Lead Quality Assurance Manager for Pharmaceutical Validation

7 days ago


Étreux, Hauts-de-France, United States VLink Inc Full time

Job Title: Veeva QMS QA Lead

Location: Boston, MA

Duration: Long Term Contract

About the Role:

This is an exciting opportunity to lead a team of quality assurance professionals in the pharmaceutical industry. As a Veeva QMS QA Lead, you will be responsible for ensuring the validation and quality management of our clients' products.

Key Responsibilities:

  • Quality Assurance: Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements.
  • Team Management: Lead and manage a team of quality assurance professionals, providing guidance and support to ensure they meet their objectives.
  • Validation: Oversee the validation of quality management systems, including Veeva and Trackwise.
  • Regulatory Compliance: Ensure that all activities are conducted in accordance with relevant regulations, including GxP and 21 CFR Part 11.

Requirements:

To be successful in this role, you will need:

  • Education: Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field.
  • Experience: Minimum of 8 years of experience in quality assurance and validation within the pharmaceutical industry.
  • Skills: Extensive experience working with Quality Management Systems (QMS) and tools such as Veeva or Trackwise; strong experience with validation processes and documentation, including IQ, OQ, PQ, and use of HP ALM for test management and traceability.

Salary:$140,000 - $160,000 per year

Benefits:

We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

About Us:

VLink Inc. is a leading provider of quality management services to the pharmaceutical industry. We are committed to delivering high-quality solutions that meet the needs of our clients.



  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Unlock your potential with Takeda Pharmaceutical, a world-class R&D organization dedicated to delivering transformative therapies.About the RoleWe are seeking an experienced Senior Specialist, Engineering and Validation to join our team. As a key member of our cross-functional group, you will be responsible for ensuring equipment is installed, calibrated,...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Company Ltd Full time

    About TakedaTakeda is a world-class R&D organization dedicated to unlocking innovation and delivering transformative therapies to patients worldwide.Job SummaryWe are seeking an experienced Pharmaceutical Validation Specialist to join our team in Boston, MA. As a key member of our team, you will be responsible for ensuring equipment compliance with GxP...


  • Étreux, Hauts-de-France, United States AVEO Pharmaceuticals Full time

    Role Summary:We are seeking an experienced Quality Assurance Director to join our team at AVEO Pharmaceuticals. This key role will be responsible for providing strategic leadership and oversight of quality assurance activities across all stages of product development and commercialization.About the Role:The successful candidate will have a minimum of 10...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    We are seeking a highly skilled Pharmaceutical Research Scientist to join our team at Takeda Pharmaceutical in Boston, MA.Job DescriptionThis role involves working as a Senior Research Associate, Cell Engager Therapies In Vivo Pharmacologist where you will be responsible for the discovery and development of novel therapeutics in the T cell engager space...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a highly skilled Senior Director to lead our Cell Engager Portfolio in Boston, MA. This individual will be responsible for developing and executing research strategies to advance our cell engager programs.Company OverviewTakeda Pharmaceutical is a global pharmaceutical company committed to creating innovative treatments for...


  • Étreux, Hauts-de-France, United States Vertex Pharmaceuticals Full time

    Job OverviewWe are seeking a seasoned Data Engineering Manager to join our Data & Software Engineering Team at Vertex Pharmaceuticals. This is an exciting opportunity for a dedicated professional with expertise in data engineering and pharmaceutical manufacturing to lead critical projects and teams.About UsVertex Pharmaceuticals is a global biotechnology...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job Summary">We are seeking an exceptional Global Pharmaceutical Excellence Leader to join our team at Takeda Pharmaceutical. This role plays a critical part in driving business growth, delivering high-quality research outcomes, and ensuring operational excellence within the Research Strategy and Operations function.">About Us">Takeda is a patient-focused,...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Pharmaceutical Technical Leadership RoleThis leadership position plays a pivotal role in shaping the pharmaceutical industry's regulatory landscape. As a Senior Regulatory Expert, you will lead efforts to define and implement external engagement strategies, governance, and associated capabilities for Takeda Pharmaceutical.Key Responsibilities:Develop and...


  • Étreux, Hauts-de-France, United States PSG Global Solutions Careers Full time

    Are you a seasoned professional looking to leverage your expertise in quality assurance and procedural document management?The OpportunityFoster a culture of excellence by ensuring the effective authoring, revision, and implementation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).Collaborate with cross-functional teams to...


  • Étreux, Hauts-de-France, United States Collegium Pharmaceutical, Inc. Full time

    About CollegiumCollegium Pharmaceutical, Inc. is a leading specialty pharmaceutical company dedicated to improving the lives of people with serious medical conditions.We have a diverse portfolio of medications, including those for severe and persistent pain and ADHD. Our goal is to deliver innovative solutions that make a meaningful impact on our customers'...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    Job OverviewAs a Senior Technical Regulatory Advisor at Takeda Pharmaceutical, you will be responsible for defining and implementing an external engagement strategy, governance, and associated capabilities in line with the company's patient-centric values.The role requires strong leadership experience in Quality/Regulatory/Technical areas, with a minimum of...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    OverviewTakeda Pharmaceutical seeks a highly skilled Project Manager Lead to oversee projects in the area of inflammation research. The ideal candidate will have extensive experience in managing multiple projects simultaneously and collaborating with cross-functional teams.


  • Étreux, Hauts-de-France, United States Aequor Technologies Full time

    About the JobAequor Technologies seeks a highly skilled Quality Assurance Specialist to join our team. This is a challenging and rewarding role that requires a strong understanding of quality principles, regulatory requirements, and manufacturing processes.In this position, you will be responsible for ensuring the quality and compliance of our products and...


  • Étreux, Hauts-de-France, United States Global Channel Management Full time

    About Global Channel ManagementGlobal Channel Management is seeking a Pharmaceutical Data Analyst Lead with strong industry knowledge and experience in data analysis. The salary for this position is approximately $120,000 per year, based on industry standards and location.Job DescriptionThis role involves recording and maintaining relevant information...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About Our CompanyWe are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Our teams are united by an unwavering commitment to deliver better health and a brighter future to people around the world.Job SummaryThe Associate Director, Global Labeling Lead will oversee the development...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    **Job Summary:** We are seeking an experienced Lead Regulatory Expert to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs department, you will play a critical role in shaping the company's global regulatory strategy.**Responsibilities:Develop and implement global regulatory strategies to maximize regulatory success for...


  • Étreux, Hauts-de-France, United States myGwork - LGBTQ+ professionals & allies Full time

    Vertex Pharmaceuticals, a global biotechnology company, is seeking an experienced Data Engineer to lead critical data workloads and support analytics, insights, and curated data access for our Manufacturing teams.The successful candidate will enable and support our rapidly advancing Biopharmaceutical Sciences and Manufacturing Operations (BSMO) organization...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the RoleWe are seeking a highly skilled Senior Neuroscience Biomarker Strategy Lead to join our team at Takeda Pharmaceutical. As a key member of our Bioanalytical and Biomarker Science and Technologies department, you will play a crucial role in developing and driving translational biomarker strategies for preclinical and clinical programs within our...


  • Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is a global leader in transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We are seeking a highly skilled Regulatory Strategy Lead to join our team.This is a senior leadership position that requires expertise in developing and implementing global regulatory...