-
GMP Quality Operations Specialist
1 week ago
Gardner Resources Consulting Boston, United StatesOur Pharma client is currently searching for a Quality Operations Specialist with expertise in both development and commercialization of products. · The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO's for the clinical/commer ...
-
Senior Manager, Apheresis Quality Operations
4 weeks ago
Vertex Pharmaceuticals Boston, United StatesSenior Manager, Apheresis Quality Operations (Remote) page is loaded · Senior Manager, Apheresis Quality Operations (Remote) · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 5 Days Ago · job requisition id · REQ-21561 · Job Description · Ge ...
-
Director, Apheresis Quality Operations
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · General/Position Summary · The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs. The role will establish the quality risk management plans, work closely with cross-functi ...
-
Quality Assurance Operations Manager
4 weeks ago
Community Phone Boston, United States[Full Time] Quality Assurance Operations Manager at Community Phone Company (United States) | BEAMSTART Jobs · Quality Assurance Operations Manager · Community Phone Company United States · Date Posted · 31 Oct, 2022 · Work Location · Boston, United States · Salary Offered · $4 ...
-
GMP Quality Operations Specialist
2 weeks ago
Gardner Resources Consulting Boston, United StatesOur Pharma client is currently searching for a Quality Operations Specialist with expertise in both development and commercialization of products. The primary responsibility of this position will be to ensure quality oversight of assigned projects/CMO's for the clinical/commercia ...
-
Senior Specialist, GMP Operational Quality
2 weeks ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Prod ...
-
Senior Manager, GMP Operational Quality
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesSenior Manager, GMP Operational Quality (Hybrid) page is loaded · Senior Manager, GMP Operational Quality (Hybrid) · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · REQ-21769 · Job Description · General Summ ...
-
Senior Manager, Apheresis Quality Operations
2 weeks ago
Vertex Pharmaceuticals Boston, United StatesJob Description · General Summary: · The Apheresis Quality Operations Senior Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Senior Manager coordinates or executes activities on multiple complex projects and tak ...
-
Head of Cell Banking Center of Excellence
3 days ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Catheterization Technologist
3 days ago
Travel Nurse Across America Boston, United StatesPut another $10,000 in your pocket when you take 5 assignments. Up to 15 weeks of vacation. For real. · Apply for more details · We're looking for a Registered Cath Lab Technologist (RCVT) for an immediate travel opening in Boston, MA. · The right Cath Lab Technologist should hav ...
-
Associate Director Clinical Trial Management
3 weeks ago
Bicara Therapeutics Boston, United StatesRole Overview · The Associate Director - Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The positi ...
-
Director, Clinical Operations – Inflammation
1 week ago
Monte Rosa Therapeutics Boston, United StatesDirector, Clinical Operations – Inflammation · Location: Boston, MA · Monte Rosa Therapeutics is seeking a highly experienced Clinical Operations professional to lead the successful planning, implementation, and conduct of clinical trials across multiple indications. Reporting to ...
-
Automated Logistic Specialist
3 days ago
US Army Boston, United StatesJob Overview: Become a key player in sustaining our organization's momentum In this mission-critical position, you will oversee maintenance inventory and uphold meticulous maintenance records essential for safe and effective operations. Your new skills to elevate performance qual ...
-
Medical Laboratory Scientist
3 weeks ago
Mindlance Boston, United StatesNo C2C Candidates allowed for this role due to client Limitation · Title : Medical Lab Scientist (MLT/MLS/ASCP/AMT/MLS/MT/MLT) · Location : Wichita, KS/ Mequon, WI/ Warren, WI/ Austin, TX/ Coral Gables, FL/ Melrose, MA/ Logansport, IN. Tulsa, OK/ Indianapolis, IN/ Centerville, TN ...
-
Clinical Data Steward
3 weeks ago
W3R Consulting Boston, United StatesThe Claims Transaction Data, Data Steward is a member of a cross-functional Data Governance team who partners with business, technical, and regulatory partners to ensure the documentation and implementation of Claims Transactions data standards. The Data Steward leads complex, cr ...
-
Sample Coordinator, GMP Operations
4 days ago
HireMinds Boston, United StatesSample Coordinator, GMP Technical Operations · Boston, MA · Our client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will own the end-to-end sample shipment process from CDMO sample shipme ...
-
General Manager
3 weeks ago
Corestaff Services Boston, United States*Fulltime permanent position based in Boston. · Job Description: Operations Manager · As an Operations Manager, you will play a pivotal role in ensuring the smooth functioning of our company's operations. Your responsibilities will encompass a wide range of tasks, from overseeing ...
-
Cloud Automation Engineer
4 days ago
ConsultUSA Boston, United StatesDescription: · Our client has an immediate need for a Cloud Automation Engineer, who will be responsible for enabling engineering teams with guidance and tools to deliver frequent, high quality and reliable components as part of our digital platform · Requirements: · Bachelor's d ...
-
Population Health Coordinator
4 weeks ago
eternalHealth Boston, United StateseternalHealth – Your Forever Partner in Healthcare and Beyond Healthcare is confusing, but it doesn't need to be. A consumer-centric HMO based in Boston, MA, we are a tech-focused start up that is committed to creating long-lasting partnerships with our members, our providers, an ...
-
Clinical Trial Manager
4 days ago
Green Key Resources Boston, United StatesWe are seeking a dedicated Clinical Trials Manager to oversee all aspects of clinical trials, ensuring adherence to timelines, budgets, and quality standards. The incumbent will facilitate collaboration across functional areas and manage relationships with external partners to en ...
Director, Apheresis Quality Operations - Boston, United States - Vertex Pharmaceuticals
Description
Director, Apheresis Quality Operations (Hybrid) page is loadedDirector, Apheresis Quality Operations (Hybrid)
Apply
locations
Boston, MA
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
REQ-21794
Job Description
General/Position Summary
The Director, Cell & Gene Quality, International will support defining the strategy for the international expansion of Cell & Genetic programs.
The role will establish the quality risk management plans, work closely with cross-functional QA, CMC, External manufacturing, Supply Chain and Commercial teams to ensure QA oversight ismaintained.
Key activities include develop, lead and direct the establishment of capabilities for Operational quality managing Cell procurement, and Infusion activities at Apheresis and Infusion centers across Cell & Gene programs.
The role will closely partner with operational stakeholders to lead/support the development and execution of quality projects, quality & technical risk management including execution of associated mitigation plans, and to participate in Cell & Genetic therapies projects and governance committees for EU expansion.
This role will help build the EU/International QA compliance Apheresis expertise that supports Clinical and Commercial C&G Programs.Key Duties & Responsibilities
Establishment of strategic roadmap for quality oversight of VCGT ATC QA in the EU/internationally for innovative therapeutic programs.
Support/Establish ATC Performance Management Reviews across relevant region to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
Serve as a QA trusted advisor/ partner with business stakeholders and as the ATC Leader for Europe and UK office.
Establishment and maintenance of UK Human Tissue Licensing Expertise to ensure compliance requirements are met.For late phase programs, support initial launch and expansion requirements.
Represent Quality in Cell & Genetic Programs for the International Expansion, participate/lead teams to meet and deliver of business & financial priorities and goals.
Support/lead risk management activities, including mitigation plans and associated execution.Provides quality leadership and management for the monitoring of the regulatory and external intelligence for best practices, emerging trends and projection of future capabilities requirements to support Cell & Genetic Therapies programs.
Support/Partner with operational stakeholders for international/EU vendor selection, qualification and oversight.Work closely with the Audit and Inspection Quality Function to establish the audit strategy for Auditing and Performance oversight and support technical Treatment Centers audits.
Work closely with the cross- functional partners to prepare for and support EU Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
In addition, work on providing compliance expertise that supports investigations and CAPA management.Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
Lead and mentor other team members, support development of organizational capabilities and talent building.
Establish long range planning and maintain budget oversight for function.
Required Education Level
Master's degree or relevant comparable background & certifications.
Required Experience
10+ years of experience and 5+ years in a
management/supervisory
role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
Preferred Masters Degree in
pharmaceutical/health
sciences.
Required Knowledge/Skills
·
In-depth EU ATMPs health regulatory agency knowledge, human tissue establishment licensing and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
Broad technical knowledge Tissue licensing and Tissue regulations in the EU and US..
·
Current knowledge of industry trends and best practices in Cell/Gene therapies.
Medical device knowledge a plus.
·
Proven expertise / experience with strategies for gene- and cell therapy products, preparation and inspections.
·
Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
·
Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
Excellent communication skills and a proven track record
Influencing/building/promoting
a culture of Quality and Excellence.
·
Ability to apply risk management principles to decision making and operational priorities.
·
Critical Thinking and Problem Solving skills
Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry.
Other Requirements
~15% Travel may be required.
Hybrid-Eligible Roles
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid:
work remotely up to two days per week;
or select
On-Site
:
work five days per week on-site with ad hoc flexibility.
#LI-Hybrid #LI-ND2
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
Similar Jobs (5)
Director, Packaging, Labeling Quality Operations
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
Associate Director, GCP Operational Quality (Hybrid)
locations
Boston, MA
time type
Full time
posted on
Posted 30+ Days Ago
Sr. Director, Packaging and Labeling Operational Quality
locations
Boston, MA
time type
Full time
posted on
Posted 6 Days Ago
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.
The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease andtransfusion-dependent
beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency
.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.
Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.
Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For.
For company updates and to learn more about Vertex's history of innovation, visitor follow us on
,
Twitter/X
,
,
YouTube
and
.
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.
By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear:
to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
#J-18808-Ljbffr