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.