Jobs
>
Burlington

    Manager, Quality Management - Burlington, United States - PharmaLex

    PharmaLex
    PharmaLex Burlington, United States

    3 weeks ago

    Default job background
    Full time
    Description

    PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management. Through our US, European and Asia-Pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech, and MedTech industries, helping them successfully meet the regulatory compliance challenges during the journey of bringing their products to market and helping them to maintain and sustain Quality Compliance level for products, processes and service providers, according to applicable regulations. PharmaLex has extensive regulatory and scientific experience in all therapeutic areas and product formulations.
    PharmaLex is proud to be an equal-opportunity employer. We respect and seek to empower each individual, and support the diverse cultures, perspectives, skills, and experiences within our workforce. We believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
    As a Key Contributor You Will consistently deliver high-quality services to our clients in the QMC areas (including Auditing, Quality Systems and Compliance, and expert Technical Consulting) by managing, implementing and/or successfully executing projects.
    You will provide Quality Compliance support as for a variety of projects. The individual will be responsible for developing, improving and advising on phase appropriate Quality processes and procedures in compliance with all current GMP and applicable global regulations and guidance. This role will also aid in assessing compliance level with current GMP requirements by performing audits, gap assessments and as requested aiding in remediation efforts for any gaps.
    KEY RESPONSIBILITIES AND ACTIVITIES

    • Engage with clients on scoping calls to aid with defining project needs.
    • Execute Vendor, CMO, and Service provider audits on behalf of clients as needed in the area of expertise, write audit reports, and coordinate with clients on acceptable responses.
    • Assist clients with the development of QMS and Quality Systems SOPs as needed based on the clinical or commercial phase of the product, example SOPs include: document control, batch record review and release, production oversight, investigations, CAPA, change control, complaints, recall, QMR, QRM, Training, vendor management, etc.
    • Assist clients with ensuring robust investigations executed and CAPA/remediations assigned.
    • As needed provide batch review and product release services for clients.
    • Provide technical consulting as needed for client GXP concerns and formalize responses in writing within 1 week period.
    • Assist with compliance gap assessments as needed including Annex 1 reviews and propose remediations for gaps found.
    • Aid in assessing qualifications of additional consulting associates based on the project type needed.
    • Participate in at least one Business Development event per year, including presentations, workshops, podcasts, and creation of published content.
    • Assist with the creation of standardized tools to assist in the development of lean processes.
    • Support assigned work activities for specific QA projects or objectives as required.

    REQUIRED EDUCATION AND EXPERIENCE

    • BA/BS in a Life Science or Chemistry field of study. Microbiology experience is a plus.
    • Minimum of 10 years of experience within a Quality Assurance/Quality Operations role for Aseptic Production of sterile products within the Pharma Industry (e.g. Pharmaceuticals, Biotechnology, Medical Devices, Cell & Gene Therapy), within a global pharma company.
    • 3+ years of experience in a Quality Assurance/Quality Operations Manager role in Pharma industry.
    • Knowledgeable of FDA, EMA, ICH, and other industry guidelines from major regulatory bodies as they relate to cGXP operations, and proven ability to relate these to current operations. Strong familiarity with Annex 1 is a plus.
    • Familiarity with the latest industry practices from benchmarking groups such as ISPE and PDA.
    • Knowledgeable about current global and regional trends in quality management and compliance across the product lifecycle.
    • Demonstrated experience writing SOPs, Policies, and performing the entire Batch Record Review and Product Release process.
    • Experience auditing (internal and external), writing audit reports and designing remediation plans that are fit for purpose related to business and resources.
    • Hands-on experience with Quality Risk Management, execution of Risk Assessments and integrated Quality Systems.
    • Experience working with third parties and effectively using strong interpersonal skills, and negotiation skills to influence and accomplish work.
    • Experience with software related to Quality Management Systems ( eg. Veeva, Master Control, Trackwise, Documentum, ComplianceWire, etc.)
    • The desire and ability to work in a fast-paced, start-up environment.
    • Strong collaboration/teamwork skills, organizational skills, project management and attention to detail.
    • Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders.
    • Ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently.

    Key Performance Indicators

    • Team members' feedback
    • Able to travel 25% - 30%
    • Client Satisfaction
    • Successful delivery of client programs – on time and budget, or appropriately agreed deviations with client
    • Financial performance of service area is within acceptable, agreed KPI's
    • Utilization
  • The University of Vermont Health Network

    Quality Manager

    3 weeks ago

    The University of Vermont Health Network Burlington, United States

    JOB SUMMARY: · The CSR Quality Manager leads quality, compliance and education for UVMMC's CSR department.This role is the primary contact for CSR and high level disinfection process initiation, compliance adherence and tracking of quality and auditing activities. This role util ...

  • The University of Vermont Health Network

    Quality Manager

    4 weeks ago

    The University of Vermont Health Network Burlington, United States

    JOB SUMMARY:The CSR Quality Manager leads quality, compliance and education for UVMMC's CSR department.This role is the primary contact for CSR and high level disinfection process initiation, compliance adherence and tracking of quality and auditing activities. This role utilizes ...

  • DSJ Global

    Senior Quality Assurance Manager

    1 week ago

    DSJ Global Burlington, United States

    Quality Leader required for rapidly growing Weapons Manufacturing/Sporting Good Firm · Location: · Executive Team · Burlington, VT · Job Summary: · A rapidly growing Weapons Manufacturing/Sporting Goods Firm is searching for an experienced Quality Leader to be an integral part ...

  • The Dream Program

    Board and Data Quality Manager

    4 days ago

    The Dream Program Burlington, United States

    Job Description · Job DescriptionSalary: $44,200-$52,995 · The Associate Director of Board & Data Quality is a member of DREAM's Employee & Member Support team. DREAM's Employee & Member Support team strives to fulfill our organization's mission of closing the opportunity gap by ...

  • Tilebar/Soho Studio

    Quality Manager

    3 weeks ago

    Tilebar/Soho Studio Burlington, United States

    **Essential Duties and Responsibilities**:_ · - Develop an incoming quality system to monitor the quality of products to specified standards on their arrival. · - Create detailed, comprehensive, and well-structured process audit plans. · - Estimate, prioritize, plan, and coordina ...

  • Echo Lake Foods

    Quality Assurance Manager

    3 weeks ago

    Echo Lake Foods Burlington, United States

    Echo Lake Foods is a growing organization, seeking an experienced Quality Assurance Manager to join our team. This position requires a knowledgeable and professional individual who works well with all types of employees. · Responsibilities Include: · - Plan, direct, or coordinate ...

  • AMCO Proteins

    Manager of Quality and Safety

    1 week ago

    AMCO Proteins Burlington, United States

    AMCO Proteins is a leading dairy protein manufacturer focused on powder based nutritional and functional solutions for the food, beverage and nutrition markets for over 60 years. With our team of industry experts, we?re positioned to serve customers from the initial stages of pro ...

  • Dairy Farmers of America

    Quality Manager

    28 minutes ago

    Dairy Farmers of America St Albans, United States

    **Position** : Quality Manager · **Location** : St. Albans, Vermont · **Requisition ID:** : 26502 · Manage and lead a team of individuals to ensure effective quality execution, continuous improvement, and regulatory compliance. Provide leadership within the facility to drive p ...

  • SilverWorks

    Employee MB Rent

    1 week ago

    SilverWorks Chittenden, United States

    With 100 years of automotive tradition, the company Russ Jesinger Automobile GmbH & Co. KG is known for premium sales and service of top quality at six locations in the district of Chittenden (Dettingen/Teck, 3x Esslingen, Filderstadt and Nürtingen). We are an authorized sales pa ...

  • BlueSky Innovations

    Occupational Safety Specialist as a Process Facilitator for Operational Excellence"

    1 week ago

    BlueSky Innovations Burlington, United States

    Your Responsibilities · Ensuring compliance with fire protection, health and safety regulations for the location · Acting as a link between quality, production and customers with the goal of continuously improving processes, products and communication · Establishing and implement ...

  • Infinity Technologies

    Training as a commercial clerk for traffic services at the train station in 2024

    1 week ago

    Infinity Technologies Burlington, United States

    Burlington is one of the most diverse employers in Germany. Every year, we are looking for over 5,000 apprentices in 50 different professions who want to grow and improve with us. We are currently seeking a candidate for a 3-year apprenticeship as a Traffic Service Clerk at our O ...

  • Stellar Ventures

    A DevOps Engineer is a professional who specializes in the practices and tools used to automate and streamline the processes between software development and IT operations

    1 week ago

    Stellar Ventures Burlington, United States

    FEIG ELECTRONIC is an innovative, owner-managed, medium-sized company and has been one of the leading manufacturers of microelectronic products in the areas of payment, RFID, traffic sensors and control electronics for over 50 years. At our company, you can experience development ...

  • Stellar Innovations

    Salesperson with locking function

    1 week ago

    Stellar Innovations Winooski, United States

    Location: 65346 Eltville / Erbach | Contract type: Full-time/Part-time, temporary | Job ID: 834720 · What you'll be doing with us: · Do you love it when your guests feel right at home? And always give them your full attention? With ease, you convey to our customers in sales and a ...

  • Century Arms

    quality assurance manager

    3 weeks ago

    Century Arms Fairfax, United States

    Job Description · Job Description · Summary of Position · The Quality Manager position at Century Arms has the primary objective of establishing and maintaining high level quality standards, optimize production processes, and minimize defects or error in the manufacturing and a ...

  • Century Arms

    quality assurance manager

    3 weeks ago

    Century Arms Fairfax, United States

    Job Description · Job DescriptionSummary of Position · The Quality Manager position at Century Arms has the primary objective of establishing and maintaining high level quality standards, optimize production processes, and minimize defects or error in the manufacturing and assem ...

  • Northwest Regional Planning Commission

    Project Manager- Water Quality

    2 weeks ago

    Northwest Regional Planning Commission Saint Albans City, United States

    Are you interested in working on community scale projects that help improve water quality and the natural environment? Do you like working in the field to identify project opportunities? Are you equally comfortable collaborating with partners to ensure a project is designed well ...

  • Irving Knight Group

    Quality Manager

    1 week ago

    Irving Knight Group St Albans, United States

    Title: · Quality Manager - Kitchen & Bathroom Cabinets · Plant location: · Middle Georgia (relocation provided) · Salary: · $70,000 - $100, % Bonus · Responsibilities: · - Lead the development, implementation, and continuous refinement of the quality assurance program across a ...

  • Dairy Farmers of America

    Quality Manager

    4 days ago

    Dairy Farmers of America St. Albans, United States

    Manage and lead a team of individuals to ensure effective quality execution, continuous improvement, and regulatory compliance. Provide leadership within the facility to drive positive change through influence and example. In conjunction with plant operations, build and maintain ...

  • Burlington Health and Rehabilitation Center - Burlington, VT

    Unit Manager

    3 weeks ago

    Burlington Health and Rehabilitation Center - Burlington, VT Burlington, United States

    Benefits · *Nursing Student Loan Debt Repayment and Tuition Assistance · *Variable compensation plans · *Tuition, Travel, and Wireless Service Discounts · *Employee Assistance Program to support mental health · *Employee Foundation to financially assist through unforeseen hardshi ...

  • Burlington Health and Rehabilitation Center - Burlington, VT

    Unit Manager

    2 days ago

    Burlington Health and Rehabilitation Center - Burlington, VT Burlington, United States

    Benefits · *Nursing Student Loan Debt Repayment and Tuition Assistance · *Variable compensation plans · *Tuition, Travel, and Wireless Service Discounts · *Employee Assistance Program to support mental health · *Employee Foundation to assist financially with unforeseen hardships ...