We are seeking to appoint a Lead Specialist of Document Control and Training to join the US Quality Assurance Team. Based at our Bedford, MA facility, this onsite role is responsible for managing the Document Control and Training programs as part of the Quality Systems and Compliance team.
Oxford Biomedica's Quality Systems and Compliance team is responsible for development, implementation, and oversight of the Quality Management System.
Your responsibilities in this role would be:
The maintenance of Good Manufacturing Practice (GMP) documentation and training systems in compliance with regulatory and quality requirements.
The issuance, processing, distribution, and archival of controlled documents, logbooks, laboratory notebooks, and Quality Control testing numbers.
Ensuring the timely implementation of document change controls and timely release of documentation for production processes and associated activities.
The management of Veeva Vault Training and Quality Docs modules which includes administrative, and configuration changes as required.
The maintenance of employee training files, ensuring files are updated and reflective of employee training requirements.
Providing effective training to new and existing staff on the Quality documentation and training programs.
The maintenance and reporting of training metrics on a quarterly basis for management review meetings.
Providing support for internal and client audits as the subject matter expert for the Documentation and Training department and providing support as part of the Quality audit team.
We are looking for:
Bachelor's degree in Life Sciences is preferred with a minimum of 8 years of experience working in a GMP environment or the equivalent level of work experience in a GMP environment.
Minimum of 2 years of experience within a document control and training function, preferably in a GMP environment.
Previous experience in Veeva Vault Training and Veeva Quality Docs is preferred.
Experience in Microsoft Excel, PowerPoint, and Word is required.
The ability to lead teams and complete projects according to timelines.
Effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.
Strong reasoning skills, organization, and problem solving.
High ethical standards, maintenance of confidentiality.
Strong verbal and written communication skills.
About Us:
Oxford Biomedica is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What's in it for you:
Competitive reward packages
Development opportunities
Welcoming, friendly, supportive colleagues
A diverse and inclusive working environment
State of the art laboratory and manufacturing facilities
We want you to feel inspired every day. We're future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.