Serve as the Subject Matter Expert (SME) and quality approver for GxP documentation related to new products and projects throughout the project lifecycle.
Ensure operational compliance with US and international regulatory agencies and guidelines, including FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.
Review and approve Change Control/Management Documents for product or process changes.
Act as a primary contact for FDA and other regulatory agency audits.
Lead efforts to resolve product complaints, exceptions, corrective actions, out-of-specifications (OOS), and safety concerns.
Collect, analyze, and report QA data to ensure regulatory compliance, identify trends, and highlight areas for improvement.
Conduct quality audits and provide corrective action recommendations based on audit findings.
Develop procedures, statistical evaluations, and system remediation plans.
Demonstrate adaptability in a fast-paced, dynamic environment.
Effectively communicate and positively influence diverse internal and external stakeholders.
Promote a safe and quality-focused work environment by providing training, fostering awareness, and ensuring compliance with safety guidelines and SOPs.
Oversee the maintenance of the department, premises, and equipment.
Additional responsibilities may include developing sampling plans and SOPs, delivering quality training, participating in Material Review Board meetings, and assisting in the preparation of regulatory submissions.
Develop project timelines for quality and validation initiatives, and lead a sub-team to achieve key milestones.
Qualifications:
Bachelor's degree in Biology, Chemistry, Life Sciences, or a related field is required.
A minimum of 8 years of relevant experience.
At least 3 years of experience supporting on-site inspections by regulatory agencies.
Strong background in investigating deviations and variances.
Comprehensive knowledge of regulatory guidelines regarding the establishment, validation, and documentation of testing procedures, equipment, processes, and facility systems.
Expertise in cGMP guidelines and their application in a controlled aseptic environment.
Proven ability to collaborate with cross-functional teams to resolve issues, close compliance gaps, and achieve compliant outcomes.
Experience with statistical analysis tools.
Proficiency in Microsoft Office suite; experience with MS Project and project timeline management is highly preferred.
