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- 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.
- 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)
- Willingness to travel (20-25%) to various meetings or third-party sites, including overnight trips.
- Some international travel may be required.
Manager/ Sr. Manager, Quality Assurance - Boston, United States - HireMinds
Description
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.
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:
Requirements:
Requirements: