Accountable for coordinating and overseeing quality activities in the R&D Quality Assurance area and other departments as necessary to meet the goal of compliant project completion and client satisfaction. Responsible for planning for managing the evaluation, implementation, execution and follow-up on quality systems in support of but not limited to GMP/EU compliance, Phase I/II/III and release of R&D raw materials, intermediates & finished product for clinical study at the manufacturing/packaging facility. Review and approve, but not limited to, R&D SOPs, analytical methods, analytical report sheets, protocols, reports, cleaning protocols, batch records, investigations, CAPAs, change controls, and equipment qualification documents. Responsible to supervise and provide QA oversight for R&D in-process and finished product testing, API, raw material and packaging material sampling (including swab sampling), review and approval of master batch records and batch records of R&D work. Provide oversight of product labeling, including clinical trial materials at all phases.
Interfaces with every R&D department and the formal Quality organization.
- Ensures all R&D records and results for all phase products meet specifications prior to release batches or materials for clinical study
- Prepare Trend and Performance reports
- Manages work in process for the facility to facilitate timely release of finished product, raw materials, intermediates, third party products which meets Frontida BioPharm and GMP requirements through review of manufacturing and testing documentation and sampling as required. Oversee document archiving to ensure R&D data and notebook materials are organized and retrievable.
- Assures lab and production investigations are properly conducted, compliant, and closed prior to release.
- Evaluates existing quality systems in the R&D facility and enacts quality improvements as necessary.
- Troubleshoots R&D quality issues. Forms corrective action teams to resolve issues.
- Coordinates investigation and documentation requests during the investigation.
- Oversees the process optimization, scale-up and registration batch manufacture for new products including necessary analytical methods.
- Evaluates potential suppliers for new products, assessing technical abilities and quality systems to support R&D development and commercial manufacturing activities.
- Creates/updates/biennially reviews R&D SOPs and assists in policy creation.
- Creates and implements R&D CAPA, commitments, and effectiveness checks as necessary.
- Approves and or Creates – R&D SOPs, Change Controls, protocols, reports, master batch records, equipment qualifications, annual product reviews, analytical method and specifications, COA , COC, investigation plans and investigation reports.
Knowledge and Skills
- Bachelor’s Degree (minimum) in Technical Area (Chemical Engineering, Pharmacy, Chemistry) or Bachelor’s Degree with 7+ years’ experience in Quality Assurance, with previous supervisory experience in the pharmaceutical industry is preferred. Pharmaceutical solid-dosage experience preferred
- Knowledge of contemporary quality systems and processes
- Strong knowledge of GMP/CFR/ICH/EU, Regulatory Validation requirements and industry standards
- Prior experience in conducting/approving manufacturing investigations is required
- Ability to set priorities and manage multiple tasks
- Effective interpersonal skills
- Solid project management skills
- Strong management abilities
- Experience with Electronic quality management system is desirable
- Computer literate in various office and position related technical applications
- Ability to read/write and comprehend complex instructions, correspondence and memos
- Ability to effectively present information in a one-on-one or group situation
- Ability to work with mathematical concepts
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
- Other duties as assigned.