JB 205 - Project Manager - Quality Assurance

Job Description

1. Coordinate regulatory projects between internal departments, manufacturing facilities, regulatory teams, and external regulatory pharmacists, consultants, and agents.
2. Work closely with Quality Assurance (QA), Quality Control (QC), Production, R&D, Packaging Development, and other manufacturing-related departments to obtain required technical information and documentation.
3. Review regulatory observations, technical queries, and documentation requests received from regulatory authorities, consultants, distributors, and international partners.
4. Convert regulatory and technical requirements into clear action points, assign responsibilities, establish timelines, and follow up with the relevant departments until completion.
5. Review technical documents, including product specifications, certificates of analysis, stability data, analytical methods, validation documents, manufacturing information, artworks, and GMP-related records.
6. Coordinate the preparation and availability of dossiers, product samples, reference standards, impurity standards, working standards, legalized documents, certificates, and other submission requirements.
7. Identify missing information, documentation discrepancies, technical inconsistencies, and potential delays and coordinate with the responsible departments to resolve them.
8. Prepare professional emails, meeting minutes, technical clarifications, project updates, action lists, and status reports for internal and international stakeholders.
9. Maintain detailed trackers for product registrations, regulatory observations, documentation status, samples, standards, departmental responsibilities, and submission timelines.
10. Support regulatory submissions, renewals, variations, deficiency responses, and product-launch activities by ensuring that all technical, analytical, and manufacturing inputs are complete and provided within the required timelines.

Requirements

Requirements

1. Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related discipline is mandatory.
2. Minimum six years of experience in Quality Assurance, Quality Control, pharmaceutical production, regulatory affairs, formulation development, technology transfer, or another technical function within a finished formulation manufacturing environment.
3. Strong understanding of pharmaceutical manufacturing, GMP documentation, finished product specifications, analytical reports, stability data, validation documents, certificates of analysis, and regulatory dossier requirements.
4. Excellent written and spoken English, with the ability to prepare professional emails, meeting minutes, technical summaries, action plans, and project status reports.
5. Strong coordination, follow-up, problem-solving, and project-tracking capabilities, with the ability to work effectively with QA, QC, Production, R&D, regulatory teams, and international stakeholders.

Benefits

Benefits

1. Option to work from home or from the office depending on operational and project requirements.
2. Flexible working schedule with outcome-driven performance expectations and responsibility for defined regulatory project milestones.
3. Exposure to international pharmaceutical regulatory operations and product registration processes across Central America and other global markets.
4. Opportunity to transition from a routine QA, QC, production, or regulatory role into cross-functional technical project management.