* Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. * Maintains a state of ...
60 Katalyst Jobs Hiring in Cambridge, MA
* Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. * Maintains a state of ...
* specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of ...
* specializing in comprehensive CQV (Commissioning, Qualification, and Validation) and engineering solutions tailored exclusively for the dynamic life science industry. We provide a full spectrum of ...
Sr Quality Engineer
$94.20K - $127.70K/yr
Responsibilities: * Provide Quality Engineering support for commercial medical device products. * Develop, modify, apply and maintain quality standards and protocol for processing materials into ...
Sr Quality Engineer
$94.20K - $127.70K/yr
Responsibilities: * Provide Quality Engineering support for commercial medical device products. * Develop, modify, apply and maintain quality standards and protocol for processing materials into ...
Senior Design Quality Engineer
$89.50K - $121.30K/yr
Summary: As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and ...
Senior Design Quality Engineer
$89.50K - $121.30K/yr
Summary: As a Senior Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and ...
Responsibilities: * Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions. * Oversee submission ...
Responsibilities: * Lead and manage publishing activities for IND, NDA, ANDA, Amendments, Supplements, Responses, Annual Reports, Safety Reports, and Promotional Submissions. * Oversee submission ...
* We are seeking a highly skilled and experienced Manager, Quality Analytics to join our Quality Assurance team. This role is pivotal in driving data-driven decision-making and strategic process ...
* We are seeking a highly skilled and experienced Manager, Quality Analytics to join our Quality Assurance team. This role is pivotal in driving data-driven decision-making and strategic process ...
Quality Engineer
$78.40K - $101.20K/yr
Responsibilities: * Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA ...
Quality Engineer
$78.40K - $101.20K/yr
Responsibilities: * Develop, implement, and maintain robust quality management systems aligned with industry standards such as ISO 13485, ISO 9001, and regulatory requirements including FDA ...
Quality Engineer
$78.70K - $101.60K/yr
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a ...
Quality Engineer
$78.70K - $101.60K/yr
We are looking for an experienced CAPA Quality Engineer to drive CAPA initiatives, support project management activities, and communicate effectively across teams. The ideal candidate brings a ...
* The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client. * This role will support quality activities associated within the Small Molecule ...
* The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our client. * This role will support quality activities associated within the Small Molecule ...
Responsibilities: * Client is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays department of CASL. * This role will report directly to ...
Responsibilities: * Client is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays department of CASL. * This role will report directly to ...
CSV Lead / Manager
$17.50 - $21.25/hr
Job Summary: * Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. * The role focuses on driving ...
CSV Lead / Manager
$17.50 - $21.25/hr
Job Summary: * Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements. * The role focuses on driving ...
Technical/Functional Skills : • Medical Device Domain Experience • Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820 • Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis ...
Technical/Functional Skills : • Medical Device Domain Experience • Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820 • Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis ...
Roles & Responsibilities: * Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout ...
Roles & Responsibilities: * Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout ...
Senior Manufacturing Engineer
$92K - $125.80K/yr
: Contract Senior Manufacturing Engineer Reports to: Manufacturing Engineering Manager Department of Manufacturing Engineering focuses on manufacturing at our headquarters in Andover Massachusetts. The ...
Senior Manufacturing Engineer
$92K - $125.80K/yr
: Contract Senior Manufacturing Engineer Reports to: Manufacturing Engineering Manager Department of Manufacturing Engineering focuses on manufacturing at our headquarters in Andover Massachusetts. The ...
Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ...
Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ...
Responsibilities: * Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data ...
Responsibilities: * Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data ...
Associate Scientist is responsible for the development of robust, efficient, scalable and transferable lentiviral vector (LVV) manufacturing for early and late-stage cell therapy programs, for both ...
Associate Scientist is responsible for the development of robust, efficient, scalable and transferable lentiviral vector (LVV) manufacturing for early and late-stage cell therapy programs, for both ...
Job Summary: * The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or ...
Job Summary: * The Veeva Safety Specialist will be responsible for the implementation, administration, configuration, and ongoing support of Veeva Vault Safety solutions within a pharmaceutical or ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
* You are responsible for managing activities related to post-market product safety surveillance and risk management. * Serves as a liaison between Medical Affairs, Clinical Affairs, Research ...
* The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. * GRA serves as the interface ...
* The Global Regulatory Affairs (GRA) is responsible for obtaining approval for new products and ensuring that approval is maintained throughout the product lifecycle. * GRA serves as the interface ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
Job description
Job Description:
- Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.
- Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.
- Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to the company's values and strategic priorities.
- Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.
- Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.
- Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively pro-videos strategic and tactical directions in the mitigation.
- Hosts GCP inspections and provides strategic direction to relevant functions and Subject Matter Experts (SME).
- Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections daily, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management.
- Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed.
- Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome.
- Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections.
- Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc).
- Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quali-ty Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.
- Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management.
- Leads cross-functional continual improvements projects that enable a compliant quality system in the clinical trial delivery quality systems.
- Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
- Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyses results, quality issues and investigation to identify actionable trends and to promote a state of compliance.
- Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e. risk register, KPIs).
- Contributes to any relevant quality and compliance governance in the organization, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.
- BSc in a scientific or allied health/medical field (or equivalent degree).
- Minimum of 10 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data.
- Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance.
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
- Experience must include successful development and implementation of a clinical or pharma-covariance audit program, hosting/leading regulatory inspections and remediation activities on a global level.
- Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.
- Skilled in managing global, cross-functional projects.
- Fluency in written and spoken English, additional language skills a plus.
- Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance.
- Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
- Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.