Senior Manager, Validation and Compliance

4 weeks ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Summary:

The Senior Manager, Validation and Compliance position will be part of the Vertex Cell and Genetic Therapy Manufacturing Operations and Technical Operations group. This role will oversee Validation personnel and support managing day-to-day Validation operations at VCGT facilities for the T1D program at the greater Boston location. The incumbent will be responsible for managing and supporting personnel for validation of existing equipment and new capital projects, enhancements, and capabilities from conceptual to detailed design, installation, testing, commissioning, qualification, validation, periodic assessments, and revalidation.

Key Responsibilities:
Manage in-house staff and seasonal consultants supporting key CQV deliverables. Manage periodic assessment and revalidation activities as part of Validation Maintenance activities. Participate in design reviews for various capital projects and equipment with cost, efficiency, and compliance always in mind. Lead IQ, OQ, PQ efforts for utilities, facility, and analytical equipment. Coach and mentor reports to assure that the team is attuned with changes in regulatory and industry standards. Perform validation assessments for various projects (change controls, capital projects, etc.). Provide SME support for regulatory inspections from Validation standpoint whenever required. Assist in development of Validation KPIs and ensure they are appropriately monitored, tracked, and reported. Work collaboratively with Manufacturing, Process/Analytical Development, R&D groups, EH&S, Capital Project Management, GIS, QA, and others to support the consistent achievement of the company's strategic objectives and meet aggressive timelines. Manage the Site Validation Master Plan and Requalification Master Plans. Cultivate change and innovation by seeking opportunities to strengthen and improve existing Validation program. Serve as an advisor to reports and involve directly to resolve issues and/or meet timelines. Support activities related to APS program.

Requirements:
Expert knowledge of validation and system implementations in a GMP manufacturing environment. Direct experience with process equipment and systems qualification, sterilization qualification, critical utilities validation, cleaning validation, and temperature mapping is a must. Strong knowledge across technical areas. Has emerging competence in a supervisory role. Demonstrates strong aptitude helping to lead a group or team endeavor and building team unity. Communicates clearly and concisely (written and verbal) across levels of the company. Working knowledge of current applicable regulations, standards, and guidance like 21CFR 210, 211, Part11, ISO 14644, EU Annex 1, ATMP, EU Annex 15, USP, GAMP, etc. Must be able to establish strong working relationships with stakeholders (Quality, DPF, Tech Ops, Engineering, GXP Operations, and GIS) to ensure high-quality deliverables meeting cGMP and Vertex validation requirements. Ability to perform complex assessments for automated processing systems against current industry compliance requirements. Demonstrable team leadership, problem-solving, creative and critical thinking, and project planning skills. Ability to navigate and be successful in a fast-paced, highly matrixed work environment. Displays high competence in the utilization of core quality systems such as change control, deviations, investigations, CAPA management, and document control.

  • Boston, Massachusetts, United States Practical Applications Full time

    Senior Validation EngineerMillstone Medical Outsourcing is seeking a highly skilled Senior Validation Engineer to join its Engineering team. As a key member of the team, you will be responsible for leading the validation process to ensure compliance with regulatory requirements and industry standards.Key Responsibilities:Develop and implement validation...


  • Boston, Massachusetts, United States Practical Applications Full time

    Senior Validation EngineerAt Practical Applications, we are seeking a highly skilled Senior Validation Engineer to join our team. As a Senior Validation Engineer, you will be responsible for leading the engineering team to ensure that all tasks associated with validation activities are completed successfully.Responsibilities:Perform process analysis,...


  • Boston, Massachusetts, United States Diverse Lynx Full time

    Job Title:Validation - Test LeadLocation:RemoteDuration:FulltimeJob Description:At Diverse Lynx LLC, we are seeking a skilled Senior Validation Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the accuracy and reliability of our data validation processes. Key Responsibilities:Develop and implement data...


  • Boston, Massachusetts, United States Diverse Lynx Full time

    Job Title:Senior Validation Lead - Data AnalyticsLocation:RemoteDuration:FulltimeJob Description:We are seeking a Senior Validation Lead - Data Analytics to join our team at Diverse Lynx LLC. As a key member of our team, you will be responsible for leading validation efforts for our data analytics systems. This includes ensuring that our systems meet the...


  • Boston, Massachusetts, United States Argenx Full time

    Compliance Role OverviewArgenx is seeking a seasoned Compliance professional to join our US team as a Senior Manager, US Compliance. This key role will support our commercial and medical operations, ensuring compliance with applicable laws, regulations, and company policies.Key ResponsibilitiesDevelop and implement compliance policies, procedures, and...


  • Boston, Massachusetts, United States KPMG-UnitedStates Full time

    Job Summary KPMG is seeking a highly skilled Senior Tax Compliance Manager to join our Finance and Accounting organization. The ideal candidate will have a strong background in individual income tax compliance and tax law, with excellent written and verbal communication skills. ResponsibilitiesOversee individual income tax compliance, tax counseling, and tax...


  • Boston, Massachusetts, United States U S Compliance Full time

    Job SummaryWe are seeking a highly skilled Environmental Health and Safety Advisor to join our team at U S Compliance. As a key member of our team, you will be responsible for providing technical and regulatory support to our clients in the industrial sector.Key ResponsibilitiesConduct compliance audits, periodic training, and routine facility inspections to...


  • Boston, Massachusetts, United States HarbourVest Partners, LLC Full time

    Job SummaryHarbourVest Partners, LLC is seeking a skilled Senior Associate to support its global compliance program, with a focus on marketing review. As a key member of the compliance team, you will assist in developing, deploying, and enforcing vital policies and procedures. Your expertise will be essential in reviewing marketing materials, website...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Summary:The Quality Manager is a key member of the Vertex Pharmaceuticals team, responsible for ensuring the quality of our pharmaceutical manufacturing processes. This role involves coordinating and executing activities on multiple complex projects, including process validation and technical transfers.Key Responsibilities:Participate in cross-functional...


  • Boston, Massachusetts, United States Northern Trust Full time

    About Northern Trust:Northern Trust is a globally recognized financial institution with a rich history dating back to 1889. We provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by upholding our core values of service, expertise, and integrity.With over 130 years of financial experience...


  • Boston, Massachusetts, United States KPMG Full time

    Business Title: Senior Manager, Business Tax ServicesFunction: Tax ServicesAt KPMG, you can become an integral part of a dynamic team at one of the world's top tax firms. Work with KPMG's extensive network of specialists & enjoy access to our Ignition Centers, where deep industry knowledge merges with cutting-edge technologies to create innovative tax...

  • Senior Test Manager

    4 weeks ago


    Boston, Massachusetts, United States Quantech Services Full time

    Job Title: Senior Test ManagerQuantech Services has an immediate opening for a Senior Test Manager supporting the C3I&N Directorate. Specific duties include:Providing Validation & Verification (V&V) support services in accordance with the program's integrated Test Plan, program development/sustainment contracts, and PMO practices.Providing V&V support...

  • Audit Supervisor

    3 weeks ago


    Boston, Massachusetts, United States Bank of America Full time

    Job Description:As a Senior Compliance Professional on our Audit team, you will be responsible for executing high-level audit work related to financial services, with a focus on compliance and risk management. Your expertise will be essential in assessing business impact, recommending severity ratings, and establishing strong business partner...


  • Boston, Massachusetts, United States HUB International Full time

    About HUB InternationalHUB International is a leading insurance broker that advises businesses and individuals on how to prepare for the unexpected. Our focus is dedicated to providing our customers with the peace of mind that what matters most will be protected through unrelenting advocacy and tailored insurance solutions that put our clients in...


  • Boston, Massachusetts, United States Integra LifeSciences Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Compliance Specialist to join our team at Integra LifeSciences. This role will be responsible for creating quality system documentation and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and maintain quality system documentation, including policies, procedures, and...

  • Validation Specialist

    4 weeks ago


    Boston, Massachusetts, United States Barry-Wehmiller Companies Inc Full time

    About Us:BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from strategy to commercialization.As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep...


  • Boston, Massachusetts, United States Verve Therapeutics, Inc. Full time

    Job DescriptionVerve Therapeutics, Inc. is a clinical-stage genetic medicines company dedicated to solving the global health epidemic of cardiovascular disease. Our mission is to transform treatment from chronic management to single-course gene editing medicines. We are pioneering a new approach to the care of cardiovascular disease, with an initial focus on...


  • Boston, Massachusetts, United States Guardian Angel Senior Services Full time

    About the RoleWe are seeking a compassionate and experienced caregiver to join our team at Guardian Angel Senior Services. As an On Call Caregiver, you will play a vital role in providing high-quality care and support to our senior clients in their own homes.Key ResponsibilitiesProvide exceptional care and support to senior clients, including assistance with...

  • Senior Audit Manager

    4 weeks ago


    Boston, Massachusetts, United States CyberCoders Full time

    Job Title: Sr. Audit ManagerJob Summary:The Sr. Audit Manager will oversee and manage the audit process, ensuring compliance with regulatory standards and internal policies. This role is essential for maintaining the integrity of financial reporting and providing strategic insights to the organization.Key Responsibilities: Lead and manage audit engagements...


  • Boston, Massachusetts, United States New England Design and Construction Full time

    Job Summary:As a Senior Construction Manager at New England Design and Construction, you will oversee 3-4 high-end residential remodeling projects, managing subcontractors and executing high-quality construction projects on time and on budget while ensuring delighted customers. Key Responsibilities: Oversee and manage all aspects of construction projects,...