Quality Assurance Documentation Manager
ABOUT ADICET BIO
Adicet’s pipeline comprises next generation allogeneic gamma delta T cell-based immunotherapies and TCR-like antibody therapeutics. Adicet’s gamma delta T cell therapies are genetically modified to target tumor populations via proprietary chimeric antigen receptors or T cell receptors and represent a novel approach to overcoming challenges that can limit the efficacy and safety of alternative immunotherapies. Adicet’s TCR-like antibody platform is uniquely positioned to identify and validate novel disease specific peptide-MHC targets that cannot be effectively targeted by conventional anti-tumor antibodies.
Adicet Bio was founded in late 2015 with significant investment from OrbiMed, Novartis Venture Funds and Pontifax. In August 2016, Regeneron and Adicet Bio announced a strategic collaboration to discover and develop next-generation engineered immune-cell therapeutics and in September 2016, Adicet Bio was recognized and named by FierceBiotech as a “Fierce 15” Biotech Company of 2016.
QUALITY ASSURANCE DOCUMENTATION (QAD) MANAGER
The QAD manager is responsible for establishing the GMP Document System to support cell therapeutic products development from early phases to commercialization. You will be responsible for maintenance of document/record life cycle management within the document control archive, in a compliant and secure manner per cGMP regulatory requirements and Adicet Quality Manual. In addition, you will be responsible for establishing and maintaining the Adicet training program.
The position will report to the Sr. Director of Quality and may manage others, such as contractors.
1. Establishing the GMP Document System to support cell therapy drug development
o Write or revise corporate guidance procedures covering various systems per the Adicet quality manual and/or Adicet senior management determination.
2. Managing the life-cycle of documents (creation, distribution, revision, review cycle, implementation) including periodic review cycles.
o Issue document numbers/templates, reconcile, file, and archive technical protocols/reports, validation protocols/reports.
o Maintain information accurately following GDP to support operations and overall life cycle of documents and records.
o Review documents to ensure adherence to the format requirements and the effective template.
o Manage the distributed documents and ensuring that the documents are the current version; ensure the integrity and consistency of the distributed documents.
o Manage daily use, borrow, and check of the documents issued to their department.
o Manage the Document Change Control process: GMP document initiation, revision and retirement. And ensure changes to the GMP documents are linked to our training program.
3. Control of GMP Documents
o Ensure GMP documents and records are retained in a secure location with consideration given to the prevention of fire and water damage as well as loss prevention.
o Maintain and follow Adicet procedures for issuance, receipt, reconciliation, filing, and archives on-site and/or off-site.
o Ensure Superseded versions of GMP documents are retained along with current effective versions.
o Assure only the current, effective version of a GMP document is employed at the point of use.
o Controlled copies of GMP documents are distinguished from uncontrolled copies by use of watermarks, stamps or other visible means.
4. GMP Document Archiving and Retention
o Manage all GMP document periods of retention, including on-site and off-site storage: the documents may be in the form of original paper records, logbooks, electronic records, and or authenticated copies obtained by photocopy, photography, electronic scanning or other suitable means.
o Manage the site’s retention schedule and archival process to ensure that documents are appropriately retained, retrievable and destroyed.
5. Establish and maintain the Adicet training program
o Create and maintain training items, training curricula and training assessments.
o Manage following training functional parts: training materials, training method, trainer qualification, training plan and training records and training evaluation.
o Work with SMEs in developing On the Job Training and in managing the Training Effectiveness program.
o Manage the process for the filing and retrieval of completed Training Records.
o Ensure that training curricula are appropriately updated per changed GMP documents.
o Assists in the development and maintenance of training content, training curricula and metrics in compliance with policies, procedures, and applicable regulations.
- BS degree in a scientific discipline.
- 5+ yrs experience in GMPs at an operational level supporting manufacturing or testing in small or large pharmaceutical environments.
- 4+ yrs experience in establishing a GMP document system and managing the document lifecycle.
- 3+ yrs experience supervising contractors, consultants and/or direct reports.
- Experience in Quality Assurance, CAPA, Change Control, Document Control, and Training Systems.
- Strong skills with Microsoft Word, Excel, PowerPoint and Visio.
- Knowledge of GMP, ICH, USP, EP, and CFR requirements and regulations.
- Comfortable working in startup environments and communicating cross-organizationally site and possible other global positions.
- Ability to communicate clearly and in an engaging manner with colleagues of various levels of experience and management.
- Experience in building a training program is preferred.
- Experience of internal and external audit is a plus.
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.