Sr. Specialist, Qa, Training

The Sr. Specialist for Training will be part of a cohesive team responsible for supporting cGMP mRNA clinical drug substance and drug products produced both internally and externally at Client. The successful candidate will have experience in managing a team to deliver a robust and compliant training and documentation system to support a growing clinical site. The incumbent will have solid decision-making skills and demonstrated ability to fluidly interact cross functionally.

Heres What Youll Do

Lead and grow a team to support training needs for a growing GMP site

Provide leadership, guidance and coaching for all direct reports to maintain an engaged and productive workforce

Manage an effective GMP training program within the clinical site to ensure employees are fully aware of GMP expectations and requirements and effectively demonstrate this awareness as part of their core competencies

Collaborate with clinical GMP area managers to analyze needs and develop, implement, and measure effectiveness of training and work with individual department leads to develop job specific training matrices

Create and track Training metrics/reports to measure training effectiveness and accountable for escalation of training quality system issues

Oversee the management of cGMP training files in the electronic document management system

Provide support and oversight of course development, training structure, and design across the site

Organize and present live and virtual training sessions to groups and individuals (e.g., annual GMP)

Responsible for the enhancement and maintenance of the Quality Documentation System

Business administrator for electronic documentation management systems (Veeva QualityDocs EDMS) and Learning Management System (SuccessFactors LMS)

Establish, maintain, and continuously improve controls to ensure the integrity of records, control of in-process documentation and Oversee document periodic review process

Implement practices in document and records, control, management, and retention to ensure training, compliance, data integrity, and continuous improvement for the rapidly expanding site

Identify trends, monitors document control and records performance and metrics, and participates in quality management review (QMR).

Maintain issue master batch records, logbooks, and notebooks for internal manufacturing operations and quality control operations.

Prepare records for scanning, ensuring consistency and accuracy with paper hard copies

Work cross functionally with other site and global training and documentation organizations with Client to share best practices and ensure alignment to deliver a robust training program and documentation system.

Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

Bachelors Degree in Chemistry, Biology or a related scientific discipline, or equivalent work experience

BS/BA with 5-7 years of biotech or pharma experience, MS with 3-5 years experience, or PhD with 0-2 year experience

Heres What Youll Bring to the Table (Preferred Qualifications)

A desire to make an impact as part of a high-growth, transformational company that is Product, Relentless, Curious, and Collaborative.