><li>Ensure sales team provide the required info to project team for efficient project execution</li><li>Support sales team during bidding phase on project structure presentation and site surveys</li><li>Be clear on project payment milestones and carry out billing timely</li><li>Monthly billing forecasting to reporting manager</li><li>Ensure proper handover to service department with full documentation</li><li>Ensure proper handover documents are submitted to clients for their signatories</li></ul> Requirements: <ul><li>Diploma or Degree in engineering</li><li>10+ years or more in project management responsibilities in low voltage systems</li><li>Experience in managing data centers projects</li><li>Experience in dealing with Contractors, Facilities managers, end users, consultants and managers</li><li>Experience in managing 3rd party subcontractors&nbsp;</li><li>Ability to communicate English with regional counterparts</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>

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118 regulatory reporting Jobs found

Site Quality Leader

Registered Operations Leader

Commercial Finance Manager

QC Officer

EHS Analyst

Admin Support (Executive Assistant)

Territory Sales Executive

AVP, Digital Analytics

Project Manager

Associate Director RA & QA

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118 regulatory reporting Jobs found

Site Quality Leader

Registered Operations Leader

Commercial Finance Manager

QC Officer

EHS Analyst

Admin Support (Executive Assistant)

Territory Sales Executive

AVP, Digital Analytics

Project Manager

Associate Director RA & QA

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

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COMPANY

Contact Us

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