Establish quality management plans and provide roadmap linking plans to processes/SOPs.

Establish required quality systems such as change control, product release, deviations, Corrective Actions Preventative Actions (CAPAs), training, validation, auditing; identify gaps in established systems.

Oversight/management of outsourced services/vendors per standardized SOPs 

Establish quarterly meetings as part of the Quality Management system by preparing and presenting meeting agenda contents, and to cross-functional teams and stakeholders. 

Establish and develop QA onboarding training programs.

Establish, develop, and implement cross-functional team training programs. 

Author SOPs/policies, oversee training, conduct SOP annual reviews, provide compliance metrics. 

Conduct training on pertinent topics such as SOPs/procedures, management objectives, government agency interactions, written regulatory communications.

Conduct quality control activities including review of data and documentation, cross-checking to source, identifying/correcting inconsistencies, report reviews.

Build robust naming conventions, electronic filing libraries, and archiving systems; manage files and document archives.

Author and establish technical documents, Standard of Operating Procedures (SOPs), and Work Instructions.

Establish GXP systems including but not limited to Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) guidelines per 21 CFR FDA, ICH E6(R2)(R3), regulatory guidelines.

Establish and manage complete audit programs, audit tracking, and scheduling for all regulated activities including audits of internal functions, external vendors/contracted service providers/consultants, GXP documentation/data, validation packages, electronic systems.

Conduct audit assignments, audit prep, execution, report writing, follow up/closure of audit observations.

Provide training to shop floor QAs for regulatory inspection readiness. 

Provide QA and regulatory support (such as Pre-Approval Inspections (PAI), Tech Transfer support, and in-process streamlining) for agency submissions and already submitted Investigative New Drug(s) (INDs).

Create consistent and compliant product release processes to ensure safety and quality prior to use, including review of process batch records, specifications, and test data for compliance with specifications.

Provide QA and Regulatory guidelines for European Union Good Data Protection EU GDPR policies.

Identify mechanisms for keeping quality plans current to ensure ongoing compliance; establish and oversee Quality Management Review processes 

Manage and/or create Quality and Technical Agreements with critical service providers