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Senior GMP QC Compliance Specialist (Remote) at Pace® Analytical Services - ApplyBlast

Senior GMP QC Compliance Specialist (Remote)

Pace® Analytical Services

4 months ago

Philippines

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior QC Compliance Specialist ensures that analytical and quality control operations for mRNA and biologics manufacturing adhere to GxP regulations and global regulatory expectations. This strategic role acts as a compliance partner to laboratory leadership, driving a culture of quality, leading audit readiness, and overseeing the quality management system. The incumbent provides expert guidance on regulatory requirements, manages regulatory submissions, and mentors staff on data integrity and compliance principles.

Responsibilities

Serve as the primary compliance authority for QC laboratory operations supporting mRNA and biologics
Lead audit readiness initiatives and act as the SME during regulatory inspections
Oversee the lifecycle management of QC controlled documents and quality management system activities
Author and review regulatory submission content including CTD Module 3 and validation reports
Champion data integrity culture and conduct periodic assessments of laboratory systems and records

Skills

Qualifications

BS in Life Sciences, Chemistry, or related field5+ years of progressive experience in pharmaceutical QC or QAExperience managing FDA or EMA regulatory inspectionsKnowledge of FDA 21 CFR Parts 211, 600-680, and EU GMP GuidelinesProficiency with electronic document management systems (eDMS)