Manager/ Sr. Manager, Quality Assurance
4 weeks ago
Our vaccine client here in Boston, MA is growing and looking to add a Manager/Senior Manager of Quality Assurance (QC Support) to their team This role as the option to either work hybrid in MA or remotely on the east coast. Role will provide oversight of GMP activities for Quality Control Release and Stability testing including method validation and transfer. Work in partnership with Technical Operations, Quality Control, and GMP suppliers to assure compliance with company's quality standards and global regulatory authority expectations. The responsibilities also include identifying and mitigating product quality and regulatory compliance risks, as well as working to establish Quality Operations processes and controls in compliance with applicable global regulations. Responsibilities include but not limited to:
* Provides direct Quality Assurance oversight and support for the assigned area (e.g. quality control and analytical development).
* Provides quality assurance input to analytical method validation/transfer plans and activities, routine Quality Control release and stability testing, deviation and OOS investigations, stability studies, reference standards, procedures, and processes.
* Ensures all processes contributing to the clinical supply, are conducted in a compliance with applicable regulations and requirements.
* Responsible for compliant, thorough, and accurate review of analytical documents and QA oversight for laboratory investigations.
* Review and approve SOP's and other third party laboratory controlled documents.
* Supports the development and maintenance of quality systems supporting GxP operations.
* Provide quality support to Technical Operations and/or QC functional areas.
* Executes Quality Assurance processes effectively.
* Provides Quality oversight or ownership Quality records (e.g. Investigations, CAPA, Change Controls, SOPs, Quality Plans, Risk Assessments).
* Authors procedures and training materials.
* Reports appropriate Quality metrics and monitors the state of GMP compliance.
Requirements:
* Minimum of a bachelor's degree in biological sciences; advanced degree in biological sciences desirable
* A minimum of 5 years' experience in a pharmaceutical/biologics company with at least two (2) in third party manufacturing QA
* Experience with biologics/vaccines is required.
* Strong understanding of GMP Quality for pre-clinical, clinical, and commercial stage work.
* Demonstrated ability to apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP regulations.
* Highly skilled in root cause investigations, change control, commercial manufacturing oversight and regulatory inspections.
* Location Remote-US East Coast preferred.
* Ability to establish and maintain good working relationships with other functions and levels within the company and with external groups and organizations (vendors, investigators, regulatory authorities, and other stakeholders)
Travel Requirements:
* Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.
* Some international travel may be required.
*
#J-18808-Ljbffr
-
Quality Assurance Manager
1 week ago
Boston, United States Connect Life Science Full timePosition: Contract Quality Manager Location: Boston – Hybrid Duration: 12 Months Contract A medical device manufacturer, bringing a device to the market are seeking a Quality Manager who is a critical thinker, data driven, and quality minded. Job Responsibilities: plan, direct and control the company’s quality system with the project management...
-
Quality Assurance Test Manager
1 week ago
Boston, United States TalentBurst Full timePosition Title: Quality Assurance test Manager Location: Boston MA - Hybrid Position Duration: One Year Plus Hours - 37.5 Per Week Position Summary The BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with *** functional and technical requirements. This role encompasses planning, leading, and...
-
Quality Assurance Test Manager
2 weeks ago
Boston, United States TalentBurst Full timePosition Title: Quality Assurance test ManagerLocation: Boston MA - Hybrid PositionDuration: One Year PlusHours - 37.5 Per WeekPosition SummaryThe BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with *** functional and technical requirements. This role encompasses planning, leading, and executing...
-
Quality Assurance Test Manager
3 days ago
Boston, United States TalentBurst Full timePosition Title: Quality Assurance test Manager Location: Boston MA - Hybrid Position Duration: One Year Plus Hours - 37.5 Per Week Position Summary The BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with *** functional and technical requirements. This role encompasses planning, leading, and...
-
Quality Assurance test Manager
2 weeks ago
Boston, United States Match Point Solutions Full timeJob DescriptionJob DescriptionPosition Title: Quality Assurance test ManagerLocation: Boston MA - Hybrid PositionDuration: One Year PlusHours - 37.5 Per WeekRate : $60/hr C2CClient state of MAPosition SummaryThe BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with *** functional and technical...
-
Senior Supplier Quality Assurance Manager
2 weeks ago
Boston, United States Talnt LLC Full timeAbout the job Senior Supplier Quality Assurance Manager Responsibilities:Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.Oversee combination product development projects, ensuring compliance with quality standards and...
-
Training and Quality Assurance Manager
7 days ago
Boston, United States Pine Street Inn Full timeSCHEDULE: 40 hours, Monday - Friday, 8:00 a.m. - 4:30 p.m. (some evenings and weekends as needed)LOCATION: Remote (with Travel)The Electronic Health Record Specialist is a non-essential position in the event of emergency or weather and will work 100% remote at this time in accordance with the Pine Street Inn Remote Working PolicyJOB DESCRIPTION:SUMMARY OF...
-
Senior Supplier Quality Assurance Manager
2 weeks ago
Boston, United States Talnt Full timeJob DescriptionJob DescriptionResponsibilities:Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.Oversee combination product development projects, ensuring compliance with quality standards and regulations.Manage and oversee the change...
-
Quality Assurance Test Manager
2 days ago
Boston, United States Dice Full timeDice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking the following. Apply via Dice today! Our Client, an independent agency who oversee financial systems as well as manage external single audit, are currently looking to bring aboard as QA Test Manager to their team....
-
Sr Quality Engineer
7 hours ago
Boston, United States ATR International Full timeJob Description: We are seeking a Sr Quality Engineer for a very important client.Responsibilities may include the following and other duties may be assigned Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product Collaborates with engineering and manufacturing...
-
Senior Supplier Quality Assurance Manager
2 weeks ago
Boston, Massachusetts, United States Talnt Full timeResponsibilities: Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities. Oversee combination product development projects, ensuring compliance with quality standards and regulations. Manage and oversee the change control system,...
-
Quality Assurance Test Manager
2 days ago
Boston, United States NavitsPartners Full timeJob Description Job Description Position: Quality Assurance Test Manager Duration: 18-24 months Hours Per Week: 37.5 Location: Hybrid (Boston, MA) Position Summary: The QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with the client's functional and technical requirements. This role encompasses planning,...
-
Sr. PMO Manager
2 weeks ago
Boston, United States Myomo, Inc. Full timeThe Sr. PMO Manager will build and inspire the cross-functional team to create innovative, meaningful, business-impactful products. He/she will ensure that all programs successfully navigate Myomo’s design controls process, ultimately enabling the team to deliver high-quality products to market.ResponsibilitiesManage all the elements of the new product...
-
Director of Quality Assurance
5 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
-
Director of Quality Assurance
5 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
-
Director of Quality Assurance
5 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.As the Director of Quality Assurance, you will be responsible for:Leadership of entire QA function including QA Systems, Quality Ops and Validation Participation in internal/external audits and...
-
Director of Quality Assurance
3 days ago
Boston, United States Walker Cole International Full timeWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. Ready to make your application Please do read through the description at least once before clicking on Apply. As the Director of Quality Assurance, you will be responsible for: Leadership of...
-
Quality Assurance Test Manager
2 weeks ago
Boston, United States NavitsPartners Full timeJob DescriptionJob DescriptionPosition: Quality Assurance Test ManagerDuration: 18-24 monthsHours Per Week: 37.5Location: Hybrid (Boston, MA)Position Summary:The QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with the client's functional and technical requirements. This role encompasses planning,...
-
Quality Assurance Analyst
4 days ago
Boston, United States Karen Clark & CO Full timeQuality Assurance Analyst Karen Clark & Company (KCC) seeks a Quality Assurance (QA) Analyst to join its software team in its beautiful Back Bay Boston office. The QA Analyst will help validate and test RiskInsight®, KCC's catastrophe modeling platform. The QA Analyst will help validate KCC's proven-accurate catastrophe models and software processes and...
-
Quality Assurance Test Analyst
4 weeks ago
Boston, Massachusetts, United States Mindlance Full timePosition Summary The BEST Program Quality Assurance Test Analyst plays a pivotal role in ensuring the quality and compliance of the software solution with Commonwealth functional and technical requirements.Working closely with the QA Test Manager, the QA Test Analyst is responsible for executing tests, validating user roles, and contributing to the creation...
