Senior Manager

4 days ago

Boston, United States Clear Point Consultants Full time

The Senior Manager, GCP Compliance, oversees quality assurance and compliance activities supporting operational quality issues within Good Clinical Practice (GCP) domains. This role will serve as the primary Quality Event Manager for GCP-related events, ensuring compliance with regulatory standards and company policies. The successful candidate will collaborate cross-functionally to drive quality improvement and manage quality events from initiation through to resolution.


Key Responsibilities:

  • Act as the primary Quality Event Manager for GCP-related quality events, ensuring thorough investigation, documentation, and timely resolution.
  • Lead quality assurance processes and compliance activities to support the management of operational quality issues.
  • Develop, implement, and maintain processes and documentation standards for GCP compliance to ensure regulatory requirements are met.
  • Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to address and resolve quality issues.
  • Monitor GCP quality metrics and trends, conducting root cause analyses and implementing corrective and preventive actions (CAPAs) as necessary.
  • Provide expertise and guidance on GCP compliance matters, ensuring adherence to internal policies and external regulatory standards.
  • Lead internal and external audits as required, providing quality assurance expertise and supporting regulatory inspections.
  • Maintain up-to-date knowledge of industry trends, regulatory changes, and best practices in GCP compliance.
  • Manage and mentor a team of compliance professionals, fostering a culture of quality and compliance across the organization.


Qualifications:

  • Bachelor’s degree in life sciences, clinical research, or a related field; advanced degree preferred.
  • Extensive experience in GCP compliance, quality assurance, and event management within the pharmaceutical or biotech industry.
  • Demonstrated understanding of regulatory standards and guidelines, including ICH GCP and relevant FDA and EMA requirements.
  • Proven track record of managing complex quality events, investigations, and CAPA processes in a GCP environment.
  • Strong interpersonal and communication skills, with experience collaborating across functional teams.
  • Leadership experience with the ability to manage and develop a team of quality and compliance professionals.
  • Ability to adapt to changing regulatory requirements and provide strategic guidance on GCP compliance issues.


Additional Skills:

  • Proficiency with quality management systems (QMS) and related software.
  • Strong analytical and problem-solving skills, with attention to detail.
  • Ability to work independently and as part of a team in a fast-paced, dynamic environment.

  • Senior Caregiver for Elderly

    4 weeks ago

    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 IT Manager

    3 weeks ago

    Boston, Massachusetts, United States Insource Services, Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior IT Manager to join our team at Insource Services, Inc. The ideal candidate will have a strong background in IT infrastructure management, technology strategy, and client relationship management.The Senior IT Manager will be responsible for the overall management of client relationships and their IT...

  • Wellness Nurse

    3 weeks ago

    Boston, Massachusetts, United States Senior Living Residences Full time

    Job Summary:The Wellness Nurse is a vital member of our Resident Care team, responsible for managing and directing a comprehensive care program for all residents of our community. This role requires a licensed nurse with experience working with elderly and Alzheimer's populations. The successful candidate will be able to communicate effectively with...

  • Senior Property Manager

    1 month ago

    Boston, Massachusetts, United States 2Life Communities Full time

    Job Title: Senior Property Manager2Life Communities is seeking a highly skilled and experienced Senior Property Manager to oversee the daily operations of our senior housing communities. As a key member of our team, you will be responsible for ensuring the highest level of service and quality of life for our residents.Key Responsibilities:Manage the overall...

  • Senior IT Project Manager

    1 month ago

    Boston, United States Nephin Technologies, Inc. Full time

    Nephin Technologies, Inc. is a Boston, MA-based Technology Design, Consulting and Project Management firm that prides itself on finding progressive solutions to meet the needs of clients. One such project requires us to augment our team to support the delivery of a multi-faceted, multi-year projects with the skills of a Senior Analyst, IT Engineer, and IT...

  • Senior IT Project Manager

    1 month ago

    Boston, United States Nephin Technologies, Inc. Full time

    Nephin Technologies, Inc. is a Boston, MA-based Technology Design, Consulting and Project Management firm that prides itself on finding progressive solutions to meet the needs of clients. One such project requires us to augment our team to support the delivery of a multi-faceted, multi-year projects with the skills of a Senior Analyst, IT Engineer, and IT...

  • Senior IT Project Manager

    4 weeks ago

    boston, United States Nephin Technologies, Inc. Full time

    Nephin Technologies, Inc. is a Boston, MA-based Technology Design, Consulting and Project Management firm that prides itself on finding progressive solutions to meet the needs of clients. One such project requires us to augment our team to support the delivery of a multi-faceted, multi-year projects with the skills of a Senior Analyst, IT Engineer, and IT...

  • Senior IT Manager

    3 weeks ago

    Boston, Massachusetts, United States Insource Services Full time

    Job DescriptionAt Insource Services, we are seeking a highly skilled and experienced Senior IT Manager to join our team. As a Senior IT Manager, you will be responsible for the comprehensive management of assigned client relationships and related IT infrastructures and environments to ensure optimal performance and meet existing and future needs.Key...

  • Senior Pricing Manager

    4 weeks ago

    Boston, Massachusetts, United States FirstPRO Full time

    Job Title: Senior Pricing ManagerFirstPRO is seeking a highly skilled Senior Pricing Manager to play a critical role in our organization's Finance function. This position will provide strategic leadership and problem-solving expertise to drive profitable business growth and success.The ideal candidate will have 7-15 years of experience in negotiation,...

  • Senior Audit Manager

    3 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...

  • Senior Product Manager

    4 weeks ago

    Boston, Massachusetts, United States Motion Recruitment Full time

    Senior Product ManagerBoston, MAThis semiconductor manufacturing company is seeking a Senior Product Manager to lead the development and launch of their Radio-Frequency (RF) product line.The ideal candidate will have experience in product management, specifically in the semiconductor industry, and a strong understanding of RF products.Responsibilities:Lead...

  • Senior IT Manager

    4 weeks ago

    Boston, Massachusetts, United States Boston University Full time

    Job Summary: We are seeking a highly skilled Senior IT Manager to lead our GSDM Client Services team. The ideal candidate will have a strong background in IT management, with experience in recruiting, training, and performance management.Key Responsibilities:Lead the GSDM Client Services team, including directing work, serving as a technical escalation...

  • Senior Sales Manager

    2 months ago

    boston, United States Futerra Talent Full time

    Senior Sales Manager - Industrial/Robotics LiDARSalary: $150-170k + 40% bonusLocation: BostonJoin a leading technology company specializing in LiDAR (Light Detection and Ranging) systems for ADAS, autonomous vehicles, and robotics applications. Their advanced LiDAR solutions empower the automotive industry and other sectors to achieve safer and more reliable...

  • Senior Sales Manager

    1 month ago

    Boston, United States Futerra Talent Full time

    Senior Sales Manager - Industrial/Robotics LiDARSalary: $150-170k + 40% bonusLocation: BostonJoin a leading technology company specializing in LiDAR (Light Detection and Ranging) systems for ADAS, autonomous vehicles, and robotics applications. Their advanced LiDAR solutions empower the automotive industry and other sectors to achieve safer and more reliable...

  • Senior Sales Manager

    1 month ago

    Boston, United States Futerra Talent Full time

    Senior Sales Manager - Industrial/Robotics LiDARSalary: $150-170k + 40% bonusLocation: BostonJoin a leading technology company specializing in LiDAR (Light Detection and Ranging) systems for ADAS, autonomous vehicles, and robotics applications. Their advanced LiDAR solutions empower the automotive industry and other sectors to achieve safer and more reliable...

  • Tax Senior Manager

    4 weeks ago

    Boston, Massachusetts, United States CBIZ Full time

    About CBIZCBIZ is a leading provider of financial and employee business services, delivering national-caliber expertise combined with highly personalized service at the local level.Job SummaryWe are seeking a highly skilled Tax Senior Manager to join our team in New England. As a Tax Senior Manager, you will be responsible for managing staff on assigned...

  • Senior Tax Manager

    3 weeks ago

    Boston, United States Creative Financial Staffing Full time

    Creative Financial Staffing has partnered with a thriving CPA firm in Boston on their search for a Senior Tax Manager. They are a fully integrated firm providing tax, audit and accounting services to a variety of small-mid size privately held clients. The Senior Tax Manager will be responsible for:- Review partnership, corporate, individual, trust, estate...

  • Senior Project Manager

    7 days ago

    Boston, United States Premier Global Links Full time

    ***Please note: We are not accepting C2C (CorptoCorp) applications for this position. Applicants must be U.S. Citizens or Green Card holders and eligible to work on a W2 basis only.***Job Overview We are seeking a skilled Senior Project Manager with extensive experience in the insurance industry to join our IT Project Management Office (PMO) team. This role...

  • Senior IT Manager

    3 weeks ago

    Boston, Massachusetts, United States Massachusetts District Court Full time

    Key ResponsibilitiesThe Massachusetts District Court seeks a highly skilled Senior IT Manager to oversee the technical operations of our systems. The ideal candidate will have a Bachelor's Degree and experience in KACE Servicer maintenance and updates management, Windows AD Administration, and supervisory or managerial roles.BenefitsWe offer a comprehensive...

  • Senior Client Service Manager

    4 weeks ago

    Boston, Massachusetts, United States Boston Consulting Group Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Client Service Manager to join our team at Boston Consulting Group. As a key member of our Client Team, you will play a critical role in strengthening our capabilities in client relationships, sales operations, and account management.Key ResponsibilitiesDevelop and execute strategic plans...