ASC Therapeutics

Genes and Cells for Cure

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The QAD Manager is responsible for establishing the GMP Document System to support ASC therapeutics 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 ASC requirement. In addition, you will be responsible for establishing and maintaining the training program. The position will report to the Quality Head and may manage others.

KEY RESPONSIBILITIES:

  1. Establish the GMP Document System to support ASC Gene/Cell therapy drug development
    1. Revise corporate guidance procedures covering various systems per the ASC quality policy and manual and/or senior management determination.
  2. Manage the life-cycle of documents (creation, distribution, revision, review cycle, implementation) including periodic review cycles.
    1. Issue document numbers/templates, reconcile, file, and archive technical protocols/reports, validation protocols/reports.
    2. Maintain information accurately following GDP to support operations and overall life cycle of documents and records.
    3. Manage the distributed documents and ensuring that the documents are the current version; ensure the integrity and consistency of the distributed documents.
    4. 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
    1. 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.
    2. Maintain and follow ASC procedures for issuance, receipt, reconciliation, filing, and archives on-site and/or off-site. 
    3. Ensure Superseded versions of GMP documents are retained along with current effective versions.
    4. Assure only the current, effective version of a GMP document is employed at the point of use.
  4. GMP Document Archiving and Retention
    1. 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.
    2. Manage the site’s retention schedule and archival process to ensure that documents are appropriately retained, retrievable and destroyed.
  5. Establish and maintain the ASC training program
    1. Create and maintain training items, training curricula and training assessments.
    2. Manage following training functional parts: training materials, training method, trainer qualification, training plan and training records and training evaluation.
    3. Work with SMEs in developing On the Job Training and in managing the Training Effectiveness program.
    4. Manage the process for the filing and retrieval of completed Training Records.
    5. Ensure that training curricula are appropriately updated per changed GMP documents.
    6. Assists in the development and maintenance of training content, training curricula and metrics in compliance with policies, procedures, and applicable
  6. Other duties as assigned.

DESIRED QUALIFICATIONS:

  • BS degree in a scientific discipline.
  • 8+ 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.

Apply now!